Last reviewed · How we verify
NCT04096014
Late Evening and Early Morning Protein Supplement to Reduce Readmissions for Hepatic Encephalopathy
NA trial testing Ensure Enlive in Hepatic Encephalopathy in 40 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | The Cleveland Clinic |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 40 |
| Start date | 16 September 2019 |
| Primary completion | 30 June 2026 |
| Estimated completion | 30 October 2026 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Ensure Enlive
- Standard Of Care
Conditions studied
- Hepatic Encephalopathy — all drugs for Hepatic Encephalopathy →
Sponsor
The Cleveland Clinic
Who can join
Adults 18 to 75, any sex, with Hepatic Encephalopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Readmission rates for patients with hepatic encephalopathy due to end stage liver disease are high. Hyperammonemia contributes significantly to encephalopathy and occurs because of impaired hepatic ureagenesis and increased skeletal muscle proteolysis. We propose a randomized, 6-month nutritional intervention in cirrhotic patients who have had at least 1 admission for hepatic encephalopathy within the last 6 months. We hypothesize that a combination of late evening and early morning protein supplement (Ensure Enlive) will decrease recurrent hepatic encephalopathy and consequent readmission rates by lowering skeletal muscle proteolysis and improved lean body mass.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Future Therapies of Hepatic Encephalopathy.
Buckholz AP, Brown RS. · · 2024 · cited 5× · PMID 38548443 · DOI 10.1016/j.cld.2024.02.002
Verify or expand the search:
- PubMed search for NCT04096014
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ensure Enlive
Trials testing the same drug.
- NCT04522388 — Examining the Effect of Nutritional Supplementation on Skeletal Muscle Mass in Patients Awaiting Lung Transplant · NA · terminated
Other recruiting trials for Hepatic Encephalopathy
Currently open trials in the same condition.
- NCT07521332 — Apixaban-PK Trial: Preventing Portal Hypertension Complications in Cirrhosis · Phase 4 · recruiting
- NCT07418008 — The Liver Cirrhosis Cognitive Decline Scale (LiCCoS) · recruiting
- NCT06953921 — Correlation Between Serum Albumin Level and Severity of Hepatic Encephalopathy in Patients With Chronic Liver Disease in · recruiting
- NCT07437638 — Clinical Efficacy and Survival Prediction Analysis of Transjugular Intrahepatic Portosystemic Shunt in Patients With Liv · active not recruiting
- NCT06425380 — Pilot Open-Label Trial of Resistant Potato Starch in Patients With Cirrhosis and Overt Hepatic Encephalopathy · NA · recruiting
Other The Cleveland Clinic trials
Trials by the same sponsor.
- NCT07218198 — Clinical Decision Support Tool for the Treatment of Uncontrolled Hypertension · NA · not yet recruiting
- NCT07442747 — Neural Mechanisms of Aerobic Exercise Benefits in PD With DBS · NA · not yet recruiting
- NCT07471464 — Centered Surgery - Preoperative Counseling and Patient Satisfaction · recruiting
- NCT07073963 — Virtual Patient Groups for Sarcoidosis Associated Fatigue · NA · recruiting
- NCT07363343 — Nifedipine and Enalapril vs Nifedipine and Labetalol for the Treatment of Postpartum Hypertension Study · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04096014 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Cleveland Clinic
- Last refreshed: 25 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04096014.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing