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NCT00110799 · ClinicalTrials.gov registry record · Phase 2

SB497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Thrombocytopenia Due To Hepatitis C

A Phase 2 study of Hepatitis C and Hepatitis C, Chronic, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 2
Development phase
75
Enrollment target
20
Study locations

NCT00110799 is a Phase 2 study of Hepatitis C and Hepatitis C, Chronic that has completed, run by GlaxoSmithKline. The registered enrollment target is 75 participants, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT00110799, a Phase 2 study of Hepatitis C and Hepatitis C, Chronic, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 2
Development phase
75 participants
Enrollment target
20
Study locations

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

Hepatitis C Hepatitis C, Chronic Thrombocytopenia

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

FieldValue
Enrollment Target 75 participants
Start Date 2005-04
Est. Completion 2006-11
Phase Phase 2

Sponsor

GlaxoSmithKline

1,345 total trials

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What the Registry Record Tells You About NCT00110799

The ClinicalTrials.gov registry entry for NCT00110799 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (96% lower). The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

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.

NCT00110799 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, Virginia, Colorado.

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.

What interventions are being tested in trial NCT00110799?

The interventions under investigation include: Placebo (OTHER), SB497115 (DRUG).

Who is sponsoring clinical trial NCT00110799?

This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.