Clinical Trial: A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Multicenter Randomised Study Comparing the Antiviral Efficacy of Pegylated Interferon-alfa-2a Plus Placebo vs. Pegylated Interferon-alfa-2a Plus Tenofovir for the Treatment of
Brief Summary: This randomized, single blind study will compare the antiviral effect of Pegasys (pegylated interferon alfa-2a) plus placebo versus Pegasys plus tenofovir in patients with chronic hepatitis D. Patients will be randomized to receive 96 weeks of therapy with Pegasys (180 micrograms sc weekly) plus either placebo (orally daily) or tenofovir (245mg orally daily). Anticipated time on study treatment is 2+ years, target sample size is <50.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: proportion of patients becoming HDV-RNA negative [ Time Frame: week 96 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology [ Time Frame: weeks 48, 96 and after 24 weeks of follow-up ]
- Safety and tolerability: adverse events, laboratory parameters, vital signs [ Time Frame: throughout 96 weeks of treatment ]
Original Secondary Outcome: Same as current
Information By: Hoffmann-La Roche
Dates:
Date Received: March 16, 2010
Date Started: February 2010
Date Completion: December 2017
Last Updated: March 10, 2017
Last Verified: March 2017
