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A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia

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: NCT04138927
Recruitment Status : Enrolling by invitation
First Posted : October 25, 2019
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Brief Summary:

The primary objective of this study is:

• To evaluate the long-term safety of fostamatinib

The secondary objectives are:

  • To compare the proportion of subjects with wAIHA who achieve a durable hemoglobin response
  • To estimate the durability of response in subjects receiving fostamatinib for wAIHA To assess steroid use in subjects with wAIHA treated with fostamatinib.

Condition or disease Intervention/treatment Phase
Warm Antibody Autoimmune Hemolytic Anemia Drug: Fostamatinib disodium Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Actual Study Start Date : October 30, 2019
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024


Arm Intervention/treatment
Experimental: Fostamatinib

Subjects who at any time during the C-935788-057 study achieved a hemoglobin response will continue at their dose and regimen from the Week 22 visit in the C-935788-057 study.

All other subjects who enter the extension study will initially receive fostamatinib 100 mg PO bid. Starting at Week 4, the initial fostamatinib dose of 100 mg PO bid will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug, based on the Investigator's judgment.

Drug: Fostamatinib disodium
Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.
Other Names:
  • R935788
  • Fostamatinib




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 104 weeks ]
    Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study

  2. Blood Pressure [ Time Frame: 104 weeks ]
    Change from baseline in blood pressure over time

  3. Absolute Neutrophil Count (ANC) [ Time Frame: 104 weeks ]
    Change from baseline in absolute neutrophil count (ANC) over time


Secondary Outcome Measures :
  1. Achievement of Durable Hemoglobin Response [ Time Frame: 24 weeks ]
  2. Total Duration of Response [ Time Frame: During the Intervention period up to 104 weeks ]
  3. Corticosteroid dose [ Time Frame: During the Intervention period up to 104 weeks ]
    Net cumulative change from Baseline in corticosteroid dose



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject must be willing and able to give written informed consent by signing an IRB approved Informed Consent Form prior to undergoing any study-specific procedures.
  2. Subject must have completed all 24 weeks of participation in the study C-935788-057.

Exclusion Criteria:

1. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.


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): NCT04138927


Locations
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Sponsors and Collaborators
Rigel Pharmaceuticals
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Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04138927    
Other Study ID Numbers: C-935788-058
First Posted: October 25, 2019    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rigel Pharmaceuticals:
wAIHA
Warm Antibody Autoimmune Hemolytic Anemia
Warm Autoimmune Hemolytic Anemia
Additional relevant MeSH terms:
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Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hemolysis
Hematologic Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases