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 @ 11:56 PM
Ignite Modification Date:
2025-12-24 @ 11:56 PM
NCT ID:
NCT04269551
Eligibility Criteria:
Inclusion criteria :
* Male and/or female patients, ≥ 18 years of age with cold agglutinin disease as defined by:
1. Chronic hemolysis per Investigator's judgement,
2. Polyspecific direct antiglobulin test (DAT) positive,
3. Monospecific DAT strongly positive for C3d,
4. Cold agglutinin (CAg) titer ≥ 64 at 4 C; and,
5. IgG DAT ≤1+.
* A hemoglobin level ≤11 mg/dL.
* A total bilirubin level above the normal reference range that is thought to be due to hemolysis.
* Documented vaccinations against encapsulated bacterial pathogens (Neisseria meningitidis, including serogroup B meningococcus and Streptococcus pneumoniae) within five years of screening or willing to complete protocol specified vaccinations.
* Having given written informed consent prior to undertaking any study-related procedure.
Exclusion criteria:
* Cold agglutinin syndrome secondary to infection, rheumatologic disease, or known high grade hematologic malignancy, or known solid organ tumor.
* Clinically relevant infection of any kind within one month preceding screening.
* Treatment with anti-CD20 monotherapy within three months or anti CD20 combination therapies within six months prior to screening.
* Concurrent treatment with systemic immunosuppressive agents targeting B- or T-cell function and/or cytotoxic agents within 3 months prior to screening. Concurrent treatment with other systemic immunosuppressants within 5.5 half-lives of the drug prior to screening.
* Any specific complement system inhibitor within three months prior to screening.
* Concurrent treatment with systemic corticosteroids other than a stable daily dose equivalent to ≤10 mg/day prednisone within three months prior to screening.
* If female, pregnant or lactating.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04269551
Study Brief:
Protocol Section:
NCT04269551