CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 286 enrolled
Drug / intervention
GSK2336805 40 mg +4 moredrug
Likely dose
GSK2336805 40 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/NCT01648140
NCT01648140Phase 2Completed
CompareCT.gov

A Phase II Multicenter, Parallel-Group, Randomized, Dose-Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Following 12 Weeks of Oral Administration of GSK2336805 With Pegylated Interferon and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 or 4 Hepatitis C Infection

GlaxoSmithKline·interventional·Posted Jul 24, 2012·Updated Jun 2, 2017

In Brief

A Phase 2 clinical trial evaluating GSK2336805 40 mg, GSK2336805 60 mg, and 3 other interventions for Hepatitis C, Chronic. Completed, enrolled 286 participants across 34 sites in 6 countries.

Detailed Summary

GSK2336805 is a novel hepatitis C virus (HCV) non-structural 5A (NS5A) inhibitor being developed for the treatment of chronic HCV infection. This Phase II, multicenter, parallel-group, randomized, dose-ranging study will assess the safety and tolerability, antiviral activity, and pharmacokinetics of GSK2336805 at 2 dose levels (40 and 60 mg) in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA) in approximately 100 treatment-naïve subjects with chronic genotype 1 HCV infection. In a separate nonrandomized single-arm cohort, up to 15 treatment-naïve subjects with genotype 4 chronic HCV infection will be enrolled in parallel at the dose level of 60 mg of GSK2336805.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C, Chronic
CountriesBelgium, Bulgaria, France, Germany, Puerto Rico, United States
CollaboratorsPPD Development, LP

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedJul 24, 2012
Enrollment StartAug 1, 2012
Primary CompletionJul 1, 2014
Study CompletionJul 16, 2014
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 13.9 years ago

Interventions

GSK2336805 40 mgdrug

20 mg tablet, round, 10-mm diameter, white to off-white, no markings

GSK2336805 60 mgdrug

30 mg tablet, round, 10-mm diameter, white to off-white, no markings

Pegylated interferon alpha-2adrug

180 microgram per 0.5 mL prefilled syringe for single use

Ribavirindrug

200-mg tablet, capsule-shaped, light blue, film-coated, and debossed with "200" on 1 side and the logo "3RP" on the other side

Telaprevirdrug

375 mg film-coated tablet