Efficacy and Safety of the Treatment of Pyruvate Dehydrogenase Deficiency Patients With Glycerol Phenylbutyrate (RAVICTI)
Recruiting
Phase 2
Interventional Study
Pyruvate Dehydrogenase Complex Deficiency Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 – 25
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 15 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
This is a phase II, multicenter, prospective, non-comparative clinical trial to assess the efficacy and safety of the treatment of pyruvate dehydrogenase deficiency (PDH) patients with glycerol phenylbutyrate (Ravicti®).
The trial will be conducted with three visits: 3 day hospitalizations including clinical consultations and paramedical procedures at Month 0 (M0), Month 3 (M3), Month 6 (M6).
Du…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* Child from 2 to 17 years of age Or
* Adult from 18 to 25 years of age
* With a PDH deficiency confirmed by molecular biology:
* a class 4 or 5- missense variant on the PDHA1 gene or
* one homozygous variant or two mixed heterozygous variants of class 4 or 5 that are misse…
Contacts