EUCTR2018-004774-97-GBActive, not recruitingPhase 1
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Rigel Pharmaceuticals, Inc.
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. 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.
- •2. Subject must have a diagnosis of primary or secondary wAIHA as documented by a positive direct antiglobulin test (DAT) specific for anti-IgG or anti-IgA. Eligibility may be based on a historical DAT obtained within 12 months of the screening visit from a local laboratory, provided that specific IgG or IgA positivity is documented; otherwise, this assay will be done at screening by a central laboratory.
- •3. Has failed or not tolerated at least one prior wAIHA treatment, e.g., steroids, rituximab, azathioprine, cyclophosphamide, cyclosporine, mycophenolate mofetil (MMF), danazol, vincristine, ESA or splenectomy (folate, iron or other supplements do not fulfill this criterion).
- •4. Has haptoglobin ULN or lactate dehydrogenase (LDH) >ULN.
- •5. At screening, subject’s hemoglobin level must be =9 g/dL
- •If the hemoglobin value is >9 g/dL and <10 g/dL, subject must be on an allowed wAIHA treatment (see Allowed AIHA Therapy table) AND the subject must have documented symptoms related to anemia (e.g., weakness, dizziness, fatigue, shortness of breath, chest pain).
- •6. Male or female at least 18 years of age at screening.
- •7. Karnofsky performance status (KPS) =70.
- •8. Subject’s concurrent treatment for wAIHA may consist of no more than two of any of the following agents: azathioprine, steroids, ESAs, mycophenolate mofetil, dapsone or danazol at a stable dose, as defined in the Allowed AIHA Therapies table. Subject has not taken any disallowed therapies in the intervals defined by the protocol.
- •9. Female subjects must be either post-menopausal for at least 1 year or surgically sterile; or, if of childbearing potential, must not be pregnant or lactating and must agree to use a highly effective method of birth control throughout the duration of the trial and for 30 days following the last dose. Acceptable methods of birth control are defined as: hormonal contraception (pill, injection or implant) used consistently for at least 30 days prior to screening, an intrauterine device (IUD), or intrauterine hormone-releasing system (IUS), or true abstinence (i.e. abstinence is in line with the preferred and usual lifestyle of the subject).
- •10. In the investigator’s opinion, the subject has the ability to understand the nature of the study and any hazards of participation and to communicate satisfactorily with the investigator.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 81
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Subject with other types of AIHA (e.g., cold antibody AIHA, cold agglutinin syndrome, mixed type AIHA, or paroxysmal cold hemoglobinuria).
- •2. Subject has AIHA secondary to autoimmune disease, including systemic lupus erythematosus (SLE), or lymphoid malignancy if the underlying disease is not stable or is not well-controlled on current therapy, per investigator medical judgment.
- •3. Subject has a history of or active, clinically significant, cardiovascular, respiratory, gastrointestinal, renal, hepatic, neurological, psychiatric, musculoskeletal, genitourinary, dermatological, or other disorder that, in the investigator’s opinion, could affect the conduct of the study or the absorption, metabolism or excretion of the study drug.
- •4. Subject has uncontrolled or poorly controlled hypertension, defined as systolic blood pressure =135 mmHg or diastolic blood pressure =85 mmHg, whether or not the subject is receiving anti-hypertensive treatment.
- •5. Subject has one or more of the following laboratory abnormalities at screening: neutrophil count of <1,000/µL or platelet count of <30,000/µL, unless due to Evans syndrome; transaminase levels (i.e., alanine aminotransferase [ALT] or aspartate aminotransferase [AST]) >1.5 x ULN.
- •6. Has documented HIV infection or active hepatitis B or hepatitis C infection.
- •7. Subject is currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or 5 half-lives (whichever is longer) of Day 1.
- •8. In the judgment of the investigator, the subject may not be able to fully comply with study requirements.
- •9. Subject has been treated with fostamatinib previously for any indication.
- •10. Subject has a known allergy and/or sensitivity to the test article or its components.
- •11. Subject has had a splenectomy within the past 4 weeks.
Investigators
Similar Trials
Unknown
Phase 3
SR-PAAS - Sitaxentan Efficacy and Safety Trial With a Randomized Prospective Assessment of Adding SildenafilCTRI/2009/091/000182Pfizer Limited183
Active, not recruiting
Phase 1
A Phase 3 Study of Fostamatinib Disodium in the Treatment Immune Thrombocytopenic PurpuraEUCTR2013-005453-76-CZRigel Pharmaceuticals, Inc.75
Active, not recruiting
Phase 1
This is a Phase 3 multi-center, randomized, double-blind, placebo-controlled, parallel group study to investigate the efficacy of 24 weeks of treatment with fostamatinib (R935788) vs. placebo in achieving a durable hemoglobin response in subjects with wAIHA who have failed at least one prior treatment regimen.EUCTR2018-004774-97-ATRigel Pharmaceuticals, Inc.90
Active, not recruiting
Phase 1
A Phase 3 Study of Fostamatinib Disodium in the Treatment Immune Thrombocytopenic PurpuraEUCTR2013-005453-76-ATRigel Pharmaceuticals, Inc.75
Active, not recruiting
Phase 1
Safety and Efficacy of Apremilast in Children 6 through 17 Years with Moderate to Severe Plaque PsoriasisPlaque PsoriasisEUCTR2018-002918-12-HUAmgen Inc.230