Trials / Completed
CompletedNCT01088659
A Study of Pegasys (Peginterferon Alfa 2a) Alone or in Combination With Tenofovir in Patients With Chronic Hepatitis D.
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 Chronic Delta Hepatitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | peginterferon alfa-2a [Pegasys] | 180mcg sc weekly, 96 weeks |
| DRUG | placebo | orally daily, 96 weeks |
| DRUG | tenofovir | 245mg po daily, 96 weeks |
Timeline
- Start date
- 2010-02-16
- Primary completion
- 2017-12-29
- Completion
- 2017-12-29
- First posted
- 2010-03-17
- Last updated
- 2019-01-14
Locations
6 sites across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT01088659. Inclusion in this directory is not an endorsement.