Phase 2
Completed N=15
A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy
Cirrhosis · Hepatic Encephalopathy
Source: ClinicalTrials.gov NCT00999167 ↗
Enrolled (actual)
15
Serious AEs
19.2%
Results posted
Sep 2015
Primary outcomePrimary: Part A: The Rate of AEs and Tolerability of HPN-100 — 11; 9; 7; 4 Subjects
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).
Outcome Measures
| Outcome | Result | p-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 |
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
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. Informational only — not medical advice.