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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.

Keyhole Limpet Hemocyanin in Chronic Hepatitis C and Compensated Cirrhosis - IM1 - KLH in CHC – IM1

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-004394-90-AT
Enrollment
Unknown
Registered
2011-12-12
Start date
2012-01-05
Completion date
Unknown
Last updated
2012-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with CHC and liver cirrhosis who are not applicable to standard therapy due to the presence of a contraindication. MedDRA version: 14.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0 Level: PT Classification code 10019759 Term: Hepatitis chronic persistent System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

Trade Name: Immucothel 1 mg - Trockensubstanz mit Lösungsmittel Product Name: Immucothel 1 mg Pharmaceutical Form: Concentrate and solvent for injection INN or Proposed INN: Immunocyanin Other descri

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Secondary end point(s): HCV RNA at week 1 HCV RNA at week 2 HCV RNA at week 4 HCV RNA at week 8 HCV RNA at week 12 HCV RNA at week 18 HCV RNA at week 32 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—

Countries

Austria

Contacts

Public ContactDepartment of Internal Medicine

Medical University of Graz

gastroenterologie@klinikum-graz.at0043316385 16122

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026