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Phase 2 N=15 Randomized Quadruple-blind Treatment

A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy

Cirrhosis · Hepatic Encephalopathy

Bottom Line

View on ClinicalTrials.gov: NCT00999167 ↗
Enrolled (actual)
15
Serious AEs
19.2%
Results posted
Sep 2015
Primary outcome: Primary: Part A: The Rate of AEs and Tolerability of HPN-100 — 11; 9; 7; 4 Subjects

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
HPN-100 (Drug); Placebo (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Amgen
Primary completion
Apr 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Part A: The Rate of AEs and Tolerability of HPN-100		 11; 9; 7; 4; 4; 2 —
PRIMARY
Part B: Proportion of Subjects Who Exhibit an HE Episode, Defined as Either of the Following During the Treatment Phase: WH ≥2; WH Grade and Asterixis Grade Increase of 1 Each, if Baseline WH = 0		 19; 32 0.0214 sig
SECONDARY
Total Number of HE Events		 35; 57 0.0354 sig
SECONDARY
Time to Meeting the Primary Endpoint		 NA; NA 0.047 sig
SECONDARY
Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Score		 -0.5; 3.2; -10.7; -9.7 0.0713

Summary

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).

Eligibility Criteria

Inclusion Criteria

  • Subjects aged 18 and over
  • Clinical diagnosis of cirrhosis of any cause
  • Potential to benefit from HE treatment
  • History of greater than or equal to 2 documented episodes of WH Grade 2 or more HE within the past 6 months, at least one of which occurred within the preceding 3 months
  • No change in other HE-specific medications within 1 week before randomization
  • Able to give informed consent and comply with study activities
  • Availability of at least one designated family member or caregiver who is capable of and willing to assume responsibility for facilitating subject compliance with study procedures
  • All females of childbearing age and all sexually active males must agree to use an acceptable method of contraception throughout the study.

Exclusion Criteria

  • Use of any investigational drug within 30 days
  • Use of prohibited medications
  • Uncontrolled infection
  • Active GI bleeding or a history of GI bleeding requiring blood transfusion (> 2 units) within 3 months
  • Transjugular intrahepatic portosystemic shunt (TIPS) placement or revision within the past 90 days
  • Recreational drug use or alcohol consumption for subjects with a history of alcohol or drug abuse within 6 months
  • Lactating and/or pregnant females
  • Active malignancy
  • Clinically significant bowel disease, including obstruction, inflammatory bowel disease, or malabsorption
  • Expected to undergo transplantation within 6 months
  • Model for end-stage liver disease (MELD) score of > 25
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00999167). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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