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Trial record 1 of 1 for:    02077192
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Open Label Study of R788 in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura (ITP)

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ClinicalTrials.gov Identifier: NCT02077192
Recruitment Status : Active, not recruiting
First Posted : March 4, 2014
Last Update Posted : June 27, 2018
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 treating patients with persistent/chronic Immune Thrombocytopenic Purpura (ITP) over a 5 year period.

Condition or disease Intervention/treatment Phase
Immune Thrombocytopenic Purpura Drug: Fostamatinib Disodium Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Persistent/Chronic Immune Thrombocytopenic Purpura
Study Start Date : July 2014
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020


Arm Intervention/treatment
Experimental: Fostamatinib Disodium
Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
Drug: Fostamatinib Disodium
Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
Other Names:
  • R935788
  • R788
  • Fostamatinib




Primary Outcome Measures :
  1. Number of Participants with platelet count of at least 50,000/µL as a Measure of Safety and Efficacy [ Time Frame: 5 years ]


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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:

  • Completed week 24 evaluation of Study C935788-047 or Study C935788-048 or discontinued early due to lack of response.
  • Able and willing to give written informed consent

Exclusion Criteria:

  • Discontinued participation in Study C935788-047 or Study C935788-048 for any reason other than lack of response
  • Poorly controlled hypertension during Study C935788-047 or Study C935788-048
  • Significant infection, an acute infection such as influenza, or known inflammatory process

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): NCT02077192


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

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Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02077192     History of Changes
Other Study ID Numbers: C-935788-049
2013-005454-30 ( EudraCT Number )
First Posted: March 4, 2014    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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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