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Keyhole Limpet Hemocyanin in Chronic Hepatitis C (IM1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rudolf Stauber, MD, Medical University of Graz
ClinicalTrials.gov Identifier:
NCT01509391
First received: January 9, 2012
Last updated: October 16, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Chronic Hepatitis C
Liver Cirrhosis
 Drug: keyhole-limpet hemocyanin

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Keyhole Limpet Hemocyanin in Chronic Hepatitis C and Compensated Cirrhosis - Pilot Study IM1

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Hepatitis C viral load at week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hepatitis c viral load at weeks 1,2,4,8,12,18,32 [ Time Frame: 1,2,4,8,12,18,32 weeks ] [ Designated as safety issue: No ]

Enrollment: 14
Study Start Date: January 2012
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Keyhole-limpet hemocyanine Drug: keyhole-limpet hemocyanin
Subcutaneous administration keyhole-limpet hemocyanin

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509391

Locations
Austria
Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Principal Investigator: Rudolf E Stauber, MD Medical University of Graz
  More Information

No publications provided

Responsible Party: Rudolf Stauber, MD, Univ. Prof. Dr., Medical University of Graz
ClinicalTrials.gov Identifier: NCT01509391     History of Changes
Other Study ID Numbers: HCVGRZ-IM1
Study First Received: January 9, 2012
Last Updated: October 16, 2012
Health Authority: Austria: Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Liver Cirrhosis
Fibrosis
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Keyhole-limpet hemocyanin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013