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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00000813 |
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Date of registration:
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27/04/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of selenium levels in HCV- infected patients at different stages of disease
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Scientific title:
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Comparison of selenium levels in HCV- infected patients at different stages of disease |
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Date of first enrolment:
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13/04/2011 |
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Target sample size:
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40 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00000813 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: treatment
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Hans Christian
Spangenberg |
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Address:
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Hugstetter Str. 55
79106
Freiburg
Germany |
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Telephone:
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+49 76127034010 |
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Email:
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dominik.bettinger@uniklinik-freiburg.de |
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Affiliation:
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UKL Freiburg |
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Name:
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Hans Christian
Spangenberg |
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Address:
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Hugstetter Str. 55
79100
Freiburg
Germany |
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Telephone:
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0761-270-34010 |
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Email:
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hans.spangenberg@uniklinik-freiburg.de |
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Affiliation:
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UKL Freiburg, Med. Klinik II |
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Key inclusion & exclusion criteria
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Inclusion criteria: a) patients with chronic hepatitis c- infection: no cirrhosis of the liver (= Desmet IV), no HCC - suspected lesion in the liver
b) patients with hcv- associated cirrhosis of the liver: - cirrhosis of the liver confirmed by ultrasound, CT/MRI imaging or biopsy, all child - stages
c) patients with hcv- associated HCC: diagnosis of HCC according to the AASLD criteria, HCC has not been treated at the time of enrollment, all BCLC- /UICC- stages.
d) for all three groups: diagnosis of the chronic hcv- infection with virus rna and serologic parameters (anti-hcv) and abnormal liver function for more than 6 months, no antiviral treatment during the last 6 months
Exclusion criteria: - application of dietary supplements
- excessive alcohol consumption
- all other etiologies leading to a liver injury
- patients with an acute-phase- reaction (SIRS, sepsis, patients in intensive care units)
- extrahepatic neoplasm
- rheumatic disease apart from hcv- associated immunologic phenomena
- diabetes mellitus I and II
- immunological diseases
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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C22.0
K73.9
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C22.0
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K73.9
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Liver cell carcinoma
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Chronic hepatitis, unspecified
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Intervention(s)
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Group 1: observation group: patients with cronic hcv- infection without cirrhosis of the liver and without HCC (10 patients)
Group 2: observation group: patients with hcv- infection with cirrhosis of the liver, but without HCC (10 patients)
Group 3: observation group: patients with hcv- infection with HCC (10 patients)
Group 4: observation group: healthy controls (10 controls)
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Primary Outcome(s)
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comparison of the selenium levels in these 4 groups
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Secondary Outcome(s)
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- selenium levels and inflammatory activity
- selenium levels and stadium of HCC
- selenium levels and MELD(Na)score
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Secondary ID(s)
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NCT01355107
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Source(s) of Monetary Support
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UKL Freiburg, Med. Klinik II
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Ethics review
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Status: Approved
Approval date: 13/04/2011
Contact:
ekfr.mpg@uniklinik-freiburg.de
Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
+49-761-27072600
ekfr.mpg@uniklinik-freiburg.de
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