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RECRUITING
NCT05040178

An Observational Study of Carbaglu® for the Treatment of MMA and PA in Adults and Pediatrics

Sponsor: RECORDATI GROUP

View on ClinicalTrials.gov

Summary

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

Official title: 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2022-06-30

Completion Date

2032-06-30

Last Updated

2025-04-15

Healthy Volunteers

No

Interventions

DRUG

Carglumic Acid

Current or previous treatment with Carbaglu, the dose of Carbaglu® prescribed will be determined by the investigator for each individual patient.

Locations (5)

Children's National Hospital

Washington D.C., District of Columbia, United States

University of South Florida

Tampa, Florida, United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States

Riley Children's Hospital

Indianapolis, Indiana, United States

Icahn School of Medicine at Mt. Sinai

New York, New York, United States