Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-24 @ 9:34 PM
NCT ID:
NCT01134432
Eligibility Criteria:
Inclusion Criteria:
* Age 18 years or over
* Clinical and biochemical signs of haemolytic anaemia
* Positive Coombs test with anti-IgG on its own or with anti-CD3d
* Adequate contraceptive measures (intrauterine device, contraceptive pill or gestagen deposit) for women of childbearing potential
Exclusion Criteria:
* Performance status \> 2
* Previous treatment with Rituximab
* Other immune suppressive or anti neoplastic treatment including prednisolone within 3 months
* Auto immune haemolytic anaemia within 6 months
* Other serious disease
* Pregnant women and nursing mothers. Adequate contraceptive measures must be taken for the duration of the study.
* Contraindication for treatment with Rituximab, i.e. patients that develop hypersensitivity/allergy to the contents of the drug or have antibodies against murine proteins.
* Active infection which requires antibiotic treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01134432
Study Brief:
Protocol Section:
NCT01134432