Hepatitis C, ChronicNCT01112033
Biliverdin Reductase A in Chronic Hepatitis C Virus Infection
An observational study of Hepatitis C, Chronic, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
In this project, the investigators aim to study the role of biliverdin reductase A (BLVRA) in HCV infected patients prior and during/after standard antiviral therapy in association with viral clearance, disease progression and treatment response and in comparison with healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Chronic
- How many people
- 113 participants
- Where
- 1 siteCzechia
- Study dates
- Jun 2010to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Estimated enrollment: BLVRA expression study: 50 - 100 HCV patients 50 healthy volunteers Polymorphisms of BLVRA study: 300 HCV patients
Who may be able to join
- BLVRA expression study
- Therapeutically naïve HCV patients undergoing antiviral treatment with peg-interferon plus ribavirin combination therapy
- BLVRA genetic polymorphisms study
- HCV infected patients prior, during, after or without antiviral therapy
Who cannot join
- Co-infection with HAV, HBV and HIV
- Disorders of heme metabolism
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Institute of Clinical Biochemistry and Laboratory Diagnostics, First Faculty of Medicine, Charles University in Prague
Prague, 128 60
About this study
In this project, the investigators aim to study the role of biliverdin reductase A (BLVRA) in HCV infected patients prior and during/after standard antiviral therapy in association with viral clearance, disease progression and treatment response and in comparison with healthy subjects.
Read the detailed description
- To analyze biliverdin reductase (BLVRA) expression in the liver of HVC infected patients undergoing liver biopsy followed by standard antiviral treatment (peg-interferon plus ribavirin combination therapy) and patients with other forms of liver diseases undergoing liver biopsy as controls.
- To analyze BLVRA expression in peripheral blood leukocytes (PBL) of therapeutically naïve HCV patients, during/after standard antiviral therapy and healthy controls.
- To analyze BVLRA genetic polymorphisms both in HCV infected patients and healthy controls.
- Conditions
- Hepatitis C, Chronic
- Keywords
- biliverdin reductase, BLVRA, hepatitis C, HCV, peripheral blood mononuclear cells, PBMC, liver, genetic polymorphisms
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chronic HCV infection | The study was performed on therapeutically naïve patients with chronic HCV infection. Patients with positivity of anti-HCV antibodies, and detectable HCV RNA in serum for at least 6 months, were included in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess differences in BLVRA expression in the liver and PBMC in HCV infected patients in responders and non-responders to standard antiviral therapy.
Measured: 72 weeks
Secondary outcomes (1)
To analyze the association of genetic polymorphisms of BLVRA with disease progression and treatment response in HCV infected patients.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionMar 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- Military University Hospital, Prague, General University Hospital, Prague, Institute for Clinical and Experimental Medicine
- Responsible party
- Principal investigator, Iva Subhanova, Charles University, Czech Republic
- Investigators
- Iva Subhanova, Principal investigator, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112033
- Sponsor's protocol ID
- BLVRA1
- Status last verified
- Aug 2015
- First submitted
- 23 Apr 2010
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Subhanova I, Muchova L, Lenicek M, Vreman HJ, Luksan O, Kubickova K, Kreidlova M, Zima T, Vitek L, Urbanek P. Expression of Biliverdin Reductase A in peripheral blood leukocytes is associated with treatment response in HCV-infected patients. PLoS One. 2013;8(3):e57555. doi: 10.1371/journal.pone.0057555. Epub 2013 Mar 11.
PubMed 23536765
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biliverdin Reductase A in Chronic Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT01112033
- Acronym / sponsor ID
- BLVRA1
- Conditions
- Hepatitis C, Chronic
- Keywords
- biliverdin reductase, BLVRA, hepatitis C, HCV, peripheral blood mononuclear cells, PBMC, liver, genetic polymorphisms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- Military University Hospital, Prague, General University Hospital, Prague, Institute for Clinical and Experimental Medicine
- Study start
- Jun 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this project, the investigators aim to study the role of biliverdin reductase A (BLVRA) in HCV infected patients prior and during/after standard antiviral therapy in association with viral clearance, disease progression and treatment response and in comparison with healthy subjects.
Detailed description
- To analyze biliverdin reductase (BLVRA) expression in the liver of HVC infected patients undergoing liver biopsy followed by standard antiviral treatment (peg-interferon plus ribavirin combination therapy) and patients with other forms of liver diseases undergoing liver biopsy as controls.
- To analyze BLVRA expression in peripheral blood leukocytes (PBL) of therapeutically naïve HCV patients, during/after standard antiviral therapy and healthy controls.
- To analyze BVLRA genetic polymorphisms both in HCV infected patients and healthy controls.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic HCV infection | – | –The study was performed on therapeutically naïve patients with chronic HCV infection. Patients with positivity of anti-HCV antibodies, and detectable HCV RNA in serum for at least 6 months, were included in the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Estimated enrollment: BLVRA expression study: 50 - 100 HCV patients 50 healthy volunteers Polymorphisms of BLVRA study: 300 HCV patients
Key inclusion criteria (4 listed)
- BLVRA expression study
- Therapeutically naïve HCV patients undergoing antiviral treatment with peg-interferon plus ribavirin combination therapy
- BLVRA genetic polymorphisms study
- HCV infected patients prior, during, after or without antiviral therapy
Key exclusion criteria (2 listed)
- Co-infection with HAV, HBV and HIV
- Disorders of heme metabolism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To assess differences in BLVRA expression in the liver and PBMC in HCV infected patients in responders and non-responders to standard antiviral therapy.
Time frame: 72 weeks
1 secondary outcome
To analyze the association of genetic polymorphisms of BLVRA with disease progression and treatment response in HCV infected patients.
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
- Results publication: PubMed 23536765Subhanova I, Muchova L, Lenicek M, Vreman HJ, Luksan O, Kubickova K, Kreidlova M, Zima T, Vitek L, Urbanek P. Expression of Biliverdin Reductase A in peripheral blood leukocytes is associated with treatment response in HCV-infected patients. PLoS One. 2013;8(3):e57555. doi: 10.1371/journal.pone.0057555. Epub 2013 Mar 11.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iva Subhanova principal investigator
Charles University, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess differences in BLVRA expression in the liver and PBMC in HCV infected patients in responders and non-responders to standard antiviral therapy. (time frame: 72 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01112033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2015.