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

NCT04138927 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-03-17

No results posted yet for this study

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).

Conditions

  • Warm Antibody Autoimmune Hemolytic Anemia

Interventions

DRUG

Fostamatinib disodium

Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.

Sponsors & Collaborators

  • Rigel Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-30
Primary Completion
2024-04-30
Completion
2024-04-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Belarus
  • Belgium
  • Bulgaria
  • Czechia
  • France
  • Georgia
  • Germany
  • Italy
  • Netherlands
  • Norway
  • Russia
  • Serbia
  • Spain
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04138927 on ClinicalTrials.gov