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

NCT03363334 | Unknown

• 1 other identifier: C-935788-055
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Immune Thrombocytopenic Purpura

Keywords

ITP; Immune Thrombocytopenia

Interventions

Fostamatinib disodium 100 mg DRUG

Fostamatinib Disodium tablet 100 mg PO bid (morning and evening)

Also known as: Fostamatinib, R935788, R788

Fostamatinib disodium 150 mg DRUG

Fostamatinib Disodium tablet 150 mg PO bid (morning and evening)

Also known as: Fostamatinib, R935788, R788

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ITP associated with lymphoma, chronic lymphocytic leukemia, transplant, or thrombocytopenia associated with myeloid dysplasia.
• Subject has uncontrolled or poorly controlled hypertension.
• 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.
• Active HBV or HCV infection.
• Current or recent enrollment in an investigational drug or device study.

Sponsors & Collaborators

• Rigel Pharmaceuticals: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Anne-Marie Duliege, M.D.

  Rigel Pharmaceuticals, Inc., Chief Medical Officer

  STUDY DIRECTOR

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 6, 2017
• Last Updated: August 1, 2018

Record last verified: 2018-06