NCT01902511

Brief Summary

This will be a randomized double blind study which will be conducted on patients admitted to Department of Hepatology from June 2013 to may 2014 at ILBS, New Delhi. Patients not having any exclusion criteria will undergo bone marrow examination and liver biopsy at the baseline. 60 patients of decompensated cirrhosis will be randomised into two limbs- limb A (30 patients) will receive G-CSF and erythropoietin while those on limb B (30 patients) will receive G-CSF alone. The drugs will be given for 2 months and patient will be followed for 1 year. G-CSF will be given at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 60 (total 22 doses). Erythropoietin will be given s/c at dose of 500 IU/Kg twice a week for 2 months. Follow up will be done on days 0,3,7,14,28, day 42 (6 weeks), day 60 (2 months), day 90 (3 months), day 180 (6 months), day 270 (9 months); and day 360 (1 year).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2013

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 18, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

November 22, 2016

Status Verified

February 1, 2016

Enrollment Period

2.4 years

First QC Date

July 15, 2013

Last Update Submit

November 21, 2016

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

  • The primary end point will be transplant free survival rate at 1 year in patients with decompensated cirrhosis.

    1 Year

Secondary Outcomes (5)

  • Histopathological evidence of hepatic regeneration and mobilization of CD34/stem cells

    1 Year

  • Histopathological evidence of contribution of bone marrow precursor cells in hepatic regeneration and the markers predicting positive response to growth factors

    1 Year

  • Development of new complications such as appearance or worsening of hepatic encephalopathy, hepatorenal syndrome and sepsis.

    1 Year

  • Improvement in severity assessment scores and safety profile of G-CSF (Growth-Colony Stimulating Factor) + EPO (Erythropoetin)dual therapy vs. G-CSF alone.

    1 Year

  • Transplant free survival at 6 months in both groups

    6 months

Study Arms (2)

G-CSF + Erythropoietin

EXPERIMENTAL
Drug: G-CSF

G-CSF

ACTIVE COMPARATOR
Drug: G-CSF+Erythropoetin

Interventions

G-CSF+ErythropoetinDRUG
G-CSF
G-CSFDRUG
G-CSF + Erythropoietin

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 are known to have cirrhosis of liver with portal hypertension and are compensated on presentation with no features of ascites/ jaundice/ bleed/ HE/ HRS.
  • Only patients with alcoholic cirrhosis and cryptogenic cirrhosis (etiology work up negative) will be enrolled in the study.

You may not qualify if:

  • Sepsis ( Any culture positive: blood, urine, any other obvious source of infection: UTI, LRTI)
  • Variceal bleed in the past 3 months
  • Autoimmune disorders
  • HCC (Hepatocellular Carcinoma)
  • Multi organ failure
  • Any features of decompensation in form of ascites/Jaundice/ HE (grade 3 or 4) / HRS
  • HIV seropositivity
  • Essential hypertension
  • Pregnancy
  • Refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

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

Location

Related Publications (2)

  • Kumar D, Maheshwari D, Nautiyal N, Shubham S, Rooge S, Anand L, Vyas A, Kumari R, Sharma S, Bihari C, Mohanty S, Maiwall R, Kumar A, Sarin SK. Defects in energy metabolism are associated with functional exhaustion of bone marrow mesenchymal stem cells in cirrhosis. Am J Stem Cells. 2022 Feb 15;11(1):12-27. eCollection 2022.

    PMID: 35295591DERIVED

  • Anand L, Bihari C, Kedarisetty CK, Rooge SB, Kumar D, Shubham S, Kumar G, Sahney A, Sharma MK, Maiwall R, Kumar A, Sarin SK. Early cirrhosis and a preserved bone marrow niche favour regenerative response to growth factors in decompensated cirrhosis. Liver Int. 2019 Jan;39(1):115-126. doi: 10.1111/liv.13923. Epub 2018 Aug 10.

    PMID: 29962032DERIVED

MeSH Terms

Interventions

Granulocyte Colony-Stimulating Factor

Intervention Hierarchy (Ancestors)

Colony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Dr Lovkesh Anand, MD

    Institute of Liver & Biliary Sciences.

    PRINCIPAL INVESTIGATOR

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

July 15, 2013

First Posted

July 18, 2013

Study Start

July 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

November 22, 2016

Record last verified: 2016-02

Locations

IN(1)