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

July 30, 2018 updated by: Rigel Pharmaceuticals

Expanded Access (Compassionate Use) of Fostamatinib in Patients With Persistent or Chronic Relapsing/Refractory Immune Thrombocytopenic Purpura (ITP)

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

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Expanded Access

Expanded Access Type

  • Intermediate-size Population

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigel Pharmaceuticals

Investigators

  • Study Director: Anne-Marie Duliege, M.D., Rigel Pharmaceuticals, Inc., Chief Medical Officer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

November 28, 2017

First Submitted That Met QC Criteria

November 30, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-935788-055

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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