Conditions: Hepatic Impairment
Keywords: Hepatic Impairment Liver Impairment Liver Disease Ferriprox® LI DFP Deferiprone
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 21
Healthy volunteers: yes

Brief summary:
Multi-center, non-randomized, open-label, single-dose, parallel group study to determine the effect of impaired hepatic function on the PK of deferiprone and its 3-O-glucuronide metabolite following a single oral dose of 33mg/kg Ferriprox®.

Detailed description:
Post-marketing study to evaluate the effect of impaired hepatic function on the pharmacokinetics (PK) of deferiprone and its 3-O-glucuronide metabolite and on the safety of Ferriprox® in subjects with mild and moderate hepatic impairment as compared to healthy volunteers.

Arms:
arm 1: Healthy volunteers with normal hepatic function received a single 33 mg/kg dose of Ferriprox®. arm 2: Subjects with mild hepatic failure as defined by the Child-Pugh Class C: 5-6 points received a single 33 mg/kg dose of Ferriprox®. arm 3: Subjects with moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points received a single 33 mg/kg dose of Ferriprox®.

Interventions: intervention 1: Ferriprox®
Intervention descriptions: intervention 1: None

Protocol document: