Ignite Creation Date:
2024-05-05 @ 9:57 PM
Last Modification Date:
2024-10-26 @ 10:11 AM
Study NCT ID:
NCT00999167
Status:
COMPLETED
Last Update Posted:
2024-07-10
First Post:
2009-10-08
Brief Title:
A Study of Safety and Efficacy of HPN-100 in Subjects With Cirrhosis and Episodic Hepatic Encephalopathy
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HALT-HE
Brief 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
Detailed Description:
Part A Open-label dose-escalation lead-in to assess HPN-100 safety and PK Approximately 10 subjects with HE and cirrhosis classified as Child Pugh B or C will undergo a one-step dose escalation over 4 weeks Subjects will initially receive 6 mL HPN-100 BID for 1 week On Day 7 and following satisfactory safety assessment of the subject the dose will be escalated to 9 mL BID for an additional 3 weeks
In addition to a safety assessment subjects will undergo 12-hour PK assessments on Days 7 and 28 with sampling at the following time points relative to the first dose 0 pre-first daily dose of HPN-100 2 4 8 approximately 2 hours before the second daily dose of HPN 100 and 12 hours post-first dose approximately 2 hours after the second daily dose of HPN-100 Additional PK samples will be collected on Days 8 15 and 21 at pre-first dose and 4 hours post-first dose
The DSMB will review all safety information including laboratory values to determine if Part B may be initiated
Subjects enrolled in Part A may be eligible for Part B as long as they meet the eligibility criteria
Part B Randomized double-blind assessment of HPN-100 in HE subjects Subjects who meet all entry criteria and are judged to be compliant with their prescribed SOC will be eligible for randomization to receive either HPN-100 or matching placebo for 16 weeks Efficacy will be assessed by the proportion of subjects experiencing episodes of HE as well as by other outcome measures including daily home assessments
Study acquired from Horizon in 2024
In addition to a safety assessment subjects will undergo 12-hour PK assessments on Days 7 and 28 with sampling at the following time points relative to the first dose 0 pre-first daily dose of HPN-100 2 4 8 approximately 2 hours before the second daily dose of HPN 100 and 12 hours post-first dose approximately 2 hours after the second daily dose of HPN-100 Additional PK samples will be collected on Days 8 15 and 21 at pre-first dose and 4 hours post-first dose
The DSMB will review all safety information including laboratory values to determine if Part B may be initiated
Subjects enrolled in Part A may be eligible for Part B as long as they meet the eligibility criteria
Part B Randomized double-blind assessment of HPN-100 in HE subjects Subjects who meet all entry criteria and are judged to be compliant with their prescribed SOC will be eligible for randomization to receive either HPN-100 or matching placebo for 16 weeks Efficacy will be assessed by the proportion of subjects experiencing episodes of HE as well as by other outcome measures including daily home assessments
Study acquired from Horizon in 2024
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None