Liver cirrhosis MedDRA version: 14.1 Level: LLT Classification code 10024667 Term: Liver cirrhosis System Organ Class: 10019805 - Hepatobiliary disorders
Conditions
Interventions
Trade Name: INCRELEX
Pharmaceutical Form: Solution for injection
INN or Proposed INN: MECASERMIN
CAS Number: 68562-41-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Conc
Sponsors
Foundation for Liver Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 18-70 year old. Confirmed diagnosis of liver cirrhosis by laparoscopy, liver biopsy and/or clinical, biochemical and imaging studies. Child-Pugh score 6 or more. Plasma IGF-I level below the lower 2.5th percentile and adjusted for age (plasma IGF-I ? -2 SD Z-score). Willing and able to give a written informed consent to participate in the study, including all study procedures and follow-up visits. Alcohol abstinence for at least 3 months before entering the study. Eligible for liver transplantation, and being put on the liver transplant waiting list. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 6 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Tense ascites requiring repeated paracenteses (two or more in the preceding year). Severe peripheral edema. Hospitalization for gastrointestinal bleeding, spontaneous bacterial peritonitis or other life-threatening complications within 3 months before entering the study. Episode of encephalopathy requiring protein restriction, or hepatic encephalopathy that precludes participation. Drug abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the subsequent effects during 6 months of rhIGF-I treatment on body composition as measured by Dual-energy X-ray absorptiometry (DXA): muscle mass/non-fat-non-mineral mass, fat mass and bone mineral density.;Secondary Objective: To assess the effects of stated treatment on (a) the liver function (bilirubin, albumin, total protein, liver enzymes, PT, APTT, antithrombin III, cholinesterase), (b) the respiratory quotient, (c) the resting energy metabolism and (d) the quality of life (Sickness Impact Profile).;Primary end point(s): The main study endpoint is when 6 patients have been treated with rhIGF-I for 6 months. ;Timepoint(s) of evaluation of this end point: No timepoints. We evaluate whether a patient is the last patient treated. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): No secondary end point.;Timepoint(s) of evaluation of this end point: Not applicable. | — |
Countries
Netherlands
Contacts
Public ContactProject manager
Foundation for Liver Research
Outcome results
None listed