NCT03987893

Brief Summary

it is a single blind randomised control study which aims to study the effect of PEG3350 in resolution of overt hepatic encephalopathy in patients of acute on chronic liver failure. this will be compared with the standard of care in the management of hepatic encephalopathy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2018

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2018

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 17, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2020

Completed
Last Updated

June 17, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

June 13, 2019

Last Update Submit

June 14, 2019

Conditions

Hepatic EncephalopathyAcute-On-Chronic Liver Failure

Keywords

PEG3350hepatic encephalopathyacute on chronic liver failurelactuloserifaximinHESA

Outcome Measures

Primary Outcomes (2)

  • Improvement in survival.

    to look for any survival benefit in experimental arm at 28 days and 90 days

    At day 28 and day 90.

  • Improvement of encephalopathy by one or more grades.

    to look for the degree of improvement in grade of HE in both experimental arm and lactulose arm.

    24 hours, 48 hours and 72 hours

Secondary Outcomes (4)

  • Reduction in ammonia levels during and at the end of 48 hours, 72 hours and lactulose administration

    24 hours, 48 hours and 72 hours

  • Prolongation of time to death among non-survivors.

    30 days

  • Prevention / reduction of cerebral edema

    72 hours

  • Reduction of seizures frequency

    30 days

Study Arms (2)

PEG+Lactulose

EXPERIMENTAL

this arm will recieve PEG3350 in addition to standard of care

Drug: PEG-3350 with ElectolytesDrug: Lactulose

Lactulose alone

ACTIVE COMPARATOR

this arm will recieve only standard of care for management of hepatic encephlaopathy with ACLF

Drug: Lactulose

Interventions

PEG-3350 with ElectolytesDRUG

experimental arm will receive 2 doses of PEG3350 spaced over 12 hours after randomization to arm1. PEG as dose of 2litres (1 sachet dissolved in 2L of water) will be administered via a nasogastric tube.

PEG+Lactulose
LactuloseDRUG

Lactulose will be given orally (30ml QID) which shall be titrated to ensure 2-3 soft stools per day

Also known as: Lactulose per orally
Lactulose alonePEG+Lactulose

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-75 years.
  • Patients with ACLF with presence of hepatic encephalopathy \> grade 2 as per WHC

You may not qualify if:

  • Pregnant women or those who are suspected to be having acute fatty liver of pregnancy
  • Malarial hepatopathy, enteric hepatitis, or ischemic hepatitis.
  • Serum Na \<125 mEq/litre
  • Gastrointestinal (GI) obstruction, ileus, or gastric retention
  • Bowel perforation
  • Toxic colitis or toxic megacolon
  • Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam)
  • Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy
  • Uncontrolled infection with hemodynamic instability requiring vasopressors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Postgraduate Institute of Medical Education and Research

Chandigarh, 160012, India

RECRUITING

Related Publications (1)

  • Ahmed S, Premkumar M, Dhiman RK, Kulkarni AV, Imran R, Duseja A, Kaur P, Taneja S, Singh V, Mishra S, Roy A, Mehtani R. Combined PEG3350 Plus Lactulose Results in Early Resolution of Hepatic Encephalopathy and Improved 28-Day Survival in Acute-on-Chronic Liver Failure. J Clin Gastroenterol. 2022 Jan 1;56(1):e11-e19. doi: 10.1097/MCG.0000000000001450.

    PMID: 33060437DERIVED

MeSH Terms

Conditions

Hepatic EncephalopathyAcute-On-Chronic Liver Failure

Interventions

polyethylene glycol 3350Lactulose

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesLiver Failure, Acute

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Madhumita Premkumar, DM

    Post Graduate Institute of Medical Education and Research, Chandigarh

    STUDY CHAIR

Central Study Contacts

Syed Ahmed, MD

CONTACT

9035821510syedusman92@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
participant is randomised using a table of random numbers.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Open Label, randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 17, 2019

Study Start

May 20, 2018

Primary Completion

May 25, 2020

Study Completion

August 20, 2020

Last Updated

June 17, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)