Hepatic angiography was entirely normal but direct portal venography prior to insertion of the shunt Doxorubicin price revealed tumor staining and a prominent gastric coronary vein (Figure 2 right). The TIPS procedure was associated with improvement in ascites. Contributed by “
“This case reports on an elderly patient with symptomatic Zenker’s diverticulum who was successfully treated with endoscopic septoplasty. A 91 year old male presented with recurrent dysphagia to solids, regurgitation associated

with coughing and choking attacks. The symptoms had been present for approximately 12 months and were recently becoming more bothersome. Barium swallow suggested a Zenker’s diverticulum (Figure 1a). Initial oesophagogastroduodenoscopy

Selleck Dabrafenib (OGD) confirmed a 20 mm Zenker’s diverticulum with some retained food debris. The patient was referred for a surgical opinion, however he was deemed not to be a surgical candidate. The surgical team referred the patient to our unit for consideration of endoscopic treatment. We repeated OGD under conscious sedation with titrated doses of Midazolam and Fentanyl and identified the diverticulum (Figure 1b, black arrow) and the septum (Figure 1B, white arrow). After insertion of a nasogastric tube into the stomach we performed endoscopic myotomy with a needle knife (Figure 1c, white arrow). When the myotomy was completed an Olympus endoclip was placed at the apex of the incision. The patient was discharged from hospital on the same day without any complication. Due to residual symptoms, the procedure was repeated three months later and the myotomy extended. Following the second procedure he had complete symptom resolution and was able to consume a normal diet. He has remained symptom free after 18 months of follow-up. Surgery is the mainstay of treatment for patients with a symptomatic Zenker’s diverticulum and is associated with symptom resolution in up to 96%. The surgical options include open diverticulectomy or diverticulopexy with cricopharyngeal myotomy or alternatively

endoscopic stapling. In symptomatic non-operative candidates or patients unwilling to undergo surgery, endoscopic Zenker’s septoplasty is safe alternative with acceptable outcomes. Studies report complete MCE公司 symptom resolution in up to 82% of patients and a low complication rate with major complications (perforation, neck abscess) in 1.6% and minor complications in 6.1%. Mortality from this procedure has not been reported in the literature. Due to the nature of the procedure there is a learning curve, however this learning curve is unknown, and the opportunity for training is limited. An animal model has been described that may allow for further training in this technique and potentially more widespread application. Contributed by “
“We read with great interest the article by Bini et al.

The combined antiproliferative and metabolism-altering properties of rapamycin may therefore be important in preventing tumor regrowth post-transplantation and may explain the lower incidence of HCC and skin malignancies observed in transplant recipients taking this drug. Calorie restriction is known to extend lifespan21 and its effect is apparently mediated BVD-523 price through mTOR,22 with superoxide-based signals playing a role.23 The effect

of calorie restriction on longevity is highly conserved, because rapamycin also increases murine lifespan, even when administered late in life.24 However, as we have noted above, rapamycin treatment is also associated with insulin resistance (IR), hyperlipidemia, and IS, thus making it important to identify competing downstream mechanisms of the rapamycin/mTOR interaction that may affect aging,

as some groups AZD2281 chemical structure are all ready doing with some success.25, 26 As well as suppressing graft rejection, rapamycin and its analogs have multiple effects with exciting implications for their therapeutic use. By inducing Tregs, rapamycin may prevent the reemergence of autoimmune disease post-transplantation. It may also prevent weight gain, reduce the incidence of malignancy, and increase longevity. However, the negative effect of rapamycin treatment on metabolism, including induction of glucose intolerance and IR, also need to be considered. Regulatory processes are critical for deciding on the balance of efficacy and side effects required for approval of any drug. Occasionally, data prove to be inaccurate or incomplete, and drugs may need to be removed from the market. However, mistaken assumptions and poor study design may also lead to an incorrect interpretation of a drug’s potential benefit and result in its failure to be approved or correctly utilized. Regulatory agencies should be just as eager to identify these oversights and have mechanisms in place to resurrect drugs once new supportive evidence for their beneficial use is 上海皓元 found. The potential for rapamycin to prevent hepatoma recurrence

affects over 1,000 patients in the United States every year (almost one fifth of liver transplant recipients), and promotes graft tolerance in thousands of patients, if the Levitsky hypothesis bears out. To demand stringent new double-blind registration trials is unrealistic, because the drug’s patent life is about to expire. A new paradigm must be developed by the U.S. Food and Drug Administration, together with the physician and scientific communities, to realize the extended therapeutic benefit of this and other drugs for the benefit of all patients. “
“Hepatocellular carcinoma (HCC) is a highly invasive tumor with frequent intrahepatic or pulmonary metastasis, which is the main reason for high recurrence and poor survival of HCC after liver resection.

05). RC-derived diterpenoid C had the inhibitory effects on Hp-induced p65 translocation from cytoplasm into cell nucleus, Hp-stimulant IkBα degradation, the phosphorylation of P65 and IkBα, and the expression of IKKα and IKKβ proteins. Conclusion: NF-κB signal pathway plays an important role in the pathogenesis of chronic gastritis caused by HP. RC-derived diterpenoid C can block NF-κB signal pathway, effectively reducing the secretion of Hp-indeced proinflammatory cytokine and increasing the

secretion of anti-inflammatory cytokine. RC-derived diterpenoid C may become an effective drug for treatment of chronic gastritis. Key Word(s): 1. Diterpenoid C; 2. Helicobacter pylori; this website 3. Nuclear factor-κB; selleckchem 4. inflammation; Presenting Author: 颖 Corresponding Author: 颖 Affiliations: Objective: To discuss the impact and clinical significance of Hp elimination on ghrelin, by detect the difference of serum ghrelin level and ghrelin express in gastric mucosa before and after Hp elimination on upper gastrointestinal disease patients. Methods: Select 40 chronic superficial gastritis cases, 42 chronic atrophic gastritis cases,

41 peptic ulcer cases and 17 gastric adenocarcinoma cases. Hp results of all these cases are positive. Select 40 Hp negative cases as control. Determine MCE公司 serum ghrelin level before and after Hp elimination with ELISA. Determine the

correlation between PG and the changes of glrelin. Determine ghrelin express in gastric mucosa with RT-PCR. Analysis results with statistical method. Results: Comparing with control (30.41 ± 8.97), ghrelin level in PU group increased (35.42 ± 9.87), which in CAG group (18.59 ± 8.19) and CA group (18.33 ± 6.88) decreased, while the changes of ghrelin in CSG group (26.08 ± 9.14) was not statistically significant compared with difference. After Hp elimination, ghrelin level in CSG group increased (P < 0.01) both in serum and in gastric mucosa, Ghrelin level in serum and in gastric mucosa decreased (P < 0.01) in PU group, while changes of which in CAG group was not obvious (P > 0.05). A positive correlation could be found between serum PGI/PGII and serum ghrelin level (r = 0.668, P < 0.01). Conclusion: Conclusion: Hp elimination has an impact on ghrelin level in patients with upper gastrointestinal diseases. The changes of ghrelin level related on pepsinogen I/II. Ghrelin could be used as one of the indexes of gastric mucosa degree of diagnostic and prognostic evaluation. Key Word(s): 1. helicobacter pylori; 2. growth gastritis,; 3.

05). RC-derived diterpenoid C had the inhibitory effects on Hp-induced p65 translocation from cytoplasm into cell nucleus, Hp-stimulant IkBα degradation, the phosphorylation of P65 and IkBα, and the expression of IKKα and IKKβ proteins. Conclusion: NF-κB signal pathway plays an important role in the pathogenesis of chronic gastritis caused by HP. RC-derived diterpenoid C can block NF-κB signal pathway, effectively reducing the secretion of Hp-indeced proinflammatory cytokine and increasing the

secretion of anti-inflammatory cytokine. RC-derived diterpenoid C may become an effective drug for treatment of chronic gastritis. Key Word(s): 1. Diterpenoid C; 2. Helicobacter pylori; Wnt inhibitor 3. Nuclear factor-κB; BTK inhibitor 4. inflammation; Presenting Author: 颖 Corresponding Author: 颖 Affiliations: Objective: To discuss the impact and clinical significance of Hp elimination on ghrelin, by detect the difference of serum ghrelin level and ghrelin express in gastric mucosa before and after Hp elimination on upper gastrointestinal disease patients. Methods: Select 40 chronic superficial gastritis cases, 42 chronic atrophic gastritis cases,

41 peptic ulcer cases and 17 gastric adenocarcinoma cases. Hp results of all these cases are positive. Select 40 Hp negative cases as control. Determine 上海皓元医药股份有限公司 serum ghrelin level before and after Hp elimination with ELISA. Determine the

correlation between PG and the changes of glrelin. Determine ghrelin express in gastric mucosa with RT-PCR. Analysis results with statistical method. Results: Comparing with control (30.41 ± 8.97), ghrelin level in PU group increased (35.42 ± 9.87), which in CAG group (18.59 ± 8.19) and CA group (18.33 ± 6.88) decreased, while the changes of ghrelin in CSG group (26.08 ± 9.14) was not statistically significant compared with difference. After Hp elimination, ghrelin level in CSG group increased (P < 0.01) both in serum and in gastric mucosa, Ghrelin level in serum and in gastric mucosa decreased (P < 0.01) in PU group, while changes of which in CAG group was not obvious (P > 0.05). A positive correlation could be found between serum PGI/PGII and serum ghrelin level (r = 0.668, P < 0.01). Conclusion: Conclusion: Hp elimination has an impact on ghrelin level in patients with upper gastrointestinal diseases. The changes of ghrelin level related on pepsinogen I/II. Ghrelin could be used as one of the indexes of gastric mucosa degree of diagnostic and prognostic evaluation. Key Word(s): 1. helicobacter pylori; 2. growth gastritis,; 3.

We examined PFA-100® results in a large paediatric patient population diagnosed specifically with δ-PSPD, and determined the relationship between PFA-100®

and platelet electron microscopy (the gold standard for diagnosis). This study is a retrospective review of patients <19 years of age diagnosed with δ-PSPD at Nationwide Children’s Hospital from 2008 to 2010. To examine the correlation between PFA-100® and average number of granules per platelet we used Spearman’s Rho as a non-parametric measure of dependence. A total of 105 patients diagnosed with δ-PSPD were included, of which 99 patients underwent PFA-100® testing. Of those tested 46% had at least one abnormal closure time, whereas 16% had abnormal results for both cartridges. We found no statistical correlation between C-EPI closure time and average number PD-0332991 mouse of granules per platelet (ρ= −0.0095, P-value = 0.9328), nor between C-ADP closure time and the average number of granules (ρ = 0.0315, P-value = 0.7798). The PFA-100®, a widely used screening test for suspected bleeding disorders, did not correlate with presence or severity of δ-PSPD as determined by platelet electron microscopy. When evaluating patients with suspected bleeding disorders, PFA-100® alone cannot be used to rule out the presence of a δ-PSPD. “
“Summary.  There is a potential for significant paradigm shift in

the assessment of haemostasis from the conventional AZD5363 cell line plasma recalcification times, such as prothrombin time (PT) and activated partial thromboplastin time (APTT), which correspond to artificially created compartments of haemostasis to tests that assess the entire process in a more physiological and holistic manner. These include the thrombin generation test, thromboelastogram and the clot wave form analysis. While these tests have been described many years ago, there is renewed interest in their use with modified technology for assessing normal haemostasis and its disorders. Although early data suggest that they can provide much greater information

regarding the overall haemostasis process and its disorders, many challenges remain. Some of them are possible only on instruments that are proprietary technology, expensive and are not widely available. 上海皓元 Furthermore, these tests need to be standardized with regard to their reagents, methodology and interpretation, and finally, much more data need to be collected regarding clinical correlations with the parameters measured. Haemostasis and its abnormalities have been traditionally assessed by plasma clotting times, such as the prothrombin, activated partial thromboplastin and thrombin times[1]. These times depend on the thrombin dependent conversion of fibrinogen to fibrin, but note only the initiation of this process and not its speed or total extent. Factor assays based on these tests have defined the different coagulation disorders including haemophilia[2,3].

We examined PFA-100® results in a large paediatric patient population diagnosed specifically with δ-PSPD, and determined the relationship between PFA-100®

and platelet electron microscopy (the gold standard for diagnosis). This study is a retrospective review of patients <19 years of age diagnosed with δ-PSPD at Nationwide Children’s Hospital from 2008 to 2010. To examine the correlation between PFA-100® and average number of granules per platelet we used Spearman’s Rho as a non-parametric measure of dependence. A total of 105 patients diagnosed with δ-PSPD were included, of which 99 patients underwent PFA-100® testing. Of those tested 46% had at least one abnormal closure time, whereas 16% had abnormal results for both cartridges. We found no statistical correlation between C-EPI closure time and average number Ipilimumab chemical structure of granules per platelet (ρ= −0.0095, P-value = 0.9328), nor between C-ADP closure time and the average number of granules (ρ = 0.0315, P-value = 0.7798). The PFA-100®, a widely used screening test for suspected bleeding disorders, did not correlate with presence or severity of δ-PSPD as determined by platelet electron microscopy. When evaluating patients with suspected bleeding disorders, PFA-100® alone cannot be used to rule out the presence of a δ-PSPD. “
“Summary.  There is a potential for significant paradigm shift in

