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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01181154 |
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Date of registration:
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12/08/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Rituximab in Auto-Immune Hemolytic Anemia
RAHIA |
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Scientific title:
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Rituximab in Adult's Warm Auto-Immune Hemolytic Anemia : a Phase III, Double-bind, Randomised Placebo-controlled Trial |
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Date of first enrolment:
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March 3, 2011 |
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Target sample size:
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32 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01181154 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Marc MICHEL, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assistance Publique - Hôpitaux de Paris |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Age > 18 years
2. AIHA defined at time of diagnosis by a Hgb level £ 10 g/dL, with a reticulocytes count
> 120 109/L, signs of hemolysis (at least a haptoglobin level < 4 mg/L), and a
positive direct antiglobulin test (DAT) ( IgG or IgG + complement pattern).
3. Disease duration equal or less than 6 weeks at time of inclusion --> removed by
amendment n°4 and substituted by :First episode of AIHA to "hot" antibody previously
untreated or treated corticosteroids for less than 6 weeks.
4. Patients with an associated autoimmune thrombocytopenia (Evans' syndrome) will be
eligible for the study if the platelet count is over 30 x 109/L at inclusion.
5. Normal level gammaglobulins in the serum (i.e. >5g/L) at inclusion.
6. Absence of detectable lymph nodes on a total body CT-scan (to be performed before
inclusion if not performed at diagnosis).
7. Effective means of contraception during treatment and for six months after completion
of treatment for all women of child bearing age
8. Negative serum pregnancy test within 14 days prior to study entry.
9. Written informed consent
Exclusion Criteria:
Previous treatment with rituximab
1. AIHA diagnosed and treated more than 6 weeks prior to inclusion removed by amendment
n°4 and substituted by AIHA relapsed or newly diagnosed but treated with
corticosteroids for more than 6 weeks
2. Ongoing immunosuppressive therapy (other than corticosteroids) or previous treatment
administered within 2 weeks prior to the beginning of the study treatment
3. Non-Hodgkin Lymphoma (NHL) other than stage A chronic lymphoid leukemia
4. Previous or concomitant malignancy other than basal cell or squamous cell carcinoma of
the skin, carcinoma-in-situ of the cervix, or other malignancy for which the patient
had not been disease-free for at least 5 years.
5. Autoimmune disorder such as SLE with at least one extra-hematological manifestation
requiring a treatment with steroids and/or immunosuppressive drugs.
6. Any other associated cause congenital or acquired hemolytic anemia (except thalassemia
trait or heterozygous sickle cell anemia).
7. Negative DAT or DAT positive with isolated anti-C3d pattern related to the presence of
a monoclonal IgM with cold agglutinin properties.
8. Positive HIV test and/or hepatitis virus C infection and/or positive hepatitis B virus
surface antigen (HbsAg).
9. Neutrophils count < 1,000/mm 3 at inclusion.
10. Impaired renal function as indicated by a serum creatinine level > 2 mg/d
11. Inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dL and/or
an AST or ALT level > 2x upper limit of normal.
12. New York Heart Classification III or IV heart disease.
13. Previous history of severe psychiatric disorder or are unable to comply with study and
follow-up procedures
14. Pregnant or lactating women, or woman planning to become pregnant within 12 months of
receiving study drug
15. Absence of written informed consent.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Warm Autoimmune Hemolytic Anemia
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Intervention(s)
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Drug: Placebo
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Drug: rituximab (Mabthera®)
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Primary Outcome(s)
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Overall response rate (complete and partial response) in both arms
[Time Frame: at 1 year]
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Secondary Outcome(s)
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Comparison in both arms of the number of transfusions of packed red blood cells in both arms
[Time Frame: at 1 year]
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Comparison of the incidence of serious side effects in both arms
[Time Frame: at 1 year]
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Comparison in both arms of the mean cumulative doses of prednisone
[Time Frame: at 1 year]
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Comparison in both arms of the number of days in hospital
[Time Frame: within the first year of follow-up]
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Comparison in both arm of the mortality
[Time Frame: at 1 year]
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Comparison in both arms of the number of patients requiring a splenectomy and/or an immunosuppressor
[Time Frame: during the first 12 months of follow-up]
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Comparison in both arm of overall response (CR + PR)
[Time Frame: at 2 years]
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Secondary ID(s)
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P080704
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2008-008255-42
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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