Clin2
NCT06255782Likely a fitRecruiting

Gene therapy study for baby boys with severe OTC deficiency

Ornithine Transcarbamylase DeficiencyOrnithine Transcarbamylase Deficiency DiseaseOrnithine Carbamoyltransferase Deficiency (Disorder)Urea Cycle Disorders, Inborn

Part of Brain & nervous system, Digestive system, Genetic & congenital, Hormones & metabolism clinical trials.

This trial tests a gene therapy called ECUR-506 for baby boys under 9 months old with a severe form of OTC deficiency. The goal is to see if it can help their bodies process ammonia better, reducing the need for a strict protein-restricted diet and medications.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
20 people
Ages
1 day to 7 months
Study type
Interventional

Who can take part

  • Your baby is a boy and at least 37 weeks when born
  • Age at screening is between 24 hours and 7 months old
  • Weighs at least 3.5 kg (about 7.7 lbs) and no more than 13.5 kg (about 29.8 lbs)
  • Has a confirmed genetic diagnosis of OTC deficiency with a severe form that caused a high ammonia crisis in the first week of life
  • Is currently on both a low-protein diet and ammonia-scavenging medications
  • Has received all age-appropriate vaccines

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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