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SB497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Thrombocytopenia Due To Hepatitis C
NCT00110799 · View on ClinicalTrials.gov ↗
Study Summary
SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 as a treatment for patients with chronic hepatitis C-related thrombocytopenia who are potential candidates for antiviral treatment with pegylated interferon and ribavirin. The study will be conducted in two phases, Parts 1 and 2. In Part 1, study subjects will be randomized to 4 weeks of SB-497115-GR or placebo administered daily without antiviral therapy. Subjects who successfully complete Part 1 (platelet count 70,000/µL for Pegasys and platelet count 100,000/µL for PEG-Intron) will then proceed to Part 2. In Part 2, subjects will receive an additional 8 weeks of SB-497115-GR or placebo administered daily with antiviral therapy.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG SB497115
Study Locations (20)
Other
- GSK Investigational Site — Clermont Ferrand Cédex 1
- GSK Investigational Site — Clichy
- GSK Investigational Site — Lyon
- GSK Investigational Site — Lyon
- GSK Investigational Site — Marseille
- GSK Investigational Site — Nice
- GSK Investigational Site — Paris
- GSK Investigational Site — Pessac
- GSK Investigational Site — Vandœuvre-lès-Nancy
Virginia
- GSK Investigational Site — Fairfax
- GSK Investigational Site — Richmond
Colorado
- GSK Investigational Site — Denver
Massachusetts
- GSK Investigational Site — Boston
Michigan
- GSK Investigational Site — Detroit
Missouri
- GSK Investigational Site — St Louis
New York
- GSK Investigational Site — New York
North Carolina
- GSK Investigational Site — Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2005-04 |
| Est. Completion | 2006-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00110799
The ClinicalTrials.gov registry entry for NCT00110799 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 75 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 3 conditions, with Hepatitis C appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT00110799 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Other, Virginia, Colorado. 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 NCT00110799 about?
NCT00110799 is a clinical study titled "SB497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Thrombocytopenia Due To Hepatitis C". SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 as a treatment for patients with chronic hepatitis C-related thrombocytopenia who are potential candidates for antivi...
What is the current status of trial NCT00110799?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2005-04. Estimated completion is 2006-11.
What conditions does trial NCT00110799 study?
This clinical trial studies the following conditions: Hepatitis C, Hepatitis C, Chronic, Thrombocytopenia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00110799?
The interventions under investigation include: Placebo (OTHER), SB497115 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00110799?
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 NCT00110799 being conducted?
This trial has 20 study locations across Colorado, Massachusetts, Michigan, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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