Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) in Patients With HBeAg-Negative Chronic Hepatitis B Virus (HBV)
Status: Completed
Protocol number: ML18092
Sponsor: Roche Bulgaria EOOD
Company division: Pharmaceutical
Official Scientific Title: An open-label, non-randomized study to evaluate the effect of PEGASYS on HBV-DNA in patients with HBeAg-negative chronic hepatitis B infection
Brief summary: This study will evaluate the efficacy, safety, and tolerability of PEGASYS in patients with HBeAg-negative chronic HBV. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Target sample size is
50.
Study phase: IV
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 <20,000 copies/mL at end of follow-up, normalization of ALT values at end of follow-up.Safety: AEs, laboratory parameters
Key secondary outcomes: 1. Efficacy: Loss of HBsAg and seroconversion at end of follow-up, HBV-DNA below limit of quantification at end of follow-up, HBV-DNA suppression <20,000 copies/mL at treatment end, ALT normalization at treatment end
Inclusion criteria:
- adult patients 18-70 years of age;
- positive test result for HBsAg for >6 months;
- naive to treatment for HBV;
- on liver biopsy, liver disease consistent with chronic HBV, with or without compensated cirrhosis.
Exclusion criteria:
- co-infection with hepatitis A, C or D, or with human immunodeficiency virus (HIV);
- decompensated liver disease;
- hepatocellular cancer;
- systemic anti-viral, anti-neoplastic, or immunomodulatory therapy <=6 months before study drug;
- medical condition associated with chronic liver disease.
Gender: Males or Females
Age limits: Min: 18 Years Max: 70 Years
Accepts healthy volunteers: No
Trial registration date: 10/28/2005
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
Bulgaria
- Plovdiv
- Sofia
- Stara Zagora
- Varna
