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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02612558
Recruitment Status : Active, not recruiting
First Posted : November 24, 2015
Last Update Posted : September 10, 2019
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 19, 2015
First Posted Date  ICMJE November 24, 2015
Last Update Posted Date September 10, 2019
Actual Study Start Date  ICMJE July 2016
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2018)
Hemoglobin response [ Time Frame: by Week 24 ]
Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin
Original Primary Outcome Measures  ICMJE
 (submitted: November 19, 2015)
Hemoglobin response [ Time Frame: by Week 12 ]
Hemoglobin level of > 10 g/dL and 2 g/dL higher than the baseline hemoglobin
Change History Complete list of historical versions of study NCT02612558 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Warm Antibody Autoimmune Hemolytic Anemia
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Fostamatinib 150 mg
Fostamatinib 150 mg bid (morning and evening) over the course of 24 weeks
Intervention: Drug: Fostamatinib 150 mg bid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 19, 2015)
37
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02612558
Other Study ID Numbers  ICMJE C-935788-053
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rigel Pharmaceuticals
Study Sponsor  ICMJE Rigel Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Rigel Pharmaceuticals Rigel Pharmaceuticals, Inc.
PRS Account Rigel Pharmaceuticals
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP