A prospective trial to investigate the safety and efficacy of keyhole limpet hemocyanin (KLH) in patients with chronic hepatitis C infection and liver cirrhosis, who are unable to perform standard therapy due to contraindications.

Conditions: Patients with CHC and liver cirrhosis who are not applicable to standard therapy due to the presence of a contraindication.
MedDRA version: 14.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.0Level: PTClassification code 10019759Term: Hepatitis chronic persistentSystem Organ Class: 10019805 - Hepatobiliary disorders
Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Registration Number: EUCTR2011-004394-90-AT

Lead Sponsor: Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Gastroenterologie und Hepatologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- CHC of any Genotype
- compensated liver cirrhosis (Child Pugh A or Child Pugh B, 7 points)
- presence of at least one contraindication against standard therapy (Peginterferon alpha 2a/b and Ribavirin)

Contraindications are:
- hypersensitivity against Peginterferon alpha 2a/b and Ribavirin
- severe heart disease
- liver cirrhosis of Child Pugh =6
- hemoglobinopathias
- platelet count Thrombozytenzahl < 90000/mm 3
- neutrophil count absolute < 1500/mm 3
- psychosis, depression
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 15
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

1)hypersensitivity against KLH
2)immunosuppression (therapy with steroids, Azathioprin, Mycophenolat, TNF alpha blockers, calcineurin inhibitors, IL2 blockers)
3)hepatocellular carcinoma
4)coinfektion with hepatitis B and / or HIV
5)pregnancy
6)cardiovascular event (stroke, myocardial infarction) during the last 6 months
7)uncontrolled diabetes (HbA1c > 10)
8)chronic renal insufficiency (GFR < 50 ml/min) or chronic hemodialysis

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the safety and efficacy of keyhole limpet hemocyanin (KLH) to achieve sustained virological response in patients with chronic hepatitis C and compensated liver cirrhosis. ;Secondary Objective: To confirm the safety and efficacy of keyhole limpet hemocyanin to achieve biochemical response and decrease of viral load in patients with chronic hepatitis C and compensated liver cirrhosis. ;Primary end point(s): HCV RNA at week 24;Timepoint(s) of evaluation of this end point: Week 24

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): HCV RNA at week 1<br>HCV RNA at week 2<br>HCV RNA at week 4<br>HCV RNA at week 8<br>HCV RNA at week 12<br>HCV RNA at week 18<br>HCV RNA at week 32<br>ALT at weeks 1,2,4,8,12,18,32;Timepoint(s) of evaluation of this end point: Weeks 1,2,4,8,12,18,32