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Keyhole Limpet Hemocyanin in Chronic Hepatitis C (IM1)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01509391
First Posted: January 13, 2012
Last Update Posted: October 17, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rudolf Stauber, MD, Medical University of Graz
  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: Intervention Model: Single Group Assignment
Masking: None (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:


Further study details as provided by Rudolf Stauber, MD, Medical University of Graz:

Primary Outcome Measures:
  • Hepatitis C viral load at week 24 [ Time Frame: 24 weeks ]

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 ]

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

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 9, 2012
First Posted: January 13, 2012
Last Update Posted: October 17, 2012
Last Verified: October 2012

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Fibrosis
Liver Cirrhosis
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