Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With HBeAg-Positive Chronic Hepatitis B Virus (HBV)
Status: Completed
Protocol number: ML18089
Sponsor: Roche Romania
Company division: Pharmaceutical
Official Scientific Title: A study of PEGASYS in patients pretreated with lamivudine or interferon who have HBeAg-positive hepatitis B infection
Brief summary: This study will evaluate the efficacy and safety of PEGASYS in lamivudine- or interferon-pretreated patients with HBeAg-positive HBV. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is 80.
Study phase: III
Study type: Interventional; Treatment; Non-Randomized; Open Label; Uncontrolled; Single Group; Safety/Efficacy study
Condition: Hepatitis B, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. Efficacy:HBV DNA <100,000 copies/mL. HBe seroconversion defined as : loss of HBeAg and presence of anti-HBe
Key secondary outcomes: 1. Efficacy at end of treatment and follow-up: loss of HBsAg and seroconversion, HBV-DNA below limit of quantification, ALT normalization, combined response.
Inclusion criteria:
- adult patients 18-65 years of age;
- HBsAg +ve, HBeAg +ve for >=6 months before study start;
- patients with HBV who have received lamivudine or interferon, but have either not responded or relapsed.
Exclusion criteria:
- no antiviral or interferon-based therapy within 6 months;
- decompensated liver disease;
- co-infection with hepatitis A, C, D, or HIV;
- any medical condition associated with chronic liver disease, other than viral hepatitis B.
Gender: Males or Females
Age limits: Min: 18 Years Max: 65 Years
Accepts healthy volunteers: No
Trial registration date: 10/28/2005
Date last updated: 9/29/2008
Link to trial result
This trial was conducted at the following locations:
Romania
- Bucharest
- Cluj-Napoca
- Constanta
- Iasi
- Timisoara
