Keyhole Limpet Hemocyanin in Chronic Hepatitis C (IM1)

Medical University of Graz

Status: Completed

Conditions: Liver Cirrhosis; Chronic Hepatitis C

Treatments: Drug: keyhole-limpet hemocyanin

Study type: Interventional

Funder types: Other

Identifiers

NCT01509391

HCVGRZ-IM1

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Keyhole-limpet hemocyanine

Experimental group

Treatment:

Drug: keyhole-limpet hemocyanin