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

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ClinicalTrials.gov Identifier: NCT02076412
Recruitment Status : Completed
First Posted : March 3, 2014
Last Update Posted : August 22, 2017
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Brief 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).

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenic Purpura Drug: Fostamatinib Disodium 100mg Drug: Placebo Drug: Fostamatinib Disodium 150mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
Study Start Date : November 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016


Arm Intervention/treatment
Active Comparator: Fostamatinib Disodium 100mg
Fostamatinib Disodium tablet 100 mg PO bid (morning and evening) over the course of 24 weeks
Drug: Fostamatinib Disodium 100mg
Fostamatinib Disodium tablet 100 mg PO bid (morning and evening) over the course of 24 weeks.
Other Names:
  • R935788
  • R788
  • Fostamatinib

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

Active Comparator: Fostamatinib Disodium 150mg
Fostamatinib Disodium tablet 150 mg PO bid (morning and evening) over the course of 24 weeks
Drug: Fostamatinib Disodium 150mg
Fostamatinib Disodium tablet 150 mg PO bid (morning and evening) over the course of 24 weeks.
Other Names:
  • R935788
  • R788
  • Fostamatinib




Primary Outcome Measures :
  1. Stable platelet response of at least 50,000/µL [ Time Frame: Baseline to Week 24 ]
    Stable platelet response by Week 24 defined as a platelet count of at least 50,000/µL on at least 4 of the 6 visits between Weeks 14-24



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of persistent/chronic ITP for at least 3 months
  • Average platelet count< 30,000/µL (and none > 35,000 unless as a result of rescue therapy) from at least 3 qualifying counts

Exclusion Criteria:

  • Clinical diagnosis of autoimmune hemolytic anemia
  • Uncontrolled or poorly controlled hypertension
  • History of coagulopathy including prothrombotic conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02076412


  Show 35 Study Locations
Sponsors and Collaborators
Rigel Pharmaceuticals
Investigators
Study Director: Rigel Pharmaceuticals, Inc. Rigel Pharmaceuticals, Inc.

Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02076412     History of Changes
Other Study ID Numbers: C-935788-048
2013-005453-76 ( EudraCT Number )
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: August 22, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Thrombocytopenia
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases