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NCT01648140 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging of GSK2336805 in Combination Therapy
A Phase 2 study of Hepatitis C, Chronic, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 286
- Enrollment target
- 20
- Study locations
NCT01648140: Completed Phase 2 study of Hepatitis C, Chronic, sponsored by GlaxoSmithKline.
NCT01648140 is a Phase 2 study of Hepatitis C, Chronic that has completed, run by GlaxoSmithKline. The registered enrollment target is 286 participants, below the 365-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (22% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01648140, a Phase 2 study of Hepatitis C, Chronic, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 286 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
eRVR is defined as plasma HCV ribonucleic acid (RNA) \<lower limit of quantification (LLOQ) and target not detected at Weeks 4 and 12. Participants who discontinued prior to Week 12 assessments or had missing HCV RNA values at Weeks 4 and 12 were treated as non-responders.
Conditions Studied
Interventions
- DRUG Ribavirin
- DRUG Telaprevir
- DRUG GSK2336805 40 mg
- DRUG GSK2336805 60 mg
- DRUG Pegylated interferon alpha-2a
Study Locations (20)
California
- GSK Investigational Site - Anaheim
- GSK Investigational Site - Los Angeles
Florida
- GSK Investigational Site - DeLand
- GSK Investigational Site - Orlando
Georgia
- GSK Investigational Site - Columbus
- GSK Investigational Site - Savannah
Massachusetts
- GSK Investigational Site - Brockton
- GSK Investigational Site - Springfield
North Carolina
- GSK Investigational Site - Asheville
- GSK Investigational Site - Fayetteville
Virginia
- GSK Investigational Site - Annandale
- GSK Investigational Site - Norfolk
Other
- GSK Investigational Site - Brussels
- GSK Investigational Site - Liège
Alabama
- GSK Investigational Site - Dothan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 286 participants |
| Start Date | 2012-08-01 |
| Est. Completion | 2014-07-16 |
| Phase | Phase 2 |
What the finished NCT01648140 record still lists
NCT01648140 is an interventional study that assigns participants to a tested intervention. The registered 286 participants enrollment target is mid-sized for trials with a published cap, below the 365-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (22% lower).
The record links to 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 5 interventions - of which Ribavirin is the first listed.
NCT01648140 names 20 study sites across 13 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT01648140 about?
NCT01648140 is a clinical study titled "Dose Ranging of GSK2336805 in Combination Therapy". 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...
What is the current status of trial NCT01648140?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 286 participants. The study started on 2012-08-01. Estimated completion is 2014-07-16.
What conditions does trial NCT01648140 study?
This clinical trial studies the following conditions: Hepatitis C, Chronic.
What interventions are being tested in trial NCT01648140?
The interventions under investigation include: Ribavirin (DRUG), Telaprevir (DRUG), GSK2336805 40 mg (DRUG), GSK2336805 60 mg (DRUG), Pegylated interferon alpha-2a (DRUG).
Who is sponsoring clinical trial NCT01648140?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01648140 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis C, Chronic
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01648140's enrollment target sits among peer trials
286 7th of 26 higher than 20 of 26 other Hepatitis C, Chronic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C, Chronic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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