SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adults With Refractory Immune Thrombocytopenic Purpura (ITP)

April 11, 2013 updated by: GlaxoSmithKline

See Detailed Description

This study is a double-blind, randomized, placebo-controlled, parallel group, repeat-dose, study conducted in two parts (Part A and Part B) examining 30, 50, and 75 mg doses of SB-497115-GR as a treatment for patients with ITP who have failed prior therapy. The study is designed to determine the proportion of patients with a platelet count =50,000/µL after 42 days. In Part B, 99 newly-recruited subjects will be randomized to one of two dosing arms in a 2:1 ratio of active:placebo. During the 6 week study period, subjects will start on placebo or active drug (50 mg) and may have a dose increase to 75 mg based upon their platelet count at day 22.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A double-blind, randomized, placebo-controlled, parallel group study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of SB-497119-GR, a thrombopoietin receptor agonist, administered at 30, 50, and 75 mg as oral tablets once-daily for 6 weeks to adult male and female subjects with refractory, chronic immune thrombocytopenia purpura

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Bad Nauheim, Hessen, Germany, 61231
        • GSK Investigational Site
  • Greece
      • Athens, Greece, 10676
        • GSK Investigational Site
      • Athens, Greece
        • GSK Investigational Site
      • Thessaloniki, Greece, 57010
        • GSK Investigational Site
  • Hong Kong
      • Pokfulam, Hong Kong
        • GSK Investigational Site
      • Shatin, Hong Kong
        • GSK Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 136-705
        • GSK Investigational Site
      • Seoul, Korea, Republic of, 140-743
        • GSK Investigational Site
  • New Zealand
      • Auckland, New Zealand, 1701
        • GSK Investigational Site
  • Pakistan
      • Lahore, Pakistan, 54600
        • GSK Investigational Site
  • Poland
      • Lodz, Poland, 93-510
        • GSK Investigational Site
  • Romania
      • Bucharest, Romania, 022328
        • GSK Investigational Site
      • Bucharest, Romania, 050098
        • GSK Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 105 229
        • GSK Investigational Site
      • Moscow, Russian Federation, 125167
        • GSK Investigational Site
      • Novosibirsk, Russian Federation, 630087
        • GSK Investigational Site
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • GSK Investigational Site
      • Maribor, Slovenia, 2000
        • GSK Investigational Site
  • Taiwan
      • Taipei, Taiwan, 114
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10330
        • GSK Investigational Site
      • ChiangMai, Thailand, 50000
        • GSK Investigational Site
      • Khon Kaen, Thailand, 40002
        • GSK Investigational Site
  • United Kingdom
      • Liverpool, United Kingdom, L7 8XP
        • GSK Investigational Site
      • London, United Kingdom, E1 1BB
        • GSK Investigational Site
      • London, United Kingdom, WC1E 6HX
        • GSK Investigational Site
      • Manchester, United Kingdom, M13 9WL
        • GSK Investigational Site
      • Swansea, United Kingdom, SA6 6NL
        • GSK Investigational Site
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG1 7AN
        • GSK Investigational Site
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • Patients with chronic low platelet count (less than 30,000/µL) for 6 months who have failed at least one treatment for chronic low platelet count.
  • Patients receiving chronic maintenance steroid therapy must have received a stable dose for at least 1 month.
  • Normal PT and PTT.

Exclusion criteria:

  • History of clotting disorder.
  • Females who are pregnant or are receiving hormone replacement therapy or systemic contraceptives.
  • History of alcohol/drug abuse or dependence within 1 year.
  • Use of aspirin, aspirin-containing compounds, salicylates, antacids, rosuvastatin, pravastatin, non-steroidal anti-inflammatory drugs during the study and within 3 weeks prior to starting the study.
  • History of HIV infection or active infection with Hepatitis B or C.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Treatment response, assessed by the proportion of patients with platelet counts of =50, 000/µL (compared with baseline count of <30, 000/µL) after 42 days of treatment.

Secondary Outcome Measures

Outcome Measure
Safety, tolerability, PK, PD, symptoms associated with ITP, and QoL, odds of response vs placebo during weeks 2 to 6 of the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

February 1, 2005

First Submitted That Met QC Criteria

February 1, 2005

First Posted (Estimate)

February 2, 2005

Study Record Updates

Last Update Posted (Estimate)

April 15, 2013

Last Update Submitted That Met QC Criteria

April 11, 2013

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRA100773

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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