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COMPLETED Phase 2

Dose Ranging of GSK2336805 in Combination Therapy

NCT01648140 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 286 participants
Start Date 2012-08-01
Est. Completion 2014-07-16
Phase Phase 2

Sponsor

GlaxoSmithKline

558 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01648140

The ClinicalTrials.gov registry entry for NCT01648140 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 286 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 558 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01648140 reports 20 study locations spanning 13 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01648140?

This trial is sponsored by GlaxoSmithKline, which has 558 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial