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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
280
From week -4 to week 2
From week -4 to week 2
From week -4 to week 2
180 micrograms sc weekly, from week 1-48
Changhua Christian Hospital; Internal Medicine
Changhua, Taiwan
Kaohsiung Chang Gung Memorial Hospital; Dept of Internal Medicine
Kaohsiung City, Taiwan
Kaohsiung Medical Uni Chung-Ho Memorial Hospital; Dept of Internal Medicine
Kaohsiung City, Taiwan
Chang Gung Medical Foundation - Keelung; Dept. of Hepato-Gastroenterology
Keelung, Taiwan
China Medical University Hospital; Department of Rheumatology
Taichung, Taiwan
National Taiwan Uni Hospital; Gastro-Enterology Dept.
Taipei, Taiwan
Taipei Veterans General Hospital; Gastroenterology Division
Taipei, Taiwan
Tri-Service Hospital; Dept. of Internal Medicine
Taipei, Taiwan
Chang Gung Medical Foundation - Linkou; Dept. of Hepato-Gastroenterology
Taoyuan, Taiwan
Percentage of Participants With Hepatitis B e-Antigen (HBeAg) Seroconversion at 100 Weeks After Start of Treatment
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).
Time frame: Week 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
HBV DNA (copies per milliliter \[copies/mL\]) represented the viral load for Hepatitis B Virus (HBV), and was considered an indicator of viral replication.
Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participants Who Were HBeAg Negative
Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participant Who Were Both Hepatitis B Surface Antigen (HBsAg) Negative and Hepatitis B Surface Antibody (Anti-HBs/HBsAb) Positive
Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participant With Normal Alanine Aminotransferase (ALT) Levels
The normal range for ALT is 10 to 40 international units per liter (IU/L).
Time frame: Baseline, Weeks 6, 12, 16, 22, 28, 34, 40, 46, 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
Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
Percentage of Participants With Combined Response
Combined response was defined as having negative HBeAg, HBV DNA less than (\<) 100,000 copies/mL, and normal ALT level (10-40 IU/L).
Time frame: Baseline, Weeks 4, 8, 16, 28, 40, 52, 64, 76, 88, and 100
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