HCV InfectionPhase 3PEGARINCT00221624
Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients
A Phase 3 study testing Peginterferon alfa-2a, ribavirin and amantadine in people with HCV Infection and Hepatitis C, Chronic, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HCV Infection, Hepatitis C, Chronic
- What is being tested?
- Peginterferon alfa-2a, ribavirin and amantadine
- How many people
- 131 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2001to Apr 2004
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hepatitis C
- Previously treated with a combination of interferon plus ribavirin for at least 24 weeks
- Detectable HCV RNA (i.e. non responders)
- Signed informed consent
Who cannot join
- Evidence of another cause of liver disease
- Liver cirrhosis (child-Pugh stage BMC)
- Alcohol consumption > 30g/day for women or > 40g/day for men ; drug abuse
- Other serious relevant disorders : psychiatric condition (especially depression), cardio-vascular disease, renal decompensation, seizure history, hemoglobinopathy, auto-immune disease
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan
Pessac, 33604
About this study
Official title: Randomized Placebo-Controlled Trial of a Triple Therapy Combining Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine Versus Peginterferon Alfa-2a Plus Ribavirin Plus Placebo in Hepatitis C-Infected Patients Non Responders to a First-Line Therapy of Interferon and Ribavirin
Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C.
Read the detailed description
Background : Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C.
Design : randomized, double-blind, multicenter trial.
Interventions compared : Peg-interferon alfa 2A + ribavirin + amantadine versus Peg-interferon alfa 2A + ribavirin + Placebo
Eligibility criteria : Chronic hepatitis C, previously treated with combination of interferon plus ribavirin for at least 24 weeks,detectable HCV RNA.
primary outcome : sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment.
- Conditions
- HCV Infection, Hepatitis C, Chronic
- Being tested
- Peginterferon alfa-2a, ribavirin, amantadine
- Keywords
- Hepatitis C, chronic, HCV infection, Treatment failure, PEG Interferon, (Interferons/therapeutic use, Interferon Alfa-2a/adverse effects), ribavirin, (Ribavirin/therapeutic use, Ribavirin/adverse effects), Amantadine, Drug Therapy, Combination
- Medical subject headings
- Hepatitis C, Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon alfa-2aDrug
ribavirinDrug
amantadineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment (i.e. overall 72 weeks after randomization)
Measured: 24 weeks after the end of antiHCV treatment
Secondary outcomes (4)
ALT < upper limit of normal values,
Measured: 24 weeks after the end of anti-HCV treatment
histological response according to METAVIR score
Measured: 24 weeks after the end of anti-HCV treatment
adverse effects
quality of life assessed
Measured: at week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2001
- Study completionApr 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Patrice Couzigou, Pr, Principal investigator, University Hospital, BordeauxGeneviève Chêne, Pr, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221624
- Sponsor's protocol ID
- 7929-01
- Other IDs
- 2000-030
- Acronym
- PEGARI
- Status last verified
- Jun 2007
- First submitted
- 13 Sep 2005
- Last updated
- 13 Jun 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-Controlled Trial of a Triple Therapy Combining Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine Versus Peginterferon Alfa-2a Plus Ribavirin Plus Placebo in Hepatitis C-Infected Patients Non Responders to a First-Line Therapy of Interferon and Ribavirin
- ClinicalTrials.gov ID
- NCT00221624
- Acronym / sponsor ID
- PEGARI / 7929-01
- Conditions
- HCV Infection, Hepatitis C, Chronic
- Keywords
- Hepatitis C, chronic, HCV infection, Treatment failure, PEG Interferon, (Interferons/therapeutic use, Interferon Alfa-2a/adverse effects), ribavirin, (Ribavirin/therapeutic use
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Nov 2001
- Study completion
- Apr 2004 (actual)
- First posted
- 22 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.
Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C.
Detailed description
Background : Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C.
Design : randomized, double-blind, multicenter trial.
Interventions compared : Peg-interferon alfa 2A + ribavirin + amantadine versus Peg-interferon alfa 2A + ribavirin + Placebo
Eligibility criteria : Chronic hepatitis C, previously treated with combination of interferon plus ribavirin for at least 24 weeks,detectable HCV RNA.
primary outcome : sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic hepatitis C
- Previously treated with a combination of interferon plus ribavirin for at least 24 weeks
- Detectable HCV RNA (i.e. non responders)
- Signed informed consent
Key exclusion criteria (4 listed)
- Evidence of another cause of liver disease
- Liver cirrhosis (child-Pugh stage BMC)
- Alcohol consumption > 30g/day for women or > 40g/day for men ; drug abuse
- Other serious relevant disorders : psychiatric condition (especially depression), cardio-vascular disease, renal decompensation, seizure history, hemoglobinopathy, auto-immune disease
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 |
|---|---|---|
| Peginterferon alfa-2a | Drug | – |
| ribavirin | Drug | – |
| amantadine | Drug | – |
Primary outcome
sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment (i.e. overall 72 weeks after randomization)
Time frame: 24 weeks after the end of antiHCV treatment
4 secondary outcomes
ALT < upper limit of normal values,
Time frame: 24 weeks after the end of anti-HCV treatment
histological response according to METAVIR score
Time frame: 24 weeks after the end of anti-HCV treatment
adverse effects
quality of life assessed
Time frame: at week 72
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 Jun 2007.
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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.
Patrice Couzigou, Pr principal investigator
University Hospital, Bordeaux
Geneviève Chêne, Pr study chair
University Hospital, Bordeaux
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 Peginterferon alfa-2a, ribavirin and amantadine in people with HCV Infection and Hepatitis C, Chronic, run by University Hospital, Bordeaux 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 4 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 13 Jun 2007. 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. 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?
sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment (i.e. overall 72 weeks after randomization) (time frame: 24 weeks after the end of antiHCV treatment). 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 13 Jun 2007.