Warm Antibody Autoimmune Hemolytic AnemiaPhase 3NCT04138927
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
A Phase 3 study testing Fostamatinib disodium in people with Warm Antibody Autoimmune Hemolytic Anemia, run by Rigel Pharmaceuticals at 37 sites in 18 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Warm Antibody Autoimmune Hemolytic Anemia
- What is being tested?
- Fostamatinib disodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 37 sitesin 18 countries
- Study dates
- 30 Oct 2019to Apr 2024
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.
Trial locations and contacts
37 sites in 18 countries. Contact the study team or a site near you to ask about taking part.
37 sites in 18 countries
United States8 sites
John Hopkins Bayview Medical Center
Baltimore, Maryland, 21205
Massachusetts General Hospital
Boston, Massachusetts, 02114
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89169
University of Southern California - Janice and Robert Hall Clinical Trials Biospecimen Laboratory
Los Angeles, California, 90033
American Oncology Network Vista Oncology Division
Olympia, Washington, 98506
University of Washington
Seattle, Washington, 98109
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502
Lombardi Comprehensive Cancer Center
Washington D.C., District of Columbia, 20007
Bulgaria3 sites
University Multiprofile Hospital for Active Treatment "Sveti Georgi" EAD, Plovdiv, Clinic of Medical oncology
Pleven, 5800
University Multiprofile Hospital for Active Treatment Sv. Ivan Rilski EAD, Varna, Clinic of Clinical Haematology
Sofia, 1431
Specialized Hospital for Active Treatment of Hematological Disease EAD,
Sofia, 1756
Italy3 sites
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, UO Ematologia
Milan
Fondazione IRCCS Ca'Granda - Ospedale Maggiore Policlinico di Milano - UO Ematologia
Milan, 20122
SCDU Ematologia AOU "Maggiore della Carità"
Novara, 28100
Australia2 sites
Princess Alexandra Hospital - Cancer Trials Unit
Brisbane, Queensland, 4201
The Alfred Hospital
Melbourne, Victoria, 3004
Austria2 sites
Hanusch-Krankenhaus
Vienna, 1140
Universitätsklinik f. Innere Medizin I - Klin. Abt. f. Hämatologie u. Hämostaseologie
Vienna, A-1090
Belarus2 sites
Vitebsk Regional Clinical Hospital
Vitebsk, 210037
Vitebsk Regional Clinical Oncology Dispensary
Vitebsk, 210603
Czechia2 sites
Fakultni nemocnice Brno Interni hematologicka a onkologicka klinika
Brno, 625 00
Fakultni nemocnice Ostrava Klinika hematoonkologie
Ostrava, 70852
Georgia2 sites
LTD Multiprofile Clinic Consilium Medulla
Tbilisi, 0186
M. Zodelava Hematology Centre, Tbilisi
Tbilisi, 0186
Russia2 sites
National Research Center for Hematology
Moscow, 125167
State Budgetary Healthcare Institution Oncology Dispensary No. 2 of the Ministry of Health of the Krasnodar Territory
Sochi, 354057
Spain2 sites
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Ukraine2 sites
City Clinical Hospital № 4, Hematology Center
Dnipro, 49102
Kyiv City Clinical Hospital №9, hematology department №1
Kyiv, 04112
France1 site
CHU de Bordeaux - GH Sud- Hôpital Haut Lévêque Service Médecine Interne et Maladies Infectieuses
Pessac, 33603
Serbia1 site
Clinical Centre of Vojvodina, Clinic for Hematology
Novi Sad, 21000
United Kingdom1 site
Roald Dahl Haemostasis and Thrombosis Centre, Royal Liverpool University Hospital, Liverpool University Hospitals NHS Foundation Trust
Liverpool, L7 8XP
About this study
The primary objective of this study is:
- To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
- Being tested
- Fostamatinib disodium
- Keywords
- wAIHA, Warm Antibody Autoimmune Hemolytic Anemia, Warm Autoimmune Hemolytic Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fostamatinib disodiumDrug
Also called R935788, Fostamatinib
Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Fostamatinib disodium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
Measured: 104 weeks
Blood Pressure
Change from baseline in blood pressure over time
Measured: 104 weeks
Absolute Neutrophil Count (ANC)
Change from baseline in absolute neutrophil count (ANC) over time
Measured: 104 weeks
Secondary outcomes (3)
Achievement of Durable Hemoglobin Response
Measured: 24 weeks
Total Duration of Response
Measured: During the Intervention period up to 104 weeks
Corticosteroid dose
Net cumulative change from Baseline in corticosteroid dose
Measured: During the Intervention period up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start30 Oct 2019
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Warm Antibody Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rigel Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04138927
- Sponsor's protocol ID
- C-935788-058
- Status last verified
- Jul 2021
- First submitted
- 23 Oct 2019
- Last updated
- 17 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
- ClinicalTrials.gov ID
- NCT04138927
- Acronym / sponsor ID
- C-935788-058
- Keywords
- wAIHA, Warm Antibody Autoimmune Hemolytic Anemia, Warm Autoimmune Hemolytic Anemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Rigel PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 25 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is:
- To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fostamatinib | Experimental | Drug: Fostamatinib disodiumSubjects 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Any subject who discontinued participation in Study C-935788-057 prior to Week 24.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fostamatinib disodiumAlso: R935788, FostamatinibFostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg. | Drug | Fostamatinib |
Primary outcome
Adverse Events
Time frame: 104 weeks
Incidence, frequency, seriousness, and severity of adverse events that occurred during the current study
Blood Pressure
Time frame: 104 weeks
Change from baseline in blood pressure over time
Absolute Neutrophil Count (ANC)
Time frame: 104 weeks
Change from baseline in absolute neutrophil count (ANC) over time
3 secondary outcomes
Achievement of Durable Hemoglobin Response
Time frame: 24 weeks
Total Duration of Response
Time frame: During the Intervention period up to 104 weeks
Corticosteroid dose
Time frame: During the Intervention period up to 104 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
37 sites in 18 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fostamatinib disodium in people with Warm Antibody Autoimmune Hemolytic Anemia, run by Rigel Pharmaceuticals at 37 sites in 18 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 17 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Bulgaria, Italy, Australia, Austria and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: 104 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2022.