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G-CSF and Erythropoetin in Survival of Patients With Decompensated Liver Disease

This study is currently recruiting participants.
Verified July 2012 by Institute of Liver and Biliary Sciences, India
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01384565
First received: June 28, 2011
Last updated: February 19, 2013
Last verified: July 2012
History of Changes
  Purpose

Study Design

50 patients will be enrolled and randomized into patients (Group IA) and controls (Group I B)

Investigations:

Hematology CBC, Prothrombin time and INR Peripheral smear, Retics Biochemistry Liver function testing, AFP Kidney function testing Etiology of chronic liver disease Infectious etiology: total antiHBc, anti HCV, HCV RNA, HBV DNA Non infectious etiology: Autoimmune markers, copper studies, iron studies, HOMA IR, FBS Etiology of decompensation Variceal bleed Infection ( blood culture, urine culture, sputum culture, chest xray) Surgery Drugs Alcohol intake Ascitic fluid analysis UGI endoscopy Imaging USG abdomen with Doppler for spleno-portal axis CECT- Triple phase upper abdomen Liver regenerative potential efficacy testing Histology ( by transjugular liver biopsy) Liver Dendritic cells ( CD11c, CD40, CD 54, CD 123, BDCA 2 staining) by flow cytometry CD 34+ cells, CD 45+ cells and CD 133+ cells measurement in hepatic venous blood, peripheral blood and liver biopsy by flow cytometry Markers of proliferation like Ki- 67, proliferating cell nuclear antigen (PCNA) in liver biopsy Markers of angiogenesis like VEGF, v WF in hepatic venous blood Measurement of Hepatic venous pressure gradient ( HVPG)


Condition Intervention Phase
Chronic Liver Disease
 Drug: G-CSF+EPO
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Double Blind Trial to Study the Efficacy of G-CSF and Erythropoetin in Survival of Patients With Decompensated Liver Disease

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • transplant free survival at 1 year [ Time Frame: 3 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • transplant free survival at 6 months, histo-pathological evidence of hepatic regeneration and mobilization of CD34/stem cells, improvement in severity assessment indices [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: G-CSF+EPO Drug: G-CSF+EPO

Drug: Granulocyte Colony-stimulating Factor (G-CSF) and Erythropoetin (EPO)

G-CSF (in prefilled syringe) at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with Darbopoetin alpha 100 mcg/ week (in prefilled syringe) for 4 weeks (total 4 doses).

Arms: G-CSF+EPO Drug: Placebo

Placebo 1 (in prefilled syringe) s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with Placebo 2 every week (in prefilled syringe) for 4 weeks (total 4 doses).
Placebo Comparator: Placebo Drug: Placebo
Placebo 1 (in prefilled syringe) s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with Placebo 2 every week (in prefilled syringe) for 4 weeks (total 4 doses).

  Eligibility

Ages Eligible for Study:   12 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients who were known to have cirrhosis of liver with portal hypertension, now decompensated with ascites/ jaundice/ bleed/ HE/ HRS

Exclusion Criteria:

  • Age <12 or > 75 years

    • Autoimmune disorders
    • HCC
    • Sepsis ( Any culture positive: blood, urine, any other obvious source of infection: UTI, SBP)
    • Multi organ failure
    • Grade 4 HE
    • HIV seropositivity / pregnancy
    • Essential Hypertension
    • Patients being taken up for transplant
    • Refusal to participate in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384565

Contacts
Contact: Ankit Bhardwaj 011-46300000 bhardwaj.ankit3@gmail.com

Locations
India
Institute of liver and Biliary Sciences Recruiting
New Delhi, Delhi, India, 110070
Contact: Chandan Kumar, MD     011-46300000     <drchandankn@gmail.com>,    
Principal Investigator: Chandan Kumar, MD            
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Study Director: Shiv Kumar Sarin, MD,DM Institute of Liver & Biliary Sciences (ILBS)
  More Information

No publications provided

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01384565     History of Changes
Other Study ID Numbers: ILBS DLD 01
Study First Received: June 28, 2011
Last Updated: February 19, 2013
Health Authority: India: Ministry of Health

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Epoetin Alfa
Hematinics
 Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013