THE EFFECTS OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-1 ON THE NUTRITIONAL STATUS IN PATIENTS WITH LIVER CIRRHOSIS: A PILOT-STUDY.

Conditions: iver cirrhosis
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
MedDRA version: 14.1Level: LLTClassification code 10024667Term: Liver cirrhosisSystem Organ Class: 10019805 - Hepatobiliary disorders

Registration Number: EUCTR2012-001239-30-NL

Lead Sponsor: Foundation for Liver Research

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures