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A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA) (SOAR)

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ClinicalTrials.gov Identifier: NCT02612558
Recruitment Status : Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : September 5, 2018
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Brief Summary:
The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).

Condition or disease Intervention/treatment Phase
Warm Antibody Autoimmune Hemolytic Anemia Drug: Fostamatinib 150 mg bid Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multi-Center, Open Label, Simon Two-Stage Study to Evaluate the Safety and Efficacy of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Actual Study Start Date : July 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019


Arm Intervention/treatment
Experimental: Fostamatinib 150 mg
Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks
Drug: Fostamatinib 150 mg bid
Fostamatinib 150 mg bid. The dose of Fostamatinib may be reduced at any time to as low as 100 mg PO once daily (qd) if dose limiting adverse events are observed.
Other Names:
  • R935788
  • R788
  • Fostamatinib
  • Tavalisse




Primary Outcome Measures :
  1. Hemoglobin response [ Time Frame: by Week 24 ]
    Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin



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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subject must have had a diagnosis of primary or secondary warm antibody AIHA.

- Must have failed at least 1 prior treatment regimen for AIHA.

Exclusion Criteria:

  • Subject with cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria.
  • Subject with a platelet count of < 30,000/μL.
  • Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosis (SLE), or lymphoid malignancy and the underlying disease is not stable or is not well-controlled on current therapy.
  • Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥ 130 mmHg, or diastolic blood pressure ≥ 80 mmHg.

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): NCT02612558


  Show 36 Study Locations
Sponsors and Collaborators
Rigel Pharmaceuticals
Investigators
Study Director: Rigel Pharmaceuticals Rigel Pharmaceuticals, Inc.

Additional Information:
Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02612558     History of Changes
Other Study ID Numbers: C-935788-053
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: September 5, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Rigel Pharmaceuticals:
Warm antibody autoimmune hemolytic anemia (AIHA)

Additional relevant MeSH terms:
Anemia
Hemolysis
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hematologic Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunoglobulins
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs