Trials / Completed
CompletedNCT00932971
HIDIT II - PegIFN-alfa2a Plus Tenofovir in Chronic Delta Hepatitis
A Multicenter Randomised Study Comparing the Efficacy of PegIFN-alfa2a Plus Placebo vs. PegIFN-alfa2a Plus Tenofovir for the Treatment of Chronic Delta Hepatitis-The Hep-Net International Delta Hepatitis Interventional Trial II (HIDIT-II)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- HepNet Study House, German Liverfoundation · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Randomized, double blind study comparing the efficacy of pegylated interferon-alfa2a plus placebo versus pegylated interferon-alfa2a plus tenofovir for the treatment of chronic delta hepatitis. 70 Patients will be randomized 1:1 into the two groups. Treatment duration: 96 weeks. Follow-up: 24 weeks. Long-term-follow-up: until week 358.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PEG-IFN alfa-2a, Tenofovir | Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Tenofovir disoproxilfumarat, 245mg, once daily, orally |
| DRUG | PEG-IFN alfa-2a, placebo | Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Placebo, once daily, orally |
Timeline
- Start date
- 2009-06-01
- Primary completion
- 2017-08-01
- Completion
- 2017-08-02
- First posted
- 2009-07-07
- Last updated
- 2018-01-29
Locations
10 sites across 3 countries: Germany, Greece, Romania
Source: ClinicalTrials.gov record NCT00932971. Inclusion in this directory is not an endorsement.