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Dose Ranging of GSK2336805 in Combination Therapy

NCT01648140 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 286

Last updated 2017-06-02

Study results available
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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.

Conditions

  • Hepatitis C, Chronic

Interventions

DRUG

GSK2336805 40 mg

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

DRUG

GSK2336805 60 mg

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

DRUG

Pegylated interferon alpha-2a

180 microgram per 0.5 mL prefilled syringe for single use

DRUG

Ribavirin

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

DRUG

Telaprevir

375 mg film-coated tablet

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-01
Primary Completion
2014-07-01
Completion
2014-07-16

Countries

  • United States
  • Belgium
  • Bulgaria
  • France
  • Germany
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01648140 on ClinicalTrials.gov