Cirrhosis Clinical Trial
Official title:
Effects of the Administration of Ornithine Phenylacetate in Patients With Cirrhosis and Upper Gastrointestinal Bleeding
The main objective is to evaluate the effectiveness of the experimental drug to reduce
plasma ammonia concentration at a dose that is safe and well tolerated. Ammonia usually
rises significantly in the hours after gastrointestinal bleeding in patients with cirrhosis
of the liver. This increase in the concentration of ammonia facilitates the development of
hepatic encephalopathy.
The study will be divided in two parts:
Part A: Open-label, dose-escalating, single cohort study. The goal of this phase is to
confirm the tolerance and safety of the dose of OP that is being proposed for the study
according to the results of phase I and phase II studies in healthy subjects and stable
outpatients with cirrhosis.
Part B: Multi-center (2 University Hospitals), double-blind, randomized, parallel-group
trial. Assignment of treatment will be done according to a list (one at each study site) of
random numbers in blocks that will be concealed until the end of the study. The control
group will be assigned to placebo on a 1:1 ratio. The placebo and treatment will be masked.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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