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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 : March 17, 2022
Sponsor:
Information provided by (Responsible Party):
Rigel Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE October 23, 2019
First Posted Date  ICMJE October 25, 2019
Last Update Posted Date March 17, 2022
Actual Study Start Date  ICMJE October 30, 2019
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2021)
  • Adverse Events [ Time Frame: 104 weeks ]
    Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
  • Blood Pressure [ Time Frame: 104 weeks ]
    Change from baseline in blood pressure over time
  • Absolute Neutrophil Count (ANC) [ Time Frame: 104 weeks ]
    Change from baseline in absolute neutrophil count (ANC) over time
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • Durable Response [ Time Frame: 104 weeks ]
    A primary efficacy endpoint is the proportion of subjects who achieve a durable hemoglobin response.
  • 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2021)
  • Achievement of Durable Hemoglobin Response [ Time Frame: 24 weeks ]
  • Total Duration of Response [ Time Frame: During the Intervention period up to 104 weeks ]
  • Corticosteroid dose [ Time Frame: During the Intervention period up to 104 weeks ]
    Net cumulative change from Baseline in corticosteroid dose
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • 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
  • Partial Hemoglobin Response [ Time Frame: 24 Weeks ]
    The proportion of any subjects who achieve a partial hemoglobin response
  • Median Hemoglobin Value at Week 24 [ Time Frame: 24 weeks ]
    Median hemoglobin value at week 24 of this study, for placebo crossover subjects
  • 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
  • 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Official Title  ICMJE A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Brief Summary

The primary objective of this study is:

• To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Warm Antibody Autoimmune Hemolytic Anemia
Intervention  ICMJE Drug: Fostamatinib disodium
Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.
Other Names:
  • R935788
  • Fostamatinib
Study Arms  ICMJE 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.

Intervention: Drug: Fostamatinib disodium
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 Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: May 4, 2021)
90
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2019)
80
Estimated Study Completion Date  ICMJE April 2024
Estimated Primary Completion Date April 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (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 Australia,   Austria,   Belarus,   Belgium,   Bulgaria,   Czechia,   France,   Georgia,   Germany,   Italy,   Netherlands,   Norway,   Russian Federation,   Serbia,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04138927
Other Study ID Numbers  ICMJE C-935788-058
Has Data Monitoring Committee Yes
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
Current Responsible Party Rigel Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rigel Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rigel Pharmaceuticals
Verification Date July 2021

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