the assessment of haemostasis from the conventional click here plasma recalcification times, such as prothrombin time (PT) and activated partial thromboplastin time (APTT), which correspond to artificially created compartments of haemostasis to tests that assess the entire process in a more physiological and holistic manner. These include the thrombin generation test, thromboelastogram and the clot wave form analysis. While these tests have been described many years ago, there is renewed interest in their use with modified technology for assessing normal haemostasis and its disorders. Although early data suggest that they can provide much greater information

regarding the overall haemostasis process and its disorders, many challenges remain. Some of them are possible only on instruments that are proprietary technology, expensive and are not widely available. 上海皓元医药股份有限公司 Furthermore, these tests need to be standardized with regard to their reagents, methodology and interpretation, and finally, much more data need to be collected regarding clinical correlations with the parameters measured. Haemostasis and its abnormalities have been traditionally assessed by plasma clotting times, such as the prothrombin, activated partial thromboplastin and thrombin times[1]. These times depend on the thrombin dependent conversion of fibrinogen to fibrin, but note only the initiation of this process and not its speed or total extent. Factor assays based on these tests have defined the different coagulation disorders including haemophilia[2,3].

The homo-deletion of TAT gene was further confirmed by southern blot analysis (Fig. 1C) using a full-length TAT probe. Compared with the TAT MAPK Inhibitor Library band detected in paired nontumor liver tissue, a very weak band was detected in HCC tissues in H12 and H36. To identify the homo-deleted region, five sets of primers

were designed to amplify TAT, GST3 (≈30 kb from the 3′ of TAT) and K2F gene (≈90 kb from the 3′ of TAT, Fig. 1D). PCR results indicated that the homo-deletion region in H12 was from exon 4 to 11 of TAT, whereas the deleted region in H36 was from exon 4 of TAT to GST3 (Fig. 1D). Semiquantitative reverse-transcription PCR (RT-PCR) was used to investigate the expression status of TAT in 50 pairs of primary HCCs. Compared with their paired nontumor liver tissues, down-regulation of TAT was detected in 28/50 (56%) of HCCs (Fig. 2A; Table 1). The results were further confirmed by qPCR (Fig. 2B) and northern blot analysis. Down-regulation of TAT was detected in all seven tested cases including absent expression of TAT in six cases (Fig. 2C). Down-regulation of TAT was also detected in 3/6 (50%) of HCC cell lines compared with that in MIHA, an immortalized liver cell line (Fig. 2D).

TAT protein expression status was further studied in 148 primary HCCs by IHC using a tissue microarray. Compared with their paired nontumor Cabozantinib liver tissues, down-regulation of TAT protein was observed in 77/138 (55.8%) of informative HCCs (Fig. 2E). To determine whether the down-regulation of TAT was associated with aberrant methylation, the HCC cell line QGY-7703 was treated with 5-Aza, a DNA methyltransferase inhibitor. After

5-Aza treatment, TAT expression levels were dramatically increased, indicating that methylation of the TAT was associated with the down-regulation of TAT in HCC (Fig. 3A). The upstream sequence medchemexpress of TAT gene (−1-6761) was analyzed using the CpG-island finder and plotting tool (http://www.ebi.ac.uk/Tools/sequence.html) and one CpG-island (CGI) at −4888-5396 (a total of 23 CpG sites in a 509-basepair region) was found (Fig. 3B). To determine whether epigenetic silencing of TAT in HCC cells is regulated by this 5′-CGI, MSP using methylation- or unmethylation-specific primers was performed in HCC cell lines and primary HCCs to investigate the methylation status of TAT. In three HCC cell lines (QGY-7703, BEL7402, and Hep3B) with absent expression of TAT, only the methylated allele of TAT was detected (Fig. 3C). Both methylated and unmethylated alleles were found in 7701 cells with weak TAT expression. In contrast, no methylated allele was observed in one immortalized liver cell line (MIHA) and two HCC cell lines (HepG2 and PLC8024) with TAT expression (Fig. 3C). These data indicated that promoter methylation might be required for the tissue-restricted TAT expression. We next investigated the methylation frequency of TAT in 50 primary HCC tumors and their paired nontumorous tissues by MSP.

All patients consented to genetic investigation for IL-28B genetic variants at rs8099917. Seven patients had genotype TT, 9 patients had genotype TG, and

no patients had genotype GG at rs8099917. Results: In 5 (4 from the relapse group and 1 from the break-through group) of 16 patients, serum levels of HCV-RNA quantified by RT-PCR decreased constantly; 3 had the TT genotype and 2 had the TG genotype. In 4 (3 from the relapse group and 1 from the break-through group) of 5 patients, serum HCV-RNA subsequently became undetectable; 2 had the TT genotype and 2 had the TG genotype. Levels of serum transaminases remained within normal limits in 5 patients (4 belonged to the relapse group and 1 to the break-through group); Cisplatin nmr NVP-LDE225 mw 3 had the TT genotype and 2 had the TG genotype. Conclusion: Although patients who failed to obtain SVR by PEG-IFN plus RBV combination therapy should be administered a new triple therapy, administration of 90 μg PEG-IFN-alpha 2a every 2 weeks is thought to be useful for patients who cannot receive the new triple therapy for some reason such as aging or anemia, even if relapse or break-through occurred prior to PEG-IFN plus

RBV combination therapy irrespective of their IL-28 genotypes at rs8099917. Key Word(s): 1. chronic hepatitis C Presenting Author: HENDRA KONCORO Additional Authors: KETUT MARIADI, GDE SOMAYANA, GUSTI AGUNG SURYADARMA, NYOMAN PURWADI, DEWA NYOMAN WIBAWA Corresponding Author: HENDRA KONCORO Affiliations: Department of Internal Medicine, Division of Gastroenterohepatology, Udayana University/Sanglah Hospital, Denpasar Objective: Findings MCE公司 of liver cirrhosis are usually accompanied with screening endoscopy for large esophageal varices (EV) that may benefit from prophylactic measures. The aim of this study was to identify whether Model

for End-stage Liver Disease (MELD) score, Child-Turcotte-Pugh (CTP) score, AST to platelet ratio index (APRI), FiB4 index, and laboratory tests could predict the presence of large EV among patients with liver cirrhosis in Sanglah Hospital Denpasar. Methods: A total of 90 hospitalized liver cirrhosis patients from September 2012 until March 2014 were restrospectively analyzed. Variables used in the analysis included age, sex, etiology of cirrhosis, CTP classification, MELD score, APRI, FiB4 index, platelet count, serum creatinine, and liver function tests. The presence of large EV was correlated with those characteristics. Univariate and multiple regression analysis were used to determine which factors may predict large EV. Results: Of ninety (90) patients enrolled, 66 were male (73.3%) and 24 were female (26.7%); majority with chronic hepatitis B. Sixty (66.7%) of the 90 patients were found to have large EV. The distribution of large EV according to CTP classification was as follows: A, 63.16%; B, 62.8% and C, 75%. Large EV was independently associated with total bilirubin higher than 1.9 mg/dL (p = 0.

“
“Summary.  Haemophilia A is characterized by the occurrence of frequent spontaneous

intra-articular and intramuscular bleeding. If inadequately treated, it results in progressive damage to joints and muscles leading to crippling deformities and musculoskeletal dysfunction. These complications result in lifelong chronic ALK inhibitor pain and disability that may greatly affect the patients’ mood. We aimed to evaluate the musculoskeletal function in our haemophilia A patients and its correlation to depressed mood in these patients and determine the impact of degree of factor VIII deficiency, different replacement therapy regimens and frequency of hemarthrosis, on both musculoskeletal function and mood. A cross-sectional study was carried out on 50 adolescent haemophilia A patients. Musculoskeletal function was assessed using Functional Independence Score for Hemophilia (FISH) and mood status was assessed using MLN2238 chemical structure Beck Depression Inventory—Short Form (BDI-SF). The mean FISH

