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 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT03710356
Eligibility Criteria:
Inclusion Criteria:
* with telomeropathy defined by the existence of a deleterious constitutional mutation of a gene involved in telomere maintenance (TERT, TERC, DKC1, TINF2, RTEL1, PARN, ACD, NHP2, NOP10, NAF1, WRAP53, CTC1, ERCC6L2, USB1, POT1, DNAJC21 or a newly identified gene responsible for telomeropathy ),
* 15 years or older,
* with severe haematological involvement (platelets \< 20 G/L or ANC \< 0.5 G/L and/or hemoglobin \< 8 g/dL and/or transfusion needs) and/or pulmonary fibrosis with parenchymal involvement greater than 10% on the CT scan.
* being able to give informed consent for patients 18 years and older,
* being able to give consent and have the consent of the holder (s) of parental authority for children over 15 years,
* being a beneficiary of social security scheme.
Exclusion Criteria:
* with HIV infection or active hepatitis B or C infection,
* with severe hepatic disease: ASAT and/or ALAT \> 5N, or direct bilirubinemia \> 30 μmol/L, TP \<50% (except vitamin K deficiency),
* having an active or treated tumor pathology for less than 5 years with the exception of a basocellular carcinoma or a in situ carcinoma of the cervix,
* with a history of organ or hematopoietic stem cell transplantation or with an indication of hematopoietic stem cell or organ transplantation within 6 months of inclusion,
* with an absolute contraindication to treatment with danazol: active thrombosis or history of thromboembolic disease, porphyria, severe renal or cardiac insufficiency (NYHA stage III or IV), androgen-dependent tumor, uncharacterized mammary nodules, pathological genital hemorrhage of undetermined etiology,
* who have already received danazol for the treatment of telomeropathy,
* having received another androgen within a period of less than 6 months,
* receiving another experimental treatment,
* receiving another hormonal therapy,
* receiving simvastatin,
* having a pregnancy plan and not committing to effective contraception while taking the treatment,
* breastfeeding,
* under guardianship or curators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT03710356
Study Brief:
Protocol Section:
NCT03710356