Hepatitis C, ChronicPhase 3NCT00122629
Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous Hepatitis C Virus (HCV) Non Responders
A Phase 3 study testing peg-interferon alfa-2b, ribavirin and amantadine in people with Hepatitis C, Chronic, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial summary
Triple antiviral therapy with peg-interferon-alfa/ribavirin+amantadine was suggested to increase sustained virological response (SVR) rates in HCV non-responders to a standard interferon/ribavirin combination. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- peg-interferon alfa-2b, ribavirin and amantadine
- How many people
- 405 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2000to May 2003
- 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 65 years
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive anti-HCV antibody test
- Patients who did not respond to treatment with standard interferon + ribavirin (HCV RNA+ by PCR in the last month of treatment)
- Compensated liver disease
- Neutrophil count over or equal to1000/mm3
- Platelet count over or equal to 100 giga/L
- Haemoglobin over or equal to 10g/dL
- Patients had to have undergone a post-treatment liver biopsy within a year, showing a METAVIR histological score over or equal to A1F1, without cirrhosis (fibrosis score below F4)
- ALