Dose Ranging of GSK2336805 in Combination Therapy
Public ClinicalTrials.gov record NCT01648140. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01648140
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 286 participants
Conditions and interventions
Conditions
Interventions
- GSK2336805 40 mg Drug
- GSK2336805 60 mg Drug
- Pegylated interferon alpha-2a Drug
- Ribavirin Drug
- Telaprevir Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 31, 2012
- Primary completion
- Jun 30, 2014
- Completion
- Jul 15, 2014
- Last update posted
- Jun 1, 2017
2012 – 2014
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Dothan | Alabama | 36305 | — |
| GSK Investigational Site | Anaheim | California | 92801 | — |
| GSK Investigational Site | Los Angeles | California | 90017 | — |
| GSK Investigational Site | DeLand | Florida | 32720 | — |
| GSK Investigational Site | Orlando | Florida | 32806 | — |
| GSK Investigational Site | Columbus | Georgia | 31904 | — |
| GSK Investigational Site | Savannah | Georgia | 31405 | — |
| GSK Investigational Site | Baltimore | Maryland | 21229 | — |
| GSK Investigational Site | Brockton | Massachusetts | 02302 | — |
| GSK Investigational Site | Springfield | Massachusetts | 01105 | — |
| GSK Investigational Site | Las Vegas | Nevada | 89109 | — |
| GSK Investigational Site | New York | New York | 10016 | — |
| GSK Investigational Site | Asheville | North Carolina | 28801 | — |
| GSK Investigational Site | Fayetteville | North Carolina | 28304 | — |
| GSK Investigational Site | Jenkintown | Pennsylvania | 19046 | — |
| GSK Investigational Site | Houston | Texas | 77074 | — |
| GSK Investigational Site | Annandale | Virginia | 22003 | — |
| GSK Investigational Site | Norfolk | Virginia | 23502 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 16 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01648140, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 1, 2017 · Synced Sep 2, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01648140 live on ClinicalTrials.gov.