NL-OMON39436CompletedPhase 4
A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon a-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB) - Not applicable
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Gilead Sciences
- Enrollment
- 15
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •Adult subjects (aged 18-75) with CHB (e.g., positive for either serum HBsAg or HBV DNA for at least 6 months) prior to baseline.;Anti-HBV treatment naïve subjects and subjects who have taken oral anti-HBV nucleoside therapy with the last dose greater than or equal to 24 weeks prior to screening are also eligible.;HBV DNA for HBeAg- >= 2000 IU/ml, and HBeAg+ subjects >= 20000 IU/ml.;ALT > 54 U/L and <= 400 U/L for men, and > 36 U/L and <= 300 U/L for women.;Creatinine clearance rate greater than or equal to 80 mL/min
Exclusion Criteria
- •Known bridging fibrosis or cirrhosis and/or decompensated liver disease;Decompensated liver disease;Absolute neutrophil count < 1,500/mm3, platelet < 100,000/mm3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male).;Evidence of hepatocellular carcinoma;Histroy of significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone disease (e.g., osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, multiple bone fractures);History of severe depression or severe psychiatric disease;Thyroid dysfunction;Co-infection with HIV, HCV or HDV
Investigators
Similar Trials
Active, not recruiting
Phase 1
A Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon alfa-2a (Pegasys) versus Tenofovir Disoproxil Fumarate or Peginterferon alfa-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects.EUCTR2010-024586-45-ITGILEAD SCIENCE INC.720
Active, not recruiting
Phase 1
A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon a-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB).Chronic Hepatitis BMedDRA version: 12.1Level: LLTClassification code 10008910Term: Chronic hepatitis BEUCTR2010-024586-45-FRGilead Sciences Inc.751
Active, not recruiting
Phase 4
Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon α-2a vs Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Chronic Hepatitis B (CHB).CTRI/2012/11/003083Gilead Sciences Inc720
Active, not recruiting
Not Applicable
A study in people with long-lasting hepatitis B to assess the effectiveness and safety of a combination of the two drugs Viread and Pegasys compared with each drug given on its own.EUCTR2010-024586-45-ESGilead Sciences Inc.720
Active, not recruiting
Not Applicable
A study in people with long-lasting hepatitis B to assess the effectiveness and safety of a combination of the two drugs Viread and Pegasys compared with each drug given on its own.EUCTR2010-024586-45-DEGilead Sciences Inc.720