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

NCT01384565 | Completed Phase 3

• 1 other identifier: ILBS DLD 01
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Chronic Liver Disease

Outcome Measures

Primary Outcomes (1)

• transplant free survival at 1 year

  3 Months

Secondary Outcomes (1)

• transplant free survival at 6 months, histo-pathological evidence of hepatic regeneration and mobilization of CD34/stem cells, improvement in severity assessment indices

  6 Months

Study Arms (2)

G-CSF+EPO

ACTIVE COMPARATOR

Drug: G-CSF+EPO

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

G-CSF+EPO DRUG

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).

G-CSF+EPO

Placebo DRUG

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

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of liver and Biliary Sciences

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

Location

Related Publications (1)

• Kedarisetty CK, Anand L, Bhardwaj A, Bhadoria AS, Kumar G, Vyas AK, David P, Trehanpati N, Rastogi A, Bihari C, Maiwall R, Garg HK, Vashishtha C, Kumar M, Bhatia V, Sarin SK. Combination of granulocyte colony-stimulating factor and erythropoietin improves outcomes of patients with decompensated cirrhosis. Gastroenterology. 2015 Jun;148(7):1362-70.e7. doi: 10.1053/j.gastro.2015.02.054. Epub 2015 Mar 4.

  PMID: 25749502 DERIVED

Study Officials

• Shiv Kumar Sarin, MD,DM

  Institute of Liver & Biliary Sciences (ILBS)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2011
• First Posted: June 29, 2011
• Study Start: July 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: March 1, 2013
• Last Updated: July 31, 2013

Record last verified: 2012-07

Locations

IN (1)