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

Keyhole Limpet Hemocyanin in Chronic Hepatitis C

Sponsors

Lead sponsor: Medical University of Graz

Source 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.

Overall Status Completed
Start Date January 2012
Completion Date October 2012
Primary Completion Date October 2012
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Hepatitis C viral load at week 24 24 weeks
Secondary Outcome
Measure Time Frame
Hepatitis c viral load at weeks 1,2,4,8,12,18,32 1,2,4,8,12,18,32 weeks
Enrollment 14
Condition
Intervention

Intervention type: Drug

Intervention name: keyhole-limpet hemocyanin

Description: Subcutaneous administration keyhole-limpet hemocyanin

Arm group label: Keyhole-limpet hemocyanine

Eligibility

Criteria:

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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Rudolf E Stauber, MD Principal Investigator Medical University of Graz
Location
facility Medical University of Graz
Location Countries

Austria

Verification Date

October 2012

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Medical University of Graz

Investigator full name: Rudolf Stauber, MD

Investigator title: Univ. Prof. Dr.

Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Arm group label: Keyhole-limpet hemocyanine

Arm group type: Experimental

Acronym IM1
Study Design Info

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov