Health Condition 1: null- Chronic Hepatitis B
Conditions
Interventions
Intervention1: Tenofovir Disoproxil Fumarate (TDF) and Peginterferon α-2a: TDF 300mg PO once daily in combination with Peginterferon α-2a 180 µg subcutaneous injection once weekly for 48 weeks.
Int
Sponsors
Gilead Sciences Inc
Klinera Corporation India
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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 2. Anti-HBV treatment naïve subjects and subjects who have taken oral anti-HBV nucleoside therapy with the last dose >= 24 weeks prior to screening are also eligible. 3. Positive or negative for HBeAg 4. HBV DNA >= 20,000 IU/ml for HBeAg+ subjects and HBV DNA >= 2,000 IU/ml for HBeAg- subjects 5. ALT > 54 U/L and 36 U/L and 6. Creatinine clearance (CLcr) >= 70 mL/min 7. A negative serum pregnancy test is required for female subjects of childbearing potential. 8. All sexually active female subjects of childbearing potential must agree to use a protocol-recommended method of contraception during heterosexual intercourse throughout the study and for 30 days following the last dose of study medication . 9. Lactating female subjects must agree to discontinue nursing before initiation of study investigational medicinal product.
Exclusion criteria
Exclusion criteria: 1. Known bridging fibrosis or cirrhosis and/or decompensated liver disease 2. Absolute neutrophil count 1,500/mm3, platelet 100,000/mm3, hemoglobin 10 g/dL (female) or 11 g/dL (male) 3. Evidence of hepatocellular carcinoma 4. History of severe depression or known severe psychiatric disease 5. History of significant renal, cardiovascular, pulmonary, neurological, autoimmune or bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, history of multiple bone fractures) 6. Thyroid dysfunction 7. Pregnant 8. Co-infection with HIV, HCV or HDV
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects with HBsAg loss at Week 72 following treatment with 48 weeks of TDF plus PEG combination versus PEG alone for 48 weeks or TDF aloneTimepoint: 48 weeks and 120 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| HBsAg loss at Week 72 following treatment with TDF 48 weeks plus PEG 16 weeks combination versus PEG alone for 48 weeks or TDF alone. HBsAg loss at Week 96 and Week 120. HBV DNA level less than 117 IU per mL at Weeks 72, 96, and 120. HBeAg loss & seroconversion & HBsAg seroconversion at Weeks 72, 96, and 120. ALT less than 30 for males and less than 19 for females, ALT less than 42 for males and less than 32 for females at Weeks 72, 96, and 120.Timepoint: 48 weeks and 120 weeks | — |
Countries
Australia, Canada, Democratic People's Republic of Korea, France, Germany, Greece, Hong Kong, India, Italy, Netherlands, Poland, Portugal, Romania, Singapore, Spain, Taiwan, Turkey, United Kingdom, United States of America
Contacts
Public ContactPravin Moily
Klinera Corporation India
Outcome results
None listed