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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

Tracking Information
First Submitted Date  ICMJE January 9, 2012
First Posted Date  ICMJE January 13, 2012
Last Update Posted Date October 17, 2012
Study Start Date  ICMJE January 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
Hepatitis C viral load at week 24 [ Time Frame: 24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
Hepatitis c viral load at weeks 1,2,4,8,12,18,32 [ Time Frame: 1,2,4,8,12,18,32 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Keyhole Limpet Hemocyanin in Chronic Hepatitis C
Official Title  ICMJE Keyhole Limpet Hemocyanin in Chronic Hepatitis C and Compensated Cirrhosis - Pilot Study IM1
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Hepatitis C
  • Liver Cirrhosis
Intervention  ICMJE Drug: keyhole-limpet hemocyanin
Subcutaneous administration keyhole-limpet hemocyanin
Study Arms  ICMJE Experimental: Keyhole-limpet hemocyanine
Intervention: Drug: keyhole-limpet hemocyanin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2012)
14
Original Estimated Enrollment  ICMJE
 (submitted: January 12, 2012)
15
Actual Study Completion Date  ICMJE October 2012
Actual Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01509391
Other Study ID Numbers  ICMJE HCVGRZ-IM1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rudolf Stauber, MD, Medical University of Graz
Study Sponsor  ICMJE Medical University of Graz
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rudolf E Stauber, MD Medical University of Graz
PRS Account Medical University of Graz
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP