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Clinical Trial Summary

To obtain short-term and long-term clinical safety information, in pediatric and adult patients with PA and MMA treated with Carbaglu®.

Clinical Trial Description

This study is being conducted to obtain short-term and long-term clinical safety information from adult and pediatric patients treated for hyperammonemia due to Methylmalonic Acidemia (MMA) and Propionic Acidemia (PA). This study will collect data on; developmental outcomes, details of treatment with Carbaglu® and other treatments for hyperammonemia including dietary and protein management, plasma ammonia levels, pregnancy and maternal complications, adverse effects on the developing fetus and neonate, adverse effects on the infant through first year of life. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05040178
Study type Observational
Source Recordati Rare Diseases
Contact Kathy Allen
Phone 908-849-4907
Email [email protected]
Status Not yet recruiting
Start date March 2022
Completion date March 2033

See also
  Status Clinical Trial Phase
Recruiting NCT03947034 - Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
Withdrawn NCT00279851 - Blood Sugars in Children With Idiopathic Seizures.