Autoimmune Hemolytic Anemia Clinical Trial
Official title:
Clinical Characteristics and Treatment Outcomes of Patients With Autoimmune Hemolytic Anemia in Assiut University Hospital
Verified date | April 2021 |
Source | Assiut University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Autoimmune hemolytic anemia is characterized by shortened red blood cell survival and a positive Coombs test. The responsible autoantibodies may be either warm reactive or cold reactive. The rate of hemolysis and the severity of the anemia may vary from mild to severe and life-threatening. Diagnosis is made in the laboratory by the findings of anemia, reticulocytosis, a positive Coombs test, and specific serologic tests. The prognosis is generally good but renal failure and death sometimes occur, especially in cases mediated by drugs.
Status | Completed |
Enrollment | 150 |
Est. completion date | January 24, 2021 |
Est. primary completion date | January 24, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: patients diagnosed warm auto Immune hemolytic anemia primary or secondary(CLL, Lymphoma, rheumatoid arthritis , SLE,Drug-induced ) Exclusion Criteria: 1. All types of congenital hemolytic anemia 2. Microangiopathic hemolytic anemia ( Thrombotic thrombocytopenic purpura (TTP) , Hemolytic-uremic syndrome (HUS) , Disseminated intravascular coagulation (DIC) ) 3. Alloimmune hemolytic anemia 4. pregnancy |
Country | Name | City | State |
---|---|---|---|
Egypt | Assiut University Hospital | Assiut |
Lead Sponsor | Collaborator |
---|---|
Assiut University |
Egypt,
Dhingra KK, Jain D, Mandal S, Khurana N, Singh T, Gupta N. Evans syndrome: a study of six cases with review of literature. Hematology. 2008 Dec;13(6):356-60. doi: 10.1179/102453308X343518. Review. — View Citation
Garratty G. Immune hemolytic anemia associated with negative routine serology. Semin Hematol. 2005 Jul;42(3):156-64. Review. — View Citation
Kamesaki T, Oyamada T, Omine M, Ozawa K, Kajii E. Cut-off value of red-blood-cell-bound IgG for the diagnosis of Coombs-negative autoimmune hemolytic anemia. Am J Hematol. 2009 Feb;84(2):98-101. doi: 10.1002/ajh.21336. — View Citation
Michel M. [Characteristics of warm autoimmune hemolytic anemia and Evans syndrome in adults]. Presse Med. 2008 Sep;37(9):1309-18. doi: 10.1016/j.lpm.2008.01.026. Epub 2008 Jul 17. Review. French. — View Citation
Packman CH. The Clinical Pictures of Autoimmune Hemolytic Anemia. Transfus Med Hemother. 2015 Sep;42(5):317-24. doi: 10.1159/000440656. Epub 2015 Sep 11. Review. — View Citation
Salama A. Treatment Options for Primary Autoimmune Hemolytic Anemia: A Short Comprehensive Review. Transfus Med Hemother. 2015 Sep;42(5):294-301. doi: 10.1159/000438731. Epub 2015 Aug 10. Review. — View Citation
Zanella A, Barcellini W. Treatment of autoimmune hemolytic anemias. Haematologica. 2014 Oct;99(10):1547-54. doi: 10.3324/haematol.2014.114561. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in hemoglobin | Efficacy endpoint assesment | three week from baseline | |
Primary | frequency of drug-related side effects | safety endpoint | three week from base line | |
Secondary | Dose of steroid treatment | at 3 weeks, three months, six month, one year from baseline |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05057481 -
Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus
|
Phase 3 | |
Recruiting |
NCT05937828 -
OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
|
||
Recruiting |
NCT05263817 -
A Clinical Study of CD19/BCMA CAR-T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis
|
Early Phase 1 | |
Recruiting |
NCT05694312 -
Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL
|
Phase 2 | |
Completed |
NCT03538041 -
A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
|
Phase 2 | |
Recruiting |
NCT03918265 -
Tacrolimus Treatment for Refractory Autoimmune Cytopenia
|
Phase 4 | |
Completed |
NCT02389231 -
Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03576742 -
Severe Immune Cytopenia Registry Www.Sic-reg.Org
|
||
Active, not recruiting |
NCT04657094 -
Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia
|
Phase 2 | |
Recruiting |
NCT02828670 -
Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)
|
||
Recruiting |
NCT02877706 -
French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia
|
||
Recruiting |
NCT05931718 -
Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia
|
||
Completed |
NCT02158195 -
Immunopathology of Autoimmune Hemolytic Anemia
|
||
Completed |
NCT00001630 -
Treatment of Autoimmune Thrombocytopenia (AITP)
|
Phase 1 | |
Withdrawn |
NCT04039477 -
A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP
|
Phase 2 | |
Recruiting |
NCT04024202 -
Data Registry of Auto Immune Hemolytic Anemia
|
||
Not yet recruiting |
NCT05711264 -
Presence of Circulating Cluster of Differentiation 4 Positive 28 Null T Helper Lymphocytes(CD4+CD28-) in Patients With Autoimmune Hemolytic Anemia.
|
||
Completed |
NCT02689986 -
Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease
|
Phase 2 | |
Recruiting |
NCT06212154 -
CAR-T for Autoimmune Hemolytic Anemia Patients Who Have Failed Three or More Lines of Therapy
|
Phase 1 | |
Completed |
NCT04057703 -
Balance Benefit / Risk of Immunomodulatory Treatments at the Child and Adolescent for Autoimmune Cytopenia.
|