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 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT01863004
Eligibility Criteria:
Inclusion Criteria:
* must carry at least one allele of a salvageable mis-sense mutation of dysferlin
* Age ≥ 18 years
* Written informed consent
Exclusion Criteria:
* Bleeding disorder
* Acute or chronic kidney failure (CCL \<50 ml/min)
* Advanced liver disease or active hepatitis
* Congestive heart failure NYHA III and IV
* Pregnancy or nursing
* Immunosuppression (prednisolone doses below 20 mg/d are allowed)
* Therapy with strong inhibitors of cytochrome P450 3A4
* HCV or HIV infection
* Regular alcohol consumption (\>14 drinks a week)
* Drug addiction
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01863004
Study Brief:
Protocol Section:
NCT01863004