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

NCT02076412 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2019-01-25

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 Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.

DRUG

Placebo

Placebo tablet PO bid (morning and evening)

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
2015-01-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States
  • Austria
  • Bulgaria
  • Czechia
  • Germany
  • Norway
  • Poland
  • Romania
  • Spain

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 NCT02076412 on ClinicalTrials.gov