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A Efficacy and Safety Study of R935788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

NCT02076399 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2019-02-12

Study results available
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Summary

The purpose of this study is to determine whether fostamatinib is safe and effective in the treatment of persistent/chronic Immune Thrombocytopenic Purpura (ITP).

Conditions

  • Immune Thrombocytopenic Purpura

Interventions

DRUG

Fostamatinib disodium

Fostamatinib (100 mg PO bid or 150 mg PO bid)

DRUG

Placebo

Placebo tablet PO bid (morning and evening) over the course of 24 weeks

Sponsors & Collaborators

  • Rigel Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Rigel Pharmaceuticals, Inc. · Rigel Pharmaceuticals,Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-14
Primary Completion
2016-04-21
Completion
2016-04-21

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • Hungary
  • Italy
  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

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 NCT02076399 on ClinicalTrials.gov