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OpenTrials
Enrolling by Invitation

NCT Number: NCT04138927

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

The primary objective of this study is:

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

Enrolling by Invitation

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Key information

Conditions

Warm Antibody Autoimmune Hemolytic Anemia

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Princess Alexandra Hospital - Cancer Trials Unit, Brisbane, Queensland, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Subject must have completed all 24 weeks of participation in the study C-935788-057.

Exclusion criteria

  • Any subject who discontinued participation in Study C-935788-057 prior to Week 24.

Treatment and study plan

Fostamatinib disodium

Drug

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

Other names: R935788, Fostamatinib

Primary outcomes

  1. Adverse Events

    Time frame: 104 weeks

    Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study

  2. Blood Pressure

    Time frame: 104 weeks

    Change from baseline in blood pressure over time

  3. Absolute Neutrophil Count (ANC)

    Time frame: 104 weeks

    Change from baseline in absolute neutrophil count (ANC) over time

Secondary outcomes

  1. Achievement of Durable Hemoglobin Response

    Time frame: 24 weeks

  2. Total Duration of Response

    Time frame: During the Intervention period up to 104 weeks

  3. Corticosteroid dose

    Time frame: During the Intervention period up to 104 weeks

    Net cumulative change from Baseline in corticosteroid dose

Sponsors and collaborators

Lead sponsor

Rigel Pharmaceuticals

Industry

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 25, 2019
Registry last updated
Mar 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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