Hepatitis C, ChronicPhase 2PRAZORNCT00148837
Efficacy of Prazosin Versus Placebo Associated With Peg-interferon Alpha 2b and Ribavirin in Chronic Hepatitis C With Genotype 1 or 4 and Severe Fibrosis
A Phase 2 study testing Peg-interferon alpha 2b + Ribavirin(drug) and Prazosin (drug) in people with Hepatitis C, Chronic and Fibrosis, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial summary
Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. The study will evaluate the efficacy of prazosin to make hepatic fibrosis regress, in patients with chronic hepatitis C and severe fibrosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic, Fibrosis
- What is being tested?
- Peg-interferon alpha 2b + Ribavirin(drug) and Prazosin (drug)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2004to Dec 2008
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic viral hepatitis C, genotype 1 or 4
- Fibrosis F3 or F3-F4, assessed by the scoring Metavir system
- Initial treatment against HCV
Who cannot join
- Psychiatric pathology
- Alcool consummation
- Pregnancy or plan of pregnancy
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double Blind Trial Comparing the Efficacy of Prazosin Versus Placebo Associated With Peg-interferon Alpha 2b and Ribavirin for Initial Treatment of Patients With Hepatitis C With Genotype 1 or 4 and Severe Fibrosis (ANRS HC17 PRAZOR)
Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. The study will evaluate the efficacy of prazosin to make hepatic fibrosis regress, in patients with chronic hepatitis C and severe fibrosis.
Read the detailed description
Treatment of hepatitis C with interferon and ribavirin has a virological effect. Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. In vitro studies of prazosin suggest an effect against hepatic fibrosis, but the clinical effect of prazosin on the hepatic fibrosis induced by hepatitis C infection is unknown. The purpose of this multicentric national study is to compare the effects among the hepatic fibrosis of peg-interferon alpha 2b and ribavirin with prazosin or not (placebo). 112 patients with a viral hepatitis C, genotype 1 or 4, and severe fibrosis, will be randomly assigned to one of two treatment groups: peg-interferon alpha 2b and ribavirin, with prazosin or with placebo. Peg-interferon alpha 2b will be administered once a week (1.5 micro g per kg) during 48 weeks, ribavirin 1,000 to 1,200 mg per day (according to weight) during 48 weeks, prazosin/placebo 5 mg (2 pills) per day during 96 weeks. Evaluation will be done at 96 weeks. The primary end-point is the proportion of patients presenting a decrease of fibrosis. Secondary end-points are other criteria of histological response, virological response, biochemical response.
- Conditions
- Hepatitis C, Chronic, Fibrosis
- Being tested
- Peg-interferon alpha 2b + Ribavirin(drug), Prazosin (drug)
- Keywords
- Hepatitis C, Chronic, Fibrosis, Interferon Alfa-2b, Ribavirin, Prazosin
- Medical subject headings
- Hepatitis C, Chronic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peg-interferon alpha 2b + Ribavirin(drug)Drug
Prazosin (drug)Drug
one to two capsules 2.5 mg per day
| Study group | Role | What they receive |
|---|---|---|
| prazosin | Experimental | PegInterferon alfa-2b + Ribavirin + Prazosin Receives: Drug: Peg-interferon alpha 2b + Ribavirin(drug); Drug: Prazosin (drug) |
| placebo | Placebo comparator | PegInterféron alfa-2b + Ribavirin + placebo Receives: Drug: Peg-interferon alpha 2b + Ribavirin(drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients presenting a decrease of fibrosis as measured on the liver biopsy and considered as clinically interesting (decrease of fibrosis pre- and post-therapeutic (W96) measures of at least 10 percent)
Measured: W96
Secondary outcomes (3)
Metavir scoring system; immunostaining of alpha-smooth muscle actin; indirect markers of fibrosis (Fibrotest) at W96
Measured: W96
Sustained virological response: undetectable HCV RNA at W96
Measured: W96
Sustained biochemical response: ALT level at W96
Measured: W96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- de Ledinghen Victor, MD, PhD, Principal investigator, Hopital du Haut-Leveque, Service d'Hepato-Gastroenterologie, Pessac 33604, FranceChene Genevieve, MD, PhD, Study director, INSERM Unite 593, Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148837
- Sponsor's protocol ID
- ANRS HC17 PRAZOR
- Other IDs
- 2004-001326-24, 2004
- Acronym
- PRAZOR
- Status last verified
- Feb 2008
- First submitted
- 7 Sep 2005
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Trial Comparing the Efficacy of Prazosin Versus Placebo Associated With Peg-interferon Alpha 2b and Ribavirin for Initial Treatment of Patients With Hepatitis C With Genotype 1 or 4 and Severe Fibrosis (ANRS HC17 PRAZOR)
- ClinicalTrials.gov ID
- NCT00148837
- Acronym / sponsor ID
- PRAZOR / ANRS HC17 PRAZOR
- Conditions
- Hepatitis C, Chronic, Fibrosis
- Keywords
- Hepatitis C, Chronic, Fibrosis, Interferon Alfa-2b, Ribavirin, Prazosin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- Pfizer
- Study start
- Sep 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 8 Sep 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.
Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. The study will evaluate the efficacy of prazosin to make hepatic fibrosis regress, in patients with chronic hepatitis C and severe fibrosis.
Detailed description
Treatment of hepatitis C with interferon and ribavirin has a virological effect. Viral hepatitis C prognosis is related to the presence of a fibrosis and to the risk of developing cirrhosis or hepatic cancer. In vitro studies of prazosin suggest an effect against hepatic fibrosis, but the clinical effect of prazosin on the hepatic fibrosis induced by hepatitis C infection is unknown. The purpose of this multicentric national study is to compare the effects among the hepatic fibrosis of peg-interferon alpha 2b and ribavirin with prazosin or not (placebo). 112 patients with a viral hepatitis C, genotype 1 or 4, and severe fibrosis, will be randomly assigned to one of two treatment groups: peg-interferon alpha 2b and ribavirin, with prazosin or with placebo. Peg-interferon alpha 2b will be administered once a week (1.5 micro g per kg) during 48 weeks, ribavirin 1,000 to 1,200 mg per day (according to weight) during 48 weeks, prazosin/placebo 5 mg (2 pills) per day during 96 weeks. Evaluation will be done at 96 weeks. The primary end-point is the proportion of patients presenting a decrease of fibrosis. Secondary end-points are other criteria of histological response, virological response, biochemical response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| prazosin | Experimental | Drug: Peg-interferon alpha 2b + Ribavirin(drug), Drug: Prazosin (drug)PegInterferon alfa-2b + Ribavirin + Prazosin |
| placebo | Placebo comparator | Drug: Peg-interferon alpha 2b + Ribavirin(drug)PegInterféron alfa-2b + Ribavirin + placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic viral hepatitis C, genotype 1 or 4
- Fibrosis F3 or F3-F4, assessed by the scoring Metavir system
- Initial treatment against HCV
Key exclusion criteria (4 listed)
- Psychiatric pathology
- Alcool consummation
- Pregnancy or plan of pregnancy
- Breastfeeding
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 |
|---|---|---|
| Peg-interferon alpha 2b + Ribavirin(drug) | Drug | placebo, prazosin |
| Prazosin (drug)one to two capsules 2.5 mg per day | Drug | prazosin |
Primary outcome
Proportion of patients presenting a decrease of fibrosis as measured on the liver biopsy and considered as clinically interesting (decrease of fibrosis pre- and post-therapeutic (W96) measures of at least 10 percent)
Time frame: W96
3 secondary outcomes
Metavir scoring system; immunostaining of alpha-smooth muscle actin; indirect markers of fibrosis (Fibrotest) at W96
Time frame: W96
Sustained virological response: undetectable HCV RNA at W96
Time frame: W96
Sustained biochemical response: ALT level at W96
Time frame: W96
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 15 Jun 2026.
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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.
de Ledinghen Victor, MD, PhD principal investigator
Hopital du Haut-Leveque, Service d'Hepato-Gastroenterologie, Pessac 33604, France
Chene Genevieve, MD, PhD study director
INSERM Unite 593, Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peg-interferon alpha 2b + Ribavirin(drug) and Prazosin (drug) in people with Hepatitis C, Chronic and Fibrosis, run by French National Agency for Research on AIDS and Viral Hepatitis 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 3 inclusion and 4 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 15 Jun 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Proportion of patients presenting a decrease of fibrosis as measured on the liver biopsy and considered as clinically interesting (decrease of fibrosis pre- and post-therapeutic (W96) measures of at least 10 percent) (time frame: W96). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.