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

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Rigel Pharmaceuticals

Status and phase

Completed
Phase 2

Conditions

Warm Antibody Autoimmune Hemolytic Anemia

Treatments

Drug: Fostamatinib 150 mg bid

Study type

Interventional

Funder types

Industry

Identifiers

NCT02612558
C-935788-053

Details and patient eligibility

About

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

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

26 participants in 1 patient group

Fostamatinib 150 mg
Experimental group
Description:
Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks
Treatment:
Drug: Fostamatinib 150 mg bid

Trial contacts and locations

36

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Data sourced from clinicaltrials.gov

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