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A Non-Interventional Post-Authorization Safety Study (PASS) of Carbaglu® for the Treatment of Hyperammonemia Due to Methylmalonic Acidemia (MMA) and Propionic Acidemia (PA) in Adult and Pediatric Patient Populations

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A Non-Interventional Post-Authorization Safety Study (PASS) of Carbaglu® for the Treatment ofHyperammonemia Due to Methylmalonic Acidemia (MMA) and Propionic Acidemia (PA)in Adult and Pediatric Patient Populations

ClinicalTrials.gov ID NCT05040178

Sponsor Recordati Rare Diseases

Information provided by Recordati Rare Diseases (Responsible Party)

Last Update Posted 2024-01-30

Study Overview

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

Detailed 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 is an observational/non-interventional study. Patients will be treated per the prescribing information and routine medical practice.

Only available data will be collected as part of the study including 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.