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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Liver Cirrhosis
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Keyhole-limpet hemocyanin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014