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

Conditions

• Warm Antibody Autoimmune Hemolytic Anemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Fostamatinib disodium — DRUG
  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.
• Placebo — DRUG
  Placebo

Study Details

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

Key Dates

Start date

Apr 24, 2019

Status verified

May 2023

Primary completion

Apr 11, 2022

Completion

Apr 11, 2022

Study Design

Enrollment

90 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Fostamatinib
  Initial dose is 100 mg by mouth (PO) twice a day (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.
• Placebo Comparator: Placebo
  Initial dose is 100 mg by mouth (PO) twice a day (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.

Primary Outcome Measure

Durable Hemoglobin Response [ Time Frame: 24 Weeks ]

Locations (26)

Find similar trials in Gilbert, AZ

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• A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
  PHASE3 · Enrolling By Invitation · Rigel Pharmaceuticals · Los Angeles, California