score was 23.32 ± 4.69 (range 13–28) and the tasks that obtained lower scores were step climbing, squatting and walking. Of our 50 patients included, 16(32%) were not depressed, 18(36%) were with mild depression, 11(22%) were with moderate depression and 5(10%) were with severe depression. There was a highly significant negative correlation between mean FISH score and mean BDI-SF score (P < 0.001). The better the replacement therapy regimen, the better the musculoskeletal function that could be obtained in haemophilia A patients and the better the mood. "
“IB1001 trenacog alfa is an investigational recombinant factor IX (FIX) for the treatment and prevention of bleeding in individuals with haemophilia B. To compare the pharmacokinetics (PK) of IB1001 with nonacog alfa in individuals 上海皓元医药股份有限公司 with haemophilia B and to assess the relationship between sialylation and PK of IB1001 (NCT00768287). A randomized, double-blind, non-inferiority, cross-over study conducted in participants aged ≥12 years weighing ≥40 kg, with severe or moderately severe haemophilia B (FIX activity ≤2 IU dL −1). PK parameters were derived using observed FIX concentration levels and actual PK sampling times,

and repeated in a subset of participants who had received IB1001 prophylaxis for 4–18 months. A retrospective analysis was conducted in subgroups according to the sialylation levels of IB1001 (50.8, 57.8–59.0%, or 71.7%). In the 32 adolescent and adult males evaluated, there were no clinically meaningful differences in PK parameters between those receiving IB1001 75 IU kg−1 or nonacog alfa. The lower limit of the one-sided 95% confidence interval for the ratio of AUC0-t and AUC0-∞ (IB1001/nonacog alfa) was 0.90, establishing non-inferiority. Terminal phase half-lives were similar (29.7 ± 18.2 h for IB1001 and 33.4 ± 21.2 h for nonacog alfa). The PK results were stable for up to 18 months of IB1001 exposure; the impact of sialylation levels was not clinically meaningful.

“
“Summary.  Haemophilia A is characterized by the occurrence of frequent spontaneous

intra-articular and intramuscular bleeding. If inadequately treated, it results in progressive damage to joints and muscles leading to crippling deformities and musculoskeletal dysfunction. These complications result in lifelong chronic Ibrutinib pain and disability that may greatly affect the patients’ mood. We aimed to evaluate the musculoskeletal function in our haemophilia A patients and its correlation to depressed mood in these patients and determine the impact of degree of factor VIII deficiency, different replacement therapy regimens and frequency of hemarthrosis, on both musculoskeletal function and mood. A cross-sectional study was carried out on 50 adolescent haemophilia A patients. Musculoskeletal function was assessed using Functional Independence Score for Hemophilia (FISH) and mood status was assessed using Selleck MAPK Inhibitor Library Beck Depression Inventory—Short Form (BDI-SF). The mean FISH

score was 23.32 ± 4.69 (range 13–28) and the tasks that obtained lower scores were step climbing, squatting and walking. Of our 50 patients included, 16(32%) were not depressed, 18(36%) were with mild depression, 11(22%) were with moderate depression and 5(10%) were with severe depression. There was a highly significant negative correlation between mean FISH score and mean BDI-SF score (P < 0.001). The better the replacement therapy regimen, the better the musculoskeletal function that could be obtained in haemophilia A patients and the better the mood. "
“IB1001 trenacog alfa is an investigational recombinant factor IX (FIX) for the treatment and prevention of bleeding in individuals with haemophilia B. To compare the pharmacokinetics (PK) of IB1001 with nonacog alfa in individuals 上海皓元 with haemophilia B and to assess the relationship between sialylation and PK of IB1001 (NCT00768287). A randomized, double-blind, non-inferiority, cross-over study conducted in participants aged ≥12 years weighing ≥40 kg, with severe or moderately severe haemophilia B (FIX activity ≤2 IU dL −1). PK parameters were derived using observed FIX concentration levels and actual PK sampling times,

and repeated in a subset of participants who had received IB1001 prophylaxis for 4–18 months. A retrospective analysis was conducted in subgroups according to the sialylation levels of IB1001 (50.8, 57.8–59.0%, or 71.7%). In the 32 adolescent and adult males evaluated, there were no clinically meaningful differences in PK parameters between those receiving IB1001 75 IU kg−1 or nonacog alfa. The lower limit of the one-sided 95% confidence interval for the ratio of AUC0-t and AUC0-∞ (IB1001/nonacog alfa) was 0.90, establishing non-inferiority. Terminal phase half-lives were similar (29.7 ± 18.2 h for IB1001 and 33.4 ± 21.2 h for nonacog alfa). The PK results were stable for up to 18 months of IB1001 exposure; the impact of sialylation levels was not clinically meaningful.