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Expanded Access of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory ITP

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ClinicalTrials.gov Identifier: NCT03363334
Expanded Access Status : No longer available
First Posted : December 6, 2017
Last Update Posted : August 1, 2018
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Brief Summary:
C-935788-055 is an open-label, multi-center, expanded access (EAP) study.

Condition or disease Intervention/treatment
Immune Thrombocytopenic Purpura Drug: Fostamatinib disodium 100 mg Drug: Fostamatinib disodium 150 mg

Detailed Description:
The purpose of the program is to provide Fostamatinib in an Expanded Access setting to subjects who meet the selection criteria.

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Study Type : Expanded Access
Expanded Access Type : Intermediate-size Population
Official Title: Expanded Access (Compassionate Use) of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory Immune Thrombocytopenic Purpura (ITP)



Intervention Details:
  • Drug: Fostamatinib disodium 100 mg
    Fostamatinib Disodium tablet 100 mg PO bid (morning and evening)
    Other Names:
    • Fostamatinib
    • R935788
    • R788
  • Drug: Fostamatinib disodium 150 mg
    Fostamatinib Disodium tablet 150 mg PO bid (morning and evening)
    Other Names:
    • Fostamatinib
    • R935788
    • R788

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Adult patient with chronic or persistent ITP.
  2. Must have failed or are unable to receive standard of care treatments for ITP.
  3. Must have at least two platelet counts < 30,000/µL during the last 2 months prior to screen date.

Exclusion Criteria:

  1. ITP associated with lymphoma, chronic lymphocytic leukemia, transplant, or thrombocytopenia associated with myeloid dysplasia.
  2. Subject has uncontrolled or poorly controlled hypertension.
  3. Any of the following laboratory abnormalities: neutrophil count of < 1,500/µL, or transaminase levels (ALT, AST) > 1.5x ULN, total bilirubin > 2.0 mg/dL.
  4. Active HBV or HCV infection.
  5. Current or recent enrollment in an investigational drug or device study.

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): NCT03363334


Sponsors and Collaborators
Rigel Pharmaceuticals
Investigators
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Study Director: Anne-Marie Duliege, M.D. Rigel Pharmaceuticals, Inc., Chief Medical Officer

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Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03363334     History of Changes
Other Study ID Numbers: C-935788-055
First Posted: December 6, 2017    Key Record Dates
Last Update Posted: August 1, 2018
Last Verified: June 2018

Keywords provided by Rigel Pharmaceuticals:
ITP
Immune Thrombocytopenia

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