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Keyhole Limpet Hemocyanin in Chronic Hepatitis C (IM1)

Primary Purpose

Chronic Hepatitis C, Liver Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
keyhole-limpet hemocyanin
Sponsored by
Medical University of Graz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Graz

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Keyhole-limpet hemocyanine

Arm Description

Outcomes

Primary Outcome Measures

Hepatitis C viral load at week 24

Secondary Outcome Measures

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

Full Information

First Posted
January 9, 2012
Last Updated
October 16, 2012
Sponsor
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT01509391
Brief Title
Keyhole Limpet Hemocyanin in Chronic Hepatitis C
Acronym
IM1
Official Title
Keyhole Limpet Hemocyanin in Chronic Hepatitis C and Compensated Cirrhosis - Pilot Study IM1
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Graz

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, Liver Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Keyhole-limpet hemocyanine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
keyhole-limpet hemocyanin
Intervention Description
Subcutaneous administration keyhole-limpet hemocyanin
Primary Outcome Measure Information:
Title
Hepatitis C viral load at week 24
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Hepatitis c viral load at weeks 1,2,4,8,12,18,32
Time Frame
1,2,4,8,12,18,32 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rudolf E Stauber, MD
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria

12. IPD Sharing Statement

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Keyhole Limpet Hemocyanin in Chronic Hepatitis C

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