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MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function

Primary Purpose

Hepatic Encephalopathy

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MNK-6105
Placebo
Standard of Care
Sponsored by
Mallinckrodt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Overt HE diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

To be included, a patient must:

  • Be the age of majority in their country (considered an adult)
  • Be male or non-pregnant, non-lactating female
  • Have OHE (Stage 2, 3, or 4) as a complication of cirrhosis
  • Have been hospitalized within 24 hours before start of infusion (SOI)
  • Receive at least 6 hours of SoC treatment

Exclusion Criteria:

Patients will be excluded if they have inadequate renal function or any other disease, laboratory value, or condition (including allergy, drug use or treatments) that per protocol or in the opinion of the investigator, might increase the risk of compromising:

  1. health or well-being of the patient
  2. safety of study staff
  3. analysis of results

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    MNK6105 + SoC

    Placebo + SoC

    Arm Description

    Participants will receive standard of care (SoC), along with MNK-6105 delivered by continuous intravenous (IV) infusion as follows: Loading dose: 20 g infused over 6 hours Intermediate dose: 15 g infused over 18 hours Maintenance dose: 15 g infused over 24 hours for up to 4 days

    Participants will receive SoC, along with continuous IV infusion of matching placebo for 5 days.

    Outcomes

    Primary Outcome Measures

    Number of patients with a clinical response at Day 5

    Secondary Outcome Measures

    Number of patients discharged 30 days after end of treatment.
    Number of patients readmitted to the hospital due to overt hepatic encephalopathy (OHE) 30 days after discharge.
    Number of patients with adverse events or deaths during the study

    Full Information

    First Posted
    October 14, 2019
    Last Updated
    September 16, 2021
    Sponsor
    Mallinckrodt
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04128462
    Brief Title
    MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function
    Official Title
    A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of MNK6105 (an Intravenous Formulation of L-Ornithine Phenylacetate) in Hospitalized Patients With Cirrhosis and Hyperammonemia Associated With an Episode of Hepatic Encephalopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Business Decision
    Study Start Date
    November 2021 (Anticipated)
    Primary Completion Date
    April 2025 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mallinckrodt

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study is for patients with cirrhosis and hepatic encephalopathy who are in the hospital. This means they have a high ammonia level which is affecting their brain function. All patients will receive the standard of (regular) care. Each will have an equal chance (like flipping a coin) of receiving the experimental drug or placebo along with the standard care. Each patient will have tests during the first 24 hours, receive treatment for up to 5 days, and have 30 days of follow-up.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hepatic Encephalopathy
    Keywords
    Overt HE diagnosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MNK6105 + SoC
    Arm Type
    Experimental
    Arm Description
    Participants will receive standard of care (SoC), along with MNK-6105 delivered by continuous intravenous (IV) infusion as follows: Loading dose: 20 g infused over 6 hours Intermediate dose: 15 g infused over 18 hours Maintenance dose: 15 g infused over 24 hours for up to 4 days
    Arm Title
    Placebo + SoC
    Arm Type
    Placebo Comparator
    Arm Description
    Participants will receive SoC, along with continuous IV infusion of matching placebo for 5 days.
    Intervention Type
    Drug
    Intervention Name(s)
    MNK-6105
    Other Intervention Name(s)
    L-Ornithine Phenylacetate
    Intervention Description
    L-Ornithine Phenylacetate for IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Matching Placebo
    Intervention Description
    Matching placebo for IV infusion
    Intervention Type
    Drug
    Intervention Name(s)
    Standard of Care
    Other Intervention Name(s)
    SoC
    Intervention Description
    Lactulose ± rifaximin as SoC treatment for overt HE should be administered per the clinical judgement of the investigator and usual institutional practice.
    Primary Outcome Measure Information:
    Title
    Number of patients with a clinical response at Day 5
    Time Frame
    at Day 5 (within 36 months)
    Secondary Outcome Measure Information:
    Title
    Number of patients discharged 30 days after end of treatment.
    Time Frame
    at Day 35 (within 36 months)
    Title
    Number of patients readmitted to the hospital due to overt hepatic encephalopathy (OHE) 30 days after discharge.
    Time Frame
    30 days after discharge (within 36 months)
    Title
    Number of patients with adverse events or deaths during the study
    Time Frame
    within 36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: To be included, a patient must: Be the age of majority in their country (considered an adult) Be male or non-pregnant, non-lactating female Have OHE (Stage 2, 3, or 4) as a complication of cirrhosis Have been hospitalized within 24 hours before start of infusion (SOI) Receive at least 6 hours of SoC treatment Exclusion Criteria: Patients will be excluded if they have inadequate renal function or any other disease, laboratory value, or condition (including allergy, drug use or treatments) that per protocol or in the opinion of the investigator, might increase the risk of compromising: health or well-being of the patient safety of study staff analysis of results
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Clinical Team Leader
    Organizational Affiliation
    Mallinckrodt
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function

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