Role of Heme Oxygenase in the Pathogenesis of Hepatocellular Injury in Chronic Hepatitis C Virus (HCV) Infection
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ClinicalTrials.gov Identifier: NCT00842205 |
Recruitment Status : Unknown
Verified February 2009 by Charles University, Czech Republic.
Recruitment status was: Recruiting
First Posted : February 12, 2009
Last Update Posted : February 12, 2009
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Condition or disease | Intervention/treatment | Phase |
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Chronic HCV Infection Nonalcoholic Steatohepatitis | Drug: pegylated interferon Drug: Ribavarin | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Basic Science |
Official Title: | Role of Heme Oxygenase in the Pathogenesis od Hepatocellular Injury in Chronic HCV Infection |
Study Start Date : | January 2007 |
Estimated Primary Completion Date : | June 2009 |
Estimated Study Completion Date : | December 2009 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1 HCV positive pts
Patients with chronic HCV infection undergoing liver biopsy followed by antiviral treatment. peg-IFN alfa 2a 180ug s.c. QW + ribavirin 1000-1200mg p.o. daily 48weeks or peg-IFN alfa 2b 1.5 ug/kg s.c. QW + ribavirin 100-1200mg p.o. daily 48 weeks |
Drug: pegylated interferon
peg-IFN alfa 2a 180ug s.c. QW or peg-IFN alfa 2b 1.5 ug/kg s.c. QW
Other Names:
Drug: Ribavarin ribavirin 1000-1200mg p.o. daily 48weeks or ribavirin 100-1200mg p.o. daily 48 weeks
Other Names:
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No Intervention: 2 Other liver disease
pts. with NASH (or other liver disease) undergoing liver biopsy.
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- 1. the relation between HO activity and basic virologic and histologic parameters in chronic HCV patients. 2. changes of HO activity within antiviral treatment 3. relation of HO gene polymorphisms to the course of disease [ Time Frame: from HCV transmission in each individual patient to the time of liver biopsy and begining of antiviral treatment ]
- Relation of HO gene polymorphisms and UGT1A1*28 polymorphism. [ Time Frame: 3 years ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- chronic HCV infection
- must undergo liver biopsy
- must undergo antiviral treatment
Exclusion Criteria:
- liver sample not obtained
- blood samples for HCV testing not obtained in specified time points during antiviral therapy

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): NCT00842205
Czech Republic | |
Cetral Military Hospital | Recruiting |
Prague, Czech Republic, 16202 | |
Contact: Petr Urbanek, Doc., MD, CSc +420973203049 petr.urbanek@uvn.cz | |
Principal Investigator: Petr Urbanek, Doc., MD, CSc |
Responsible Party: | Petr Urbanek, Doc. MUDr., CSc, Dept of Internal Medicine, 1st Medical Faculty Charles University and Central Military Hospital Prague, Czech Republic |
ClinicalTrials.gov Identifier: | NCT00842205 |
Other Study ID Numbers: |
IGA MZ CR NR9412-3 |
First Posted: | February 12, 2009 Key Record Dates |
Last Update Posted: | February 12, 2009 |
Last Verified: | February 2009 |
hepatitis C NASH Hem Oxygenase Gene polymorphism |
Infections Communicable Diseases Hepatitis C Fatty Liver Non-alcoholic Fatty Liver Disease Disease Attributes Pathologic Processes Blood-Borne Infections Hepatitis, Viral, Human Virus Diseases |
Flaviviridae Infections RNA Virus Infections Hepatitis Liver Diseases Digestive System Diseases Interferons Antineoplastic Agents Antiviral Agents Anti-Infective Agents |