Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With Lamivudine-Resistant HBeAg-Positive Chronic Hepatitis B (HBV).
Status: No longer recruiting
Protocol number: ML18376
Sponsor: Shanghai Roche Pharmaceuticals Ltd.
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study evaluating the effect of peginterferon alfa-2a (40KD) PEGASYS® or adefovir dipivoxil (ADV) on HBeAg seroconversion in patients with lamivudine-resistant HBeAg-positive chronic hepatitis B
Brief summary: This study will evaluate the efficacy and safety of PEGASYS, or a comparator drug, in patients with lamivudine-resistant HBeAg-positive chronic HBV. Patients will be randomized to receive either PEGASYS for 48 weeks in combination with oral lamivudine for the first 12 weeks, or a comparator drug for 72 weeks in combination with oral lamivudine for the first 12 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Target sample size is
244.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis B, Chronic
Intervention type: Drug
Intervention name: peginterferon alf-2a (40KD)[PEGASYS]
Primary outcome: 1. HBeAg seroconversion (defined as loss of HBeAg and presence of anti-HBe) at week 72.
Key secondary outcomes: 1. Loss of HBeAg; reduction in HBV DNA; ALT normalization; HbsAg seroconversion
Inclusion criteria:
- adult patients 18-65 years of age;
- HBsAg-positive, HBeAg-positive, and anti-HBs-negative for >=6 months;
- receiving lamivudine currently, and for >=6 months;
- HBV-DNA decreased >=2 log during lamivudine treatment on >=1 occasion;
- absence of cirrhosis confirmed by liver biopsy in previous 6 months.
Exclusion criteria:
- other drugs with activity against HBV within the prior 6 months, except lamivudine;
- antiviral, anti-neoplastic, or immunomodulatory therapy <=6 months before study;
- active infection with hepatitis A, C, or D virus, or human immunodeficiency virus;
- decompensated liver disease;
- medical condition associated with another chronic liver disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Anticipated start date: October, 2005
Trial registration date: 12/13/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
China
- Beijing
- Chongqing
- Guangzhou
- Hangzhou
- Hong Kong
- Jinan
- Shanghai
