Keyhole Limpet Hemocyanin in Chronic Hepatitis C
Not Applicable
Completed
- Conditions
- Chronic Hepatitis CLiver Cirrhosis
- Interventions
- Drug: keyhole-limpet hemocyanin
- Registration Number
- NCT01509391
- Lead Sponsor
- Medical University of Graz
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 14
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Keyhole-limpet hemocyanine keyhole-limpet hemocyanin -
- Primary Outcome Measures
Name Time Method Hepatitis C viral load at week 24 24 weeks
- Secondary Outcome Measures
Name Time Method Hepatitis c viral load at weeks 1,2,4,8,12,18,32 1,2,4,8,12,18,32 weeks
Trial Locations
- Locations (1)
Medical University of Graz
🇦🇹Graz, Austria