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NCT01509391 Clinical Trial

Keyhole Limpet Hemocyanin in Chronic Hepatitis C

Liver Cirrhosis Clinical Trial

— IM1  

Official title:
Keyhole Limpet Hemocyanin in Chronic Hepatitis C and Compensated Cirrhosis - Pilot Study IM1

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01509391
Other study ID # HCVGRZ-IM1
Secondary ID
Status Completed
Phase N/A
First received January 9, 2012
Last updated October 16, 2012
Start date January 2012
Est. completion date October 2012

Study information
Verified date October 2012
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority Austria: Federal Office for Safety in Health Care
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date October 2012
Est. primary completion date October 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• keyhole-limpet hemocyanin
Subcutaneous administration keyhole-limpet hemocyanin

Locations
Country Name City State
Austria Medical University of Graz Graz

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hepatitis C viral load at week 24 24 weeks No
Secondary Hepatitis c viral load at weeks 1,2,4,8,12,18,32 1,2,4,8,12,18,32 weeks No
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