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Trial record 2 of 3 for:    rigel | Recruiting Studies

A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA

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ClinicalTrials.gov Identifier: NCT03764618
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Brief Summary:
The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Arm Intervention/treatment
Experimental: Fostamatinib
Initial dose is 100 mg PO bid. At week 4 dose will be increased to fostamatinib 150 mg PO bid if subjects have adequately tolerated the study drug in the opinion of the Investigator.
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

Placebo Comparator: Placebo
Initial dose is 100 mg PO bid. At week 4 dose will be increased to placebo 150 mg PO bid if subjects have adequately tolerated the study drug in the opinion of the Investigator.
Drug: Placebo
Placebo




Primary Outcome Measures :
  1. Durable Hemoglobin Response [ Time Frame: 24 Weeks ]
    The primary efficacy endpoint is the proportion of subjects who achieve a durable hemoglobin response.


Secondary Outcome Measures :
  1. Subjects with a hemoglobin response by Week 24 [ Time Frame: 24 weeks ]
    Proportion of subjects with a hemoglobin response by Week 24

  2. Frequency of rescue AIHA regimens used [ Time Frame: 24 weeks ]
    Average frequency of rescue AIHA regimens used

  3. Hemoglobin assessments exhibiting a hemoglobin response [ Time Frame: 24 weeks ]
    Average number of hemoglobin assessments exhibiting a hemoglobin response



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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 have a diagnosis of primary or secondary wAIHA as documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA.
  2. Have failed or not tolerated at least one prior wAIHA treatment regimen, including steroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, MMF, danazol, vincristine, ESA or splenectomy (folate, iron or other supplements do not fulfill this criterion).
  3. Have haptoglobin <LLN or total bilirubin >ULN or lactate dehydrogenase (LDH) >ULN.
  4. At screening, subject's hemoglobin level must be ≤9 g/dL OR if hemoglobin value >9 g/dL and <10 g/dL, subject must be on an allowed wAIHA treatment AND the subject must have documented symptoms related to anemia (e.g., weakness, dizziness, fatigue, shortness of breath, chest pain).
  5. Male or female at least 18 years of age at screening.
  6. Karnofsky performance status (KPS) ≥70.
  7. Subject's concurrent treatment for wAIHA may consist of no more than two of any of the following agents: azathioprine, steroids, ESAs, mycophenolate mofetil, dapsone or danazol at a stable dose

Exclusion Criteria:

  1. Subject with other types of AIHA (e.g., cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria).
  2. Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosus (SLE), or lymphoid malignancy if the underlying disease is not stable or is not well-controlled on current therapy, per investigator medical judgement.
  3. Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure ≥135 mmHg or diastolic blood pressure ≥85 mmHg, whether or not the subject is receiving anti-hypertensive treatment.
  4. Subject has one or more of the following laboratory abnormalities at screening: neutrophil count of <1,000/μL or platelet count of <30,000/μL, unless due to Evans syndrome; transaminase levels (i.e., alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) >1.5 x ULN.
  5. Has documented active hepatitis B or hepatitis C infection or HIV infection.

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): NCT03764618


Locations
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United States, Arizona
Arizona Oncology Associates, PC Recruiting
Tucson, Arizona, United States, 85711
Contact: Michael Boxer, MD    520-668-5678    stacey.kimbell@usoncology.com   
United States, California
The Oncology Institute of Hope and Innovation Recruiting
Whittier, California, United States, 90603
Contact: Richy Agajanian, MD    562-693-4477    kbettino@airesearch.us   
United States, New Jersey
Rutgers - Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Shuang Guo, MD    732-235-7115    kim.a.white@rutgers.edu   
Contact: Kim White    732-235-7115    kim.a.white@rutgers.edu   
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Irina Murakhovskaya, MD    718-430-2748    hinguyen@montefiore.org   
Contact: Hieu Nguyen Crouch         
United States, Texas
Clear Lake Specialties Recruiting
Webster, Texas, United States, 77598
Contact: Amir Salam, MD    281-316-0247    angel@omniclinicalresearch.com   
Georgia
M. Zodelava Hematology Centre, Tbilisi Recruiting
Tbilisi, Georgia, 0112
Contact: Mamia Zodelava, MD    +995 322-253-044    iro111@yahoo.co.uk   
Contact: Irine Datikashvili-David, MD       iro111@yahoo.co.uk   
LTD Multiprofile Clinic Consilium Medulla Recruiting
Tbilisi, Georgia, 0186
Contact: Magdana Betaneli, MD    +995 322-122-002    e.dolmazashvili@onco.ge   
Contact: Elene Dolmazashvili       e.dolmazashvili@onco.ge   
Sponsors and Collaborators
Rigel Pharmaceuticals

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Responsible Party: Rigel Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03764618     History of Changes
Other Study ID Numbers: C-935788-057
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: April 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
Hemolysis
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hematologic Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs