Chronic Hepatitis C, Liver Cirrhosis
Conditions
Brief summary
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.
Interventions
Subcutaneous administration keyhole-limpet hemocyanin
Sponsors
Medical University of Graz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatitis C viral load at week 24 | 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Hepatitis c viral load at weeks 1,2,4,8,12,18,32 | 1,2,4,8,12,18,32 weeks |
Countries
Austria
Outcome results
None listed