NCT02788240

Brief Summary

All consecutive ACLF (Acute on Chronic Liver failure) patients presenting to the institute of liver and biliary sciences, irrespective of the etiology , who have survived the acute phase (i.e. 90 days of onset of the acute on chronic liver failure) and who are willing to participate in the study would be enrolled. After performing baseline biochemical tests, patients will undergo transjugular liver biopsy (TJLB), HVPG (Hepatic Venous Pressure Gradient), Circulating CD34 cells, Bone marrow aspiration and biopsy (Histopathological and immunohistochemical examination will be done).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

March 22, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2017

Completed
Last Updated

February 6, 2018

Status Verified

February 1, 2018

Enrollment Period

1.2 years

First QC Date

March 22, 2016

Last Update Submit

February 5, 2018

Conditions

Acute on Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

  • Transplant free survival in both groups

    1 year

Secondary Outcomes (13)

  • Quantitative assessment of CD34 positive cells in serum in both groups.

    1 year

  • Quantitative assessment of CD34 positive cells in liver biopsy samples in both groups.

    1 year

  • Reduction in liver disease severity indices like CTP (Child-Turcotte-Pugh) by more than one point in both groups.

    1 year

  • Reduction in liver disease severity indices like MELD Na ((Model for End Stage liver disease) by more than 2 points in both groups.

    1 year

  • Development of new onset complications such as hepatic encephalopathy in both groups.

    1 year

  • +8 more secondary outcomes

Study Arms (2)

Peg GCSF with standard medical therapy

EXPERIMENTAL
Drug: Peg GCSFBiological: 20% AlbuminDietary Supplement: NutritionOther: Bowel washDrug: Terlipressin 1- 4mg,if indicatedDrug: Meropenem or Imepenem, if indicated

Placebo with standard medical therapy

ACTIVE COMPARATOR
Biological: 20% AlbuminDietary Supplement: NutritionOther: Bowel washDrug: Terlipressin 1- 4mg,if indicatedDrug: Meropenem or Imepenem, if indicatedDrug: Placebo

Interventions

Peg GCSFDRUG
Peg GCSF with standard medical therapy
20% AlbuminBIOLOGICAL
Peg GCSF with standard medical therapyPlacebo with standard medical therapy
NutritionDIETARY_SUPPLEMENT
Peg GCSF with standard medical therapyPlacebo with standard medical therapy
Bowel washOTHER
Peg GCSF with standard medical therapyPlacebo with standard medical therapy
Terlipressin 1- 4mg,if indicatedDRUG
Peg GCSF with standard medical therapyPlacebo with standard medical therapy
Meropenem or Imepenem, if indicatedDRUG
Peg GCSF with standard medical therapyPlacebo with standard medical therapy
PlaceboDRUG
Placebo with standard medical therapy

Eligibility Criteria

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

You may qualify if:

  • Subjects aged 18-65 years
  • All patients who were known to have ACLF and have survived 3 months of the onset of acute event
  • Patients willing to participate in the study

You may not qualify if:

  • Presence of AKI (Acute Kidney Injury)
  • Active sepsis (Blood/ urine culture positive, SBP (Spontaneous bacterial Peritonitis, LRTI (lower Respiratory Tract infection)
  • Sickle cell anemia
  • HepatoCellular Carcinoma
  • Hematological malignancies
  • Multi organ failure
  • Grade 3/ 4 HE (Hepatic Encephalopathy)
  • HIV seropositivity
  • Pregnancy
  • Patients being taken up for transplant
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

AlbuminsNutritional StatusTerlipressinMeropenem

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ProteinsAmino Acids, Peptides, and ProteinsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaHealth StatusDemographyPopulation CharacteristicsLypressinVasopressinsPituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesOligopeptidesNerve Tissue ProteinsThienamycinsCarbapenemsbeta-LactamsLactamsAmidesOrganic ChemicalsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 22, 2016

First Posted

June 2, 2016

Study Start

May 1, 2016

Primary Completion

July 15, 2017

Study Completion

July 15, 2017

Last Updated

February 6, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)