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Keyhole Limpet Hemocyanin in Chronic Hepatitis C

NCT ID: NCT01509391

Last Updated: 2012-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-10-31

Brief Summary

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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

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Conditions

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Chronic Hepatitis C Liver Cirrhosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Keyhole-limpet hemocyanine

Group Type EXPERIMENTAL

keyhole-limpet hemocyanin

Intervention Type DRUG

Subcutaneous administration keyhole-limpet hemocyanin

Interventions

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keyhole-limpet hemocyanin

Subcutaneous administration keyhole-limpet hemocyanin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Graz

OTHER

Sponsor Role lead

Responsible Party

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Rudolf Stauber, MD

Univ. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rudolf E Stauber, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Graz

Locations

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Medical University of Graz

Graz, , Austria

Site Status

Countries

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Austria

Other Identifiers

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HCVGRZ-IM1

Identifier Type: -

Identifier Source: org_study_id