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A Study of the Safety and Efficacy of HPN-100 for Maintaining Remission in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy (HALT-HE)

Study:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of HPN-100 for Maintaining Remission in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy

Rationale:

n/a

Purpose:

This is a phase 2 study of HPN-100 in subjects with hepatic encephalopathy (HE) consisting of an open label safety lead-in (Part A), followed by randomized, double-blind, placebo-controlled treatment (Part B).

Study Status: Completed

Recruiting:
n/a

Condition Intervention Phase
Cirrhosis
Hepatic Encephalopathy		 Drug: HPN-100 (formerly known as GT4P)
Drug: Placebo		 Phase 2

Verified by Hyperion Therapeutics, Inc. January, 2012

Sponsored by: Hyperion Therapeutics, Inc.
Information provided by: Hyperion Therapeutics, Inc.
ClinicalTrials.gov identifier: NCT00999167

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Cleveland Clinic
Cleveland, Ohio 44195
United States

n/a

This information is abridged to display results relevant only to Cleveland Clinic. To see complete record visit ClinicalTrials.gov
  Information obtained from ClinicalTrials.gov on
Link to the current ClinicalTrials.gov record.