|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT02389231 |
|
Date of registration:
|
13/02/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment
ANEMIL |
|
Scientific title:
|
" Anemil Trial ": Phase I/II Clinical Trial Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment |
|
Date of first enrolment:
|
May 17, 2017 |
|
Target sample size:
|
2 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02389231 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
|
|
Phase:
|
Phase 1/Phase 2
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Estibaliz LAZARO, Prof |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Hospital, Bordeaux |
|
|
Name:
|
Rodolphe THIEBAUT, Prof |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University Hospital, Bordeaux |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Adults (18 years old)
- wAHAI defined by the presence of hemolysis and positive coombs test (IgG +/-C3)
- Absence of infection or other hematologic disease
- wAHAI not responding to conventional steroids despite a dose over 10 mg
- No treatment with rituximab for a minimum of 6 months
- Signed informed consent form
Exclusion Criteria:
- Less than 18 years old
- Cold AHAI
- IL2 allergy
- Chemiotherapy or immunosuppressive treatment
- Treatment with rituximab for less than 6 months
- Neoplasia or hematologic malignancy
- Aplastic anemia
- Neutropenia = 1000 mm3
- Infection
- Hepatitis B or C
- wAHAI associated with systemic lupus erythematosus depending on ACR criteria
- Cardiac insufficiency
- Hypertension
- Pulmonary insufficiency
- Liver cirrhosis
- Thrombopenia below 50000/mm3
- Drug addiction, alcohol abuse
- Psychiatric disorder
- Absence of signed informed consent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Autoimmune Hemolytic Anemia
|
|
Intervention(s)
|
|
Drug: Interleukine-2
|
|
Primary Outcome(s)
|
|
Percentage of LTCD8+CD25highFoxp3+ .
[Time Frame: 9 weeks after inclusion]
|
|
Secondary Outcome(s)
|
|
Incidence of complications with the treatment.
[Time Frame: 6 months after inclusion]
|
|
Dose of steroid treatment
[Time Frame: 5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion]
|
|
Evaluation of lymphocyte activation.
[Time Frame: 5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion]
|
|
Hemolysis as measured by hemoglobin, haptoglobin, reticulocytes and LDH levels
[Time Frame: 5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion]
|
|
Evaluation of lymphocyte sub-populations
[Time Frame: 5 days, 20 days, 40 days, 61 days, 63 days and 6 months after inclusion]
|
|
Secondary ID(s)
|
|
CHUBX 2013/29
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|