Tacrolimus Treatment for Refractory Autoimmune Cytopenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03918265|
Recruitment Status : Not yet recruiting
First Posted : April 17, 2019
Last Update Posted : April 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autoimmune Hemolytic Anemia Pure Red Cell Aplasia Evans Syndrome||Drug: Tacrolimus||Phase 4|
Tacrolimus binds FKBP12 with high affinity after entry into cytoplasm, suppresses calcineurin activity and prevents nuclear translocation of transcription factors such as NF-AT that are involved in IL-2 gene transcription. As a result, T-cell activation is inhibited with a subsequent reduction in the production of cytokines that include IL-2, TNF-α, IL-3, IL-4, IFN-γ, IL-6 and IL-10; B-cell activation, class-switching and immunoglobulin production are also attenuated. Reports on the use of tarcrolimus in the treatment of autoimmune cytopenia are anecdotal and describe therapy with a variety of drug dosages.
The purpose of this study is to evaluate the effect of tacrolimus on patients with refractory autoimmune cytopenia, the side-effects will be documented and plasma concentration of tacrolimus will be monitor.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Tacrolimus Treatment for Refractory Autoimmune Cytopenia|
|Estimated Study Start Date :||April 10, 2019|
|Estimated Primary Completion Date :||October 10, 2019|
|Estimated Study Completion Date :||April 10, 2021|
Experimental: Efficiency of tacrolimus on autoimmune cytopenia
A prospective research of the tacrolimus efficiency on refractory autoimmune cytopenia patients. Dosage: 1mg bid and tacrolimus trough targets were 5-10 ng/ml throughout the study.
Medication time should last at least 6 months.
On refractory autoimmune cytopenia patients, tacrolimus was tried. Dosage: 1mg bid and tacrolimus trough targets were 5-10 ng/ml throughout the study
Other Name: tacrolimus capsule
- Hemoglobin level [ Time Frame: 6 months ]Hemoglobin level in g/L
- Platelet count [ Time Frame: 6 months ]Platelet count in /L
- Hemoglobin level [ Time Frame: 2 years ]Hemoglobin level in g/L
- Platelet count [ Time Frame: 2 years ]Platelet count in /L
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03918265
|Contact: Ruoxi Zhang, M.D.||+86 email@example.com|
|Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100730|
|Contact: Ruoxi Zhang, MD +86 18510064839 firstname.lastname@example.org|
|Principal Investigator:||Bing Hang, PhD||Peking Union Medical College Hospital|