CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
PEG-IFN alfa-2a, Tenofovir +1 moredrug
Likely dose
PEG-IFN alfa-2a, Tenofovir 180µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00932971
NCT00932971Phase 2Completed
CompareCT.gov

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)

HepNet Study House, German Liverfoundation·interventional·Posted Jul 7, 2009·Updated Jan 29, 2018

In Brief

A Phase 2 clinical trial evaluating PEG-IFN alfa-2a, Tenofovir and PEG-IFN alfa-2a, placebo for Hepatitis D. Completed, enrolled 70 participants across 10 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis D
CountriesGermany, Greece, Romania
CollaboratorsHannover Medical School, Hoffmann-La Roche, Gilead Sciences

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 7, 2009
Enrollment StartJun 1, 2009
Primary CompletionAug 1, 2017
Study CompletionAug 2, 2017
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 17.0 years ago

Interventions

PEG-IFN alfa-2a, Tenofovirdrug

Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Tenofovir disoproxilfumarat, 245mg, once daily, orally

PEG-IFN alfa-2a, placebodrug

Pegylated interferon alfa-2a, 180µg once weekly, subcutaneously; Placebo, once daily, orally