A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
- Conditions
- Hepatitis B, Chronic
- Interventions
- Registration Number
- NCT00922207
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
- adult patients, 18-65 years of age;
- HBeAg+ve for >=3 months;
- positive serum HBV DNA within 3 months prior to entry;
- patients with chronic hepatitis B, either naive to HBV treatment, or not responded/relapsed to nucleoside analogues;
- >=3 months treatment-free interval from nucleotide analogues.
- evidence of decompensated liver disease;
- history or other evidence of a medical condition associated with chronic liver disease othr than viral hepatitis;
- co-infection with active hepatitis A,C or D, or HIV.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 3 Placebo - 1 peginterferon alfa-2a [Pegasys] - 2 Entecavir - 2 peginterferon alfa-2a [Pegasys] - 3 peginterferon alfa-2a [Pegasys] - 1 Adefovir -
- Primary Outcome Measures
Name Time Method Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment Week 100 HBeAg seroconversion was defined as the absence of HBeAg (a negative result for HBeAg) and the presence of hepatitis B e-antibody (anti-HBe/HBeAb) (a positive result for anti-HBe).
- Secondary Outcome Measures
Name Time Method Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 Change From Baseline in Hepatitis B Virus Deoxyribonucleic Acid (HBV DNA) Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 HBV DNA (copies per milliliter \[copies/mL\]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.
Percentage of Participants Who Were HBeAg Negative Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 Change From Baseline in HBsAg Levels at Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 Percentage of Participants With Combined Response Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100 Combined response was defined as having negative HBeAg, HBV DNA less than (\<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 52, 64, 76, 88, and 100 The normal range for ALT is 10 to 40 international units per liter (IU/L).
Trial Locations
- Locations (9)
National Taiwan Uni Hospital; Gastro-Enterology Dept.
🇨🇳Taipei, Taiwan
Taipei Veterans General Hospital; Gastroenterology Division
🇨🇳Taipei, Taiwan
Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
🇨🇳Kaohsiung, Taiwan
Changhua Christian Hospital; Internal Medicine
🇨🇳Changhua, Taiwan
Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
🇨🇳Keelung City, Taiwan
Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
🇨🇳Taoyuan, Taiwan
China Medical University Hospital; Department of Rheumatology
🇨🇳Taichung, Taiwan
Tri-Service Hospital; Dept. of Internal Medicine
🇨🇳Taipei, Taiwan
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
🇨🇳Kaohsiung, Taiwan