Keyhole Limpet Hemocyanin in Chronic Hepatitis C

Medical University of Graz14 enrolled

Overview

In this study the investigators examine the safety and efficacy of Keyhole-limpet-hemocyanin in patients with chronic hepatitis c infection and liver cirrhosis. The investigators hypothesize that administration of keyhole-limpet-hemocyanin reduces the viral load in patients infected with hepatitis c.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Hepatitis C Liver Cirrhosis

Interventions

keyhole-limpet hemocyaninDRUG

Subcutaneous administration keyhole-limpet hemocyanin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Chronic Hepatitis C infection * no previous therapy * at least one contraindication to interferon therapy * liver cirrhosis * age between 18-80 y * women of not childbearing age Exclusion Criteria: * Hypersensitivity against keyhole-limpet hemocyanin * previous treatment against hepatitis c * autoimmune disorders * immunosuppression * hepatocellular carcinoma or other malignancies * coinfection with hepatitis b or HIV * pregnancy * cardiovascular event during the last 6 months (stroke or MCI) * uncontrolled diabetes * renal insufficiency (GFR \< 50 ml/min) or chronic hemodialysis

Locations (1)

Medical University of Graz

Graz, Austria

Outcomes

Primary Outcomes

Hepatitis C viral load at week 24

Time frame: 24 weeks

Secondary Outcomes

Hepatitis c viral load at weeks 1,2,4,8,12,18,32

Time frame: 1,2,4,8,12,18,32 weeks

Data from ClinicalTrials.gov

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