Liver Cirrhosis MedDRA version: 14.1 Level: PT Classification code 10001806 Term: Alpha-1 anti-trypsin deficiency System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1 Level: LLT Classification code 10009211 Term: Cirrhosis liver System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Trade Name: Granocyte 34 millionIU/ml
Product Name: Lenograstim (Granocyte)
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Pr
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18-70 inclusive Model of End stage Liver Disease (MELD) Score between 11.50 = MELD =65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Decompensated Liver Disease - uncontrolled ascites, recent (last 6 months) encephalopathy, recent (last 6 months) portal hypertensive bleeding Listed for transplantation Previous Liver Transplant Hepatocellular Carcinoma / Dysplastic Hepatic Nodules
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary aim of the trial is to examine whether administering either G-CSF alone or G-CSF followed by repeated infusions of stem cells is better than standard supportive care in improving severity of liver disease over 3 months. ; Primary end point(s): The primary outcome measure will be change in MELD (Model for End stage Liver Disease) score (delta MELD) calculated using MELD at randomisation (Day 0) and Day 90 MELD. ; Secondary Objective: The secondary aims are to examine whether either G-CSF alone or G-CSF followed by repeated stem cell infusions is better than standard supportive care in: a) reducing the amount of scarring in the liver b) improving quality of life c) reducing the number of complications related to liver disease d) improving survival (without needing a transplant) | — |
Countries
United Kingdom
Outcome results
None listed