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.
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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

Pascale De Lonlay, MD, PhD

01 44 49 58 52

pascale.delonlay@aphp.fr

CONTACT

Gael Plastow, Project advisor

01 44 38 18 57

gael.plastow@aphp.fr

CONTACT