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Trial record 1 of 1 for:    MNK61053106
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MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function

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ClinicalTrials.gov Identifier: NCT04128462
Recruitment Status : Not yet recruiting
First Posted : October 16, 2019
Last Update Posted : May 18, 2020
Sponsor:
Information provided by (Responsible Party):
Mallinckrodt

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.


Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Drug: MNK-6105 Drug: Placebo Drug: Standard of Care Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: MNK6105 + SoC

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
Drug: MNK-6105
L-Ornithine Phenylacetate for IV infusion
Other Name: L-Ornithine Phenylacetate

Drug: Standard of Care
Lactulose ± rifaximin as SoC treatment for overt HE should be administered per the clinical judgement of the investigator and usual institutional practice.
Other Name: SoC

Placebo Comparator: Placebo + SoC
Participants will receive SoC, along with continuous IV infusion of matching placebo for 5 days.
Drug: Placebo
Matching placebo for IV infusion
Other Name: Matching Placebo

Drug: Standard of Care
Lactulose ± rifaximin as SoC treatment for overt HE should be administered per the clinical judgement of the investigator and usual institutional practice.
Other Name: SoC




Primary Outcome Measures :
  1. Number of patients with a clinical response at Day 5 [ Time Frame: at Day 5 (within 36 months) ]

Secondary Outcome Measures :
  1. Number of patients discharged 30 days after end of treatment. [ Time Frame: at Day 35 (within 36 months) ]
  2. 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) ]
  3. Number of patients with adverse events or deaths during the study [ Time Frame: within 36 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04128462


Contacts
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Contact: For information about participating 800-556-3314 ext 5 clinicaltrials@mnk.com

Sponsors and Collaborators
Mallinckrodt
Investigators
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Study Director: Clinical Team Leader Mallinckrodt
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Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT04128462    
Other Study ID Numbers: MNK61053106
2019-001635-31 ( EudraCT Number )
First Posted: October 16, 2019    Key Record Dates
Last Update Posted: May 18, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mallinckrodt:
Overt HE diagnosis
Additional relevant MeSH terms:
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Hepatic Encephalopathy
Brain Diseases
Liver Diseases
Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases
Phenylacetic acid
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents