Keyhole Limpet Hemocyanin in Chronic Hepatitis C (IM1)

M

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)

14 participants in 1 patient group

Keyhole-limpet hemocyanine
Experimental group
Treatment:
Drug: keyhole-limpet hemocyanin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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