Trial information
A Study of PEGASYS (Peginterferon alfa-2a (40KD)) With or Without Ribavirin in Patients With Chronic Hepatitis D (CHD)
Status: No longer recruiting
Protocol number: ML18149
Sponsor: Roche S.p.A.
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study to compare the effect of PEGASYS monotherapy and PEGASYS + ribavirin combination therapy on treatment response in patients with chronic hepatitis D.
Brief summary: This study will compare the efficacy and safety of 48 weeks treatment with PEGASYS montherapy (180 micrograms sc weekly) or PEGASYS (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in patients with chronic hepatitis D. Virologic and biochemical response will be evaluated at the end of treatment, and after 12 months of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is
24.
Study phase: II
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis D, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD)[PEGASYS]
Primary outcome: 1. End of treatment and long term response (normalization of serum transaminases, negative serum HDV RNA and complete response).
Key secondary outcomes: 1. Adverse events, laboratory parameters.
Inclusion criteria:
- adult patients, >=18 years of age;
- positive HDV RNA by PCR;
- positive HBsAg for previous 6 months;
- liver disease consistent with chronic hepatitis.
Exclusion criteria:
- treatment for CHD within previous 3 months;
- positive for hepatitis A, hepatitis C or HIV;
- evidence of decompensated or chronic liver disease;
- systemic antineoplastic or immunomodulatory treatment within past 6 months.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2004
Trial registration date: 05/04/2006
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Italy
