A Phase 3 interventional study of MNK-6105 and Placebo in Hepatic Encephalopathy, sponsored by Mallinckrodt. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-09-22.
Sponsored by Mallinckrodt · Phase 3, Interventional, and Treatment
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.
225 studies on the registry are indexed under Hepatic Encephalopathy; 53 are open to participants now.
Browse Hepatic Encephalopathy studies →Mallinckrodt is the lead sponsor of 87 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
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To be included, a patient must:
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:
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 · Drug: Standard of Care
Participants will receive SoC, along with continuous IV infusion of matching placebo for 5 days.
Drug: Placebo · Drug: Standard of Care
L-Ornithine Phenylacetate for IV infusion
Also known as: L-Ornithine Phenylacetate
Matching placebo for IV infusion
Also known as: Matching Placebo
Lactulose ± rifaximin as SoC treatment for overt HE should be administered per the clinical judgement of the investigator and usual institutional practice.
Also known as: SoC
Number of patients with a clinical response at Day 5
Time frame: at Day 5 (within 36 months)
Number of patients discharged 30 days after end of treatment.
Time frame: at Day 35 (within 36 months)
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)
Number of patients with adverse events or deaths during the study
Time frame: within 36 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is withdrawn, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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