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

NCT04138927 | Enrolling By Invitation Phase 3 DMC FDA Drug

• 1 other identifier: C-935788-058
• Study Type: interventional
• Target: 90
• Locations: 16 countries
• Sites: 33

Brief 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

Keywords

wAIHA; Warm Antibody Autoimmune Hemolytic Anemia; Warm Autoimmune Hemolytic Anemia

Outcome Measures

Primary Outcomes (3)

• Adverse Events

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

  104 weeks

• Blood Pressure

  Change from baseline in blood pressure over time

  104 weeks

• Absolute Neutrophil Count (ANC)

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

  104 weeks

Secondary Outcomes (3)

• Achievement of Durable Hemoglobin Response

  24 weeks

• Total Duration of Response

  During the Intervention period up to 104 weeks

• Corticosteroid dose

  During the Intervention period up to 104 weeks

Study Arms (1)

Fostamatinib

EXPERIMENTAL

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.

Drug: Fostamatinib disodium

Interventions

Fostamatinib disodium DRUG

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

Also known as: R935788, Fostamatinib

Fostamatinib

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rigel Pharmaceuticals: lead

Study Sites (37)

University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory

Los Angeles, California, 90033, United States

Location

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

Lombardi Comprehensive Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

John Hopkins Bayview Medical Center

Baltimore, Maryland, 21205, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

American Oncology Network Vista Oncology Division

Olympia, Washington, 98506, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Princess Alexandra Hospital - Cancer Trials Unit

Brisbane, Queensland, 4201, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Hanusch-Krankenhaus

Vienna, 1140, Austria

Location

Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie

Vienna, A-1090, Austria

Location

Vitebsk Regional Clinical Hospital

Vitebsk, 210037, Belarus

Location

Vitebsk Regional Clinical Oncology Dispensary

Vitebsk, 210603, Belarus

Location

AZ Nikolaas

Sint-Niklaas, 9100, Belgium

Location

University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic of Medical oncology

Pleven, 5800, Bulgaria

Location

University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology

Sofia, 1431, Bulgaria

Location

Specialized Hospital for Active Treatment of Hematological Disease EAD,

Sofia, 1756, Bulgaria

Location

Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika

Brno, 625 00, Czechia

Location

Fakultni nemocnice Ostrava Klinika hematoonkologie

Ostrava, 70852, Czechia

Location

CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses

Pessac, 33603, France

Location

LTD Multiprofile Clinic Consilium Medulla

Tbilisi, 0186, Georgia

Location

M. Zodelava Hematology Centre, Tbilisi

Tbilisi, 0186, Georgia

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia

Milan, Italy

Location

Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia

Milan, 20122, Italy

Location

SCDU Ematologia AOU "Maggiore della Carità"

Novara, 28100, Italy

Location

Academisch Medisch Centrum

Amsterdam, Netherlands

Location

Haukeland University Hospital

Bergen, 5021, Norway

Location

National Research Center for Hematology

Moscow, 125167, Russia

Location

State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory

Sochi, 354057, Russia

Location

Clinical Centre of Vojvodina, Clinic for Hematology

Novi Sad, 21000, Serbia

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

City Clinical Hospital № 4, Hematology Center

Dnipro, 49102, Ukraine

Location

Kyiv City Clinical Hospital №9, hematology department №1

Kyiv, 04112, Ukraine

Location

Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust

Liverpool, L7 8XP, United Kingdom

Location

MeSH Terms

Interventions

fostamatinib

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: October 30, 2019
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 17, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1); GB (1); IT (3); FR (1); BE (1); NL (1); BU (3); AU (2); UA (2); GE (2); DE (1); SE (1); CZ (2); US (8); RU (2); ES (2)