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

Part of paid clinical trials in Nyack, New York.

Sponsor
Rigel Pharmaceuticals
Study ID
NCT02076412
Phase
PHASE3
Status
Completed

Conditions

  • Immune Thrombocytopenic Purpura

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Jan 31, 2015
Status verified
Jan 2019
Primary completion
Aug 31, 2016
Completion
Aug 31, 2016

Study Design

Enrollment
74 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fostamatinib Disodium
    Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
  • Other: Placebo
    Placebo tablet PO bid (morning and evening) over the course of 24 weeks

Primary Outcome Measure

Number of Participants With Stable Platelet Response of at Least 50,000/µL [ Time Frame: Baseline to Week 24 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hematology Oncology Associates of Rockland Division of Highland Medical PCNyackNew York10960-

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By research site
Hematology Oncology Associates of Rockland Division of Highland Medical PC· Nyack, NY

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