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

Conditions

• Warm Antibody Autoimmune Hemolytic Anemia

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

The primary objective of this study is: • To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).

Key Dates

Start date

Oct 30, 2019

Status verified

Jul 2021

Primary completion

Apr 30, 2024

Completion

Apr 30, 2024

Study Design

Enrollment

90 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• 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.

Primary Outcome Measure

Adverse Events [ Time Frame: 104 weeks ]

Locations (8)

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