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 @ 5:56 PM
Ignite Modification Date:
2025-12-24 @ 5:56 PM
NCT ID:
NCT02201368
Eligibility Criteria:
Inclusion Criteria:
All patients with any of the following conditions:
* Long-chain 3-hydroxyacyl-coenzyme A dehydrogenase deficiency (LCHAD).
* Very long-chain acyl-coenzyme A dehydrogenase deficiency (VLCAD.)
* Mitochondrial trifunctional protein (MTP).
* Carnitine palmitoyltransferase I deficiency (CPT I).
* Carnitine Palmitoyltransferase II (CPT II).
* Carnitine-acylcarnitine translocase deficiency (CACT).
Positive skin biopsy: patients were deemed to commence the dietary treatment with Triheptanoin after evaluating the individual response in vitro in cultured fibroblasts. This response is based on the measurement of the production of propionyl-CoA, the incubation with fatty acids odd-chain, compared with control group fibroblasts.
The informed consent must be signed by the patient or family, in the case of minors.
Exclusion Criteria:
* No patient/family collaboration or the application of dietary treatment.
* No in vitro test response.
* Do not meet the inclusion criteria.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02201368
Study Brief:
Protocol Section:
NCT02201368