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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 : Active, not recruiting
First Posted : October 25, 2019
Last Update Posted : September 28, 2020
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Brief Summary:

The primary objectives of this study are:

  • To establish the efficacy of fostamatinib in placebo crossover subjects with warm antibody autoimmune hemolytic anemia (wAIHA)
  • To determine the ability to maintain a response in subjects receiving fostamatinib for wAIHA

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 : 80 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 : December 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: Fostamatinib

Subjects who at any time during the C-935788-057 study achieved a hemoglobin response in the absence of rescue in the previous 4 weeks or a steroid dose greater than baseline will continue at their current dose (100mg or 150 mg) and regimen in the extension 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 (100mg PO bid or 150 mg PO bid)

The dose may be reduced at any time to a dose as low as fostamatinib 100 mg PO qd or matching placebo if dose limiting adverse events are observed.

Other Names:
  • R935788
  • Fostamatinib




Primary Outcome Measures :
  1. Durable Response [ Time Frame: 104 weeks ]
    A primary efficacy endpoint is the proportion of subjects who achieve a durable hemoglobin response.

  2. Durable Response and Hemoglobin Response [ Time Frame: 104 weeks ]
    The proportion of any subjects who achieve a durable response and have a hemoglobin response at 48 weeks of exposure


Secondary Outcome Measures :
  1. Hemoglobin Response by Week 24 [ Time Frame: 24 weeks ]
    Proportion of placebo crossover subjects who have achieved a hemoglobin response by week 24 of this study

  2. Partial Hemoglobin Response [ Time Frame: 24 Weeks ]
    The proportion of any subjects who achieve a partial hemoglobin response

  3. Median Hemoglobin Value at Week 24 [ Time Frame: 24 weeks ]
    Median hemoglobin value at week 24 of this study, for placebo crossover subjects

  4. Median change from baseline in hemoglobin at week 24 [ Time Frame: 24 Weeks ]
    Median change from baseline in hemoglobin at week 24 of this study for placebo crossover subjects

  5. Durable Response and Maintain a Hemoglobin Response at 24 and 36 Weeks [ Time Frame: 36 Weeks ]
    The proportion of any subjects who achieve a durable response and maintain a hemoglobin response at 24 and 36 weeks of exposure



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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United States, California
University of Southern California
Los Angeles, California, United States, 90033
United States, Maryland
John Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89169
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Australia, Queensland
Cancer Trials Unit
Brisbane, Queensland, Australia, 4201
Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Austria
Hanusch-Krankenhaus
Vienna, Austria, 1140
Belgium
AZ Nikolaas
Sint-Niklaas, Belgium, 9100
Czechia
Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika
Brno, Czechia, 625 00
Fakultni nemocnice Ostrava Klinika hematoonkologie
Ostrava, Czechia, 70852
France
CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses
Pessac, France, 33603
Georgia
LTD Multiprofile Clinic Consilium Medulla
Tbilisi, Georgia, 0186
M. Zodelava Hematology Centre, Tbilisi
Tbilisi, Georgia, 0186
Germany
Universitätsklinikum Essen
Essen, Germany, 45147
Italy
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia
Milano, Italy, 20122
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: September 28, 2020
Last Verified: October 2019
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