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Switch-over and long-term extension study of HPN-100 vs sodium phenylbutyrate in Japanese patients with urea cycle disorder
jRCT2071220110Completed
- Sponsor
- Orphan Pacific
- Start
- Apr 2023
- Modality
- Small Molecules
- Countries
- 1
01
Overview
Open-label trial of glycerol phenylbutyrate in urea cycle disorder (UCD) (2 arms), sponsored by Orphan Pacific. Primary endpoint: Primary: 24-hour blood ammonia AUC on Day 7 (NaPBA) vs Day 14 (HPN-100). Started Apr 2023; status: completed.
02
Drugs
glycerol phenylbutyrate
03
Conditions
urea cycle disorder (UCD)
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