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:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT01314560
Eligibility Criteria:
Inclusion Criteria:
* Patient with a clinical syndrome of Lowe (congenital cataracts, renal tubular dysfunction and neuromuscular damage) with a molecular defect in the gene known OCRL1.
* For the centre of Necker, patients should have a weight\> 10 kg. For the centre of Toulouse site, patients should have a weight\> 40 kg.
* No alteration of glomerular function (creatinine clearance\> 30 ml/min/1.73m ²)
* No significant anemia (hematocrit\> 25%, hemoglobin\> 8 g / L)
* Every patient should have included a signed informed consent. For minor patients, the consent of parents or legal guardian must be obtained.
* Patients may be included only if they receive social security coverage or CMU
Exclusion Criteria:
* Weight less than 10 kg for the centre of Necker
* Weight less than 40 kg for the centre of Toulouse
* Major renal insufficiency (creatinine clearance \<30 ml/min/1.73m ²)
* Profound anemia (hematocrit \<25%, Hb \<8g/dl)
* Patients taking drugs interfering with hemostasis in the eight days before the survey
* Patients with major behavior disorder making it difficult to achieve the blood sample, despite the nitrous oxide
* Patients with a other pathology of hemostasis (hemophilia, thrombotic disease)
* Participation in another clinical study requiring a blood sample within 4 weeks
* Contraindication to EMLA patch: confers Summary of Product Characteristics.
* Contraindication to KALINOX: confers Summary of Product Characteristics.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
6 Years
Maximum Age:
45 Years
Study:
NCT01314560
Study Brief:
Protocol Section:
NCT01314560