Chronic Hepatitis CPhase 4NCT00298714
Effects of Losartan on Hepatic Fibrogenesis in Chronic Hepatitis C
A Phase 4 study testing Losartan in people with Chronic Hepatitis C and Liver Fibrosis, run by Hospital Clinic of Barcelona.
Trial summary
There is evidence on the beneficial effects of the administration of angiotensin II type 1 (AT1) receptors antagonists on liver fibrosis in hepatic stellate cells, experimental models of liver fibrosis in rodents and limited information in chronic hepatitis C with mild fibrosis. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Chronic Hepatitis C, Liver Fibrosis
- What is being tested?
- Losartan
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Jan 2006
- Phase
- Phase 4
- 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 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 35 and 65 years
- chronic hepatitis C with intermediate fibrosis (F2-F3 in Metavir score).
- non-responder or contraindication to antiviral therapy.
Who cannot join
- any other cause of liver disease
- HIV positive
- alcohol consumption
- arterial hypertension
- creatinine > 1.5mg/dL
- treatment with AT1 receptor antagonists or angiotensin converting enzyme inhibitors in the past 12 months.
- antiviral therapy in the past 12 months
- contraindications to oral losartan
About this study
Official title: Effect of Long-Term Administration of Oral Losartan on Hepatic Fibrogenesis and Gene Expression in Chronic Hepatitis C With Significant Liver Fibrosis.
There is evidence on the beneficial effects of the administration of angiotensin II type 1 (AT1) receptors antagonists on liver fibrosis in hepatic stellate cells, experimental models of liver fibrosis in rodents and limited information in chronic hepatitis C with mild fibrosis.
The purpose of this study is to investigate the effect of long-term administration of oral Losartan, an AT1 receptor antagonist, on liver fibrogenesis in patients with chronic hepatitis C and fibrosis F2-F3 (METAVIR score).
- Conditions
- Chronic Hepatitis C, Liver Fibrosis
- Being tested
- Losartan
- Keywords
- Hepatitis C, Chronic
- Medical subject headings
- Hepatitis C, Chronic, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LosartanDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of liver fibrogenesis by changes in gene expression of key mediators of liver fibrosis.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2006 (estimated)
- Study startMar 2003
- Study completionJan 2006
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 Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Investigators
- Pere Ginès, M.D., Principal investigator, Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, BarcelonaVicente Arroyo, M.D., Study chair, Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00298714
- Sponsor's protocol ID
- ARAHEPC
- Other IDs
- Protocol number: 02-0491
- Status last verified
- Nov 2007
- First submitted
- 2 Mar 2006
- Last updated
- 22 Nov 2007
- Results posted
- No
Publications
Colmenero J, Bataller R, Sancho-Bru P, Dominguez M, Moreno M, Forns X, Bruguera M, Arroyo V, Brenner DA, Gines P. Effects of losartan on hepatic expression of nonphagocytic NADPH oxidase and fibrogenic genes in patients with chronic hepatitis C. Am J Physiol Gastrointest Liver Physiol. 2009 Oct;297(4):G726-34. doi: 10.1152/ajpgi.00162.2009. Epub 2009 Jul 23.
PubMed 19628656
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Long-Term Administration of Oral Losartan on Hepatic Fibrogenesis and Gene Expression in Chronic Hepatitis C With Significant Liver Fibrosis.
- ClinicalTrials.gov ID
- NCT00298714
- Acronym / sponsor ID
- ARAHEPC
- Conditions
- Chronic Hepatitis C, Liver Fibrosis
- Keywords
- Hepatitis C, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Mar 2003
- Study completion
- Jan 2006 (actual)
- First posted
- 3 Mar 2006 (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.
There is evidence on the beneficial effects of the administration of angiotensin II type 1 (AT1) receptors antagonists on liver fibrosis in hepatic stellate cells, experimental models of liver fibrosis in rodents and limited information in chronic hepatitis C with mild fibrosis.
The purpose of this study is to investigate the effect of long-term administration of oral Losartan, an AT1 receptor antagonist, on liver fibrogenesis in patients with chronic hepatitis C and fibrosis F2-F3 (METAVIR score).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age between 35 and 65 years
- chronic hepatitis C with intermediate fibrosis (F2-F3 in Metavir score).
- non-responder or contraindication to antiviral therapy.
Key exclusion criteria (8 listed)
- any other cause of liver disease
- HIV positive
- alcohol consumption
- arterial hypertension
- creatinine > 1.5mg/dL
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Losartan | Drug | – |
Primary outcome
Assessment of liver fibrogenesis by changes in gene expression of key mediators of liver fibrosis.
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 22 Nov 2007.
- Derived from this study: PubMed 19628656Colmenero J, Bataller R, Sancho-Bru P, Dominguez M, Moreno M, Forns X, Bruguera M, Arroyo V, Brenner DA, Gines P. Effects of losartan on hepatic expression of nonphagocytic NADPH oxidase and fibrogenic genes in patients with chronic hepatitis C. Am J Physiol Gastrointest Liver Physiol. 2009 Oct;297(4):G726-34. doi: 10.1152/ajpgi.00162.2009. Epub 2009 Jul 23.
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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.
Pere Ginès, M.D. principal investigator
Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona
Vicente Arroyo, M.D. study chair
Liver Unit, Institut Clínic de Malalties Digestives, Hospital Clínic, Barcelona
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Losartan in people with Chronic Hepatitis C and Liver Fibrosis, run by Hospital Clinic of Barcelona.
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 3 inclusion and 8 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 22 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assessment of liver fibrogenesis by changes in gene expression of key mediators of liver fibrosis.. 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 NCT00298714, 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 22 Nov 2007.