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

NCT03764618 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2023-05-25

Study results available
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Summary

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

Conditions

  • Warm Antibody Autoimmune Hemolytic Anemia

Interventions

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.

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Rigel Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-24
Primary Completion
2022-04-11
Completion
2022-04-11
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs

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 NCT03764618 on ClinicalTrials.gov