Hepatitis C, ChronicPhase 3FibrosarNCT00265642
Evaluation of Irbesartan on Hepatic Fibrosis in Chronic Hepatitis C
A Phase 3 study testing Irbesartan in people with Hepatitis C, Chronic, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
The purpose of this study is to examine the efficacy of irbesartan on the progression of liver fibrosis in adult patients with chronic hepatitis C. The expected total enrollment is 200 patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Irbesartan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 166 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Nov 2013
- Phase
- Phase 3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age between 18 and 75 years
- liver biopsy performed (less 18 month before inclusion), fibrosis score F2,F3 or F3+ in Metavir classification,
- patients without antiviral therapy
- contraindication to anti viral treatment
- non responders or relapsers patients to past antiviral treatment
Who cannot join
- hepatocellular carcinoma
- HIV
- alcool abuser
- cirrhosis
- anti-fibrotic treatment
- pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Angers, Service d'hépato-gastroentérologie
Angers, 49933 cedex 09
About this study
Official title: Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C
The purpose of this study is to examine the efficacy of irbesartan on the progression of liver fibrosis in adult patients with chronic hepatitis C.
The expected total enrollment is 200 patients. Patients who meet the study criteria and accept to participate at this study will take by day one tablet of 150 mg of treatment (irbesartan or placebo) during two years. The assessment of efficacy will be make by evaluation of area of liver fibrosis and blood markers of liver fibrosis
Read the detailed description
The results of several studies suggests than the AT1 receptor antagonists of angiotensin II have inhibitory effects on TGF-beta 1 production and can limit the progression of liver fibrosis.
Therefore, the angiotensin II could be another mediator of the synthesis of the extra-cellular matrix at the hepatic level, opening new perspectives with the antagonists of angiotensin II receptors drugs (ARA2/sartans).
This study is a randomized, double blind, multi-center, parallel assignment, and efficacy study.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Irbesartan, placebo
- Keywords
- Hepatitis C, Chronic, irbesartan
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IrbesartanDrug
one tablet of 150 mg/d during 2 years
placeboDrug
one tablet per day during 2 years
| Study group | Role | What they receive |
|---|---|---|
| group verum | Experimental | Drug: Irbesartan Receives: Drug: Irbesartan |
| group placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24
Measured: at M24
Secondary outcomes (1)
Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry)
Measured: at M24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
- Study startOct 2006
- Primary completionApr 2013
- Study completionNov 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 ANRS, Emerging Infectious DiseasesThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Paul Cales, MD, Principal investigator, CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09Fabrice Carrat, MD, Study chair, Inserm U707 France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265642
- Sponsor's protocol ID
- ANRS HC 19 Fibrosar
- Other IDs
- 2005-006027-37, 2005
- Acronym
- Fibrosar
- Status last verified
- Apr 2026
- First submitted
- 14 Dec 2005
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cales, Paul, et al. "Irbesartan for severe fibrosis in chronic hepatitis C: a double-blind randomized trial (ANRS HC19 Fibrosar): 454." Hepatology 60 (2014): 423A-424A.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of a Sartan on Hepatic Fibrosis Progression in Chronic Viral Hepatitis C
- ClinicalTrials.gov ID
- NCT00265642
- Acronym / sponsor ID
- Fibrosar / ANRS HC 19 Fibrosar
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis C, Chronic, irbesartan
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Collaborators
- Sanofi
- Study start
- Oct 2006
- Primary completion
- Apr 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 15 Dec 2005 (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.
The purpose of this study is to examine the efficacy of irbesartan on the progression of liver fibrosis in adult patients with chronic hepatitis C.
The expected total enrollment is 200 patients. Patients who meet the study criteria and accept to participate at this study will take by day one tablet of 150 mg of treatment (irbesartan or placebo) during two years. The assessment of efficacy will be make by evaluation of area of liver fibrosis and blood markers of liver fibrosis
Detailed description
The results of several studies suggests than the AT1 receptor antagonists of angiotensin II have inhibitory effects on TGF-beta 1 production and can limit the progression of liver fibrosis.
Therefore, the angiotensin II could be another mediator of the synthesis of the extra-cellular matrix at the hepatic level, opening new perspectives with the antagonists of angiotensin II receptors drugs (ARA2/sartans).
This study is a randomized, double blind, multi-center, parallel assignment, and efficacy study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group verum | Experimental | Drug: IrbesartanDrug: Irbesartan |
| group placebo | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age between 18 and 75 years
- liver biopsy performed (less 18 month before inclusion), fibrosis score F2,F3 or F3+ in Metavir classification,
- patients without antiviral therapy
- contraindication to anti viral treatment
- non responders or relapsers patients to past antiviral treatment
Key exclusion criteria (6 listed)
- hepatocellular carcinoma
- HIV
- alcool abuser
- cirrhosis
- anti-fibrotic treatment
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 |
|---|---|---|
| Irbesartanone tablet of 150 mg/d during 2 years | Drug | group verum |
| placeboone tablet per day during 2 years | Drug | group placebo |
Primary outcome
Assessment of liver fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24
Time frame: at M24
1 secondary outcome
Assessment of liver fibrosis changes at M24 by non-invasive tests ((blood test mainly and also elastometry)
Time frame: at M24
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 13 Apr 2026.
- Results publicationCales, Paul, et al. "Irbesartan for severe fibrosis in chronic hepatitis C: a double-blind randomized trial (ANRS HC19 Fibrosar): 454." Hepatology 60 (2014): 423A-424A.
- Related InfoLink provided by the sponsor.
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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.
Paul Cales, MD principal investigator
CHU Angers, Service d'hépato-gastroentérologie, 49933 Angers Cedex 09
Fabrice Carrat, MD study chair
Inserm U707 France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Irbesartan in people with Hepatitis C, Chronic, run by ANRS, Emerging Infectious Diseases at 1 site in France.
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 5 inclusion and 6 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 13 Apr 2026. 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 France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 fibrosis changes by measurement of area of porto-septal fibrosis (morphometry)at M24 (time frame: at M24). 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 NCT00265642, 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 13 Apr 2026.