A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.
- Conditions
- Hepatitis D, Chronic
- Interventions
- Registration Number
- NCT01088659
- Lead Sponsor
- Hoffmann-La Roche
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- adult patients, >/=18 years of age
- chronic hepatitis D
- positive for HBsAg >/=6 months, for anti-HDV >/=3 months and for HDV-RNA at screening
- negative pregnancy test; fertile males and women of childbearing age should use two reliable forms of contraception throughout study
- antiviral therapy for chronic hepatitis D within the previous 6 months
- previous therapy with pegylated interferon alfa
- treatment with conventional interferon alfa for >12 months
- hepatitis A or C, or HIV infection
- decompensated liver disease (Childs B-C)
- history or evidence of medical condition associated with chronic liver disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 tenofovir - 1 peginterferon alfa-2a [Pegasys] - 1 placebo - 2 peginterferon alfa-2a [Pegasys] -
- Primary Outcome Measures
Name Time Method proportion of patients becoming HDV-RNA negative week 96
- Secondary Outcome Measures
Name Time Method HDV-RNA levels, HBsAg levels, HBV DNA, biochemical disease activity, liver histology weeks 48, 96 and after 24 weeks of follow-up Safety and tolerability: adverse events, laboratory parameters, vital signs throughout 96 weeks of treatment
Trial Locations
- Locations (6)
Dokuz Eylul University Medical Faculty; Infection
🇹🇷Izmir, Turkey
Istanbul Uni Cerrahpasa Medical Faculty; Gastroenterolgy
🇹🇷Istanbul, Turkey
Ankara University Medical Facility; Hepatology Department
🇹🇷Ankara, Turkey
Uni of Uludag Faculty of Medicine; I, Hastaliklari Anabilim Dali
🇹🇷Bursa, Turkey
Ege Uni Medical Faculty Izmir; Gastroenterology
🇹🇷Izmir, Turkey
Dicle Uni Medical Faculty; Gastroenterology
🇹🇷Diyarbakir, Turkey