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OpenTrials
Completed

NCT Number: NCT02612558

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

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

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Key information

Conditions

Warm Antibody Autoimmune Hemolytic Anemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alberta Hospital, Edmonton, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fostamatinib 150 mg bid

Drug

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 outcomes

  1. Hemoglobin response

    Time frame: by Week 24

    Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin

Sponsors and collaborators

Lead sponsor

Rigel Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: SOAR

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Nov 24, 2015
Registry last updated
Jul 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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