CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 24 enrolled
Drug / intervention
FTC/TDFdrug
Likely dose
FTC/TDF 300 mgfrom 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/NCT00936715
NCT00936715Phase 2Completed
CompareCT.gov

A Rollover Protocol to Provide Open-Label Emtricitabine/Tenofovir Disoproxil Fumarate Combination Product to Subjects Completing the GS-US-203-0107 Study

Gilead Sciences·interventional·Posted Jul 10, 2009·Updated Jun 2, 2017

In Brief

A Phase 2 clinical trial evaluating FTC/TDF for Chronic Hepatitis B. Completed, enrolled 24 participants across 4 sites.

Detailed Summary

The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study GS-US-203-0107.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis B
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 10, 2009
Enrollment StartAug 1, 2009
Primary CompletionNov 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 17.0 years ago

Interventions

FTC/TDFdrug

200/300 mg tablet administered orally once daily