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Trial record 1 of 2 for:    KLH | First posted from 01/01/2012 to 01/29/2012
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Keyhole Limpet Hemocyanin in Chronic Hepatitis C (IM1)

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ClinicalTrials.gov Identifier: NCT01509391
Recruitment Status : Completed
First Posted : January 13, 2012
Last Update Posted : October 17, 2012
Sponsor:
Information provided by (Responsible Party):
Rudolf Stauber, MD, Medical University of Graz

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Chronic Hepatitis C Liver Cirrhosis Drug: keyhole-limpet hemocyanin Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: N/A
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
Study Start Date : January 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Keyhole-limpet hemocyanine Drug: keyhole-limpet hemocyanin
Subcutaneous administration keyhole-limpet hemocyanin


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

Secondary Outcome Measures :
  1. Hepatitis c viral load at weeks 1,2,4,8,12,18,32 [ Time Frame: 1,2,4,8,12,18,32 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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
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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
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Austria
Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Rudolf E Stauber, MD Medical University of Graz
More Information
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Responsible Party: Rudolf Stauber, MD, Univ. Prof. Dr., Medical University of Graz
ClinicalTrials.gov Identifier: NCT01509391    
Other Study ID Numbers: HCVGRZ-IM1
First Posted: January 13, 2012    Key Record Dates
Last Update Posted: October 17, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Keyhole-limpet hemocyanin
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Pathologic Processes
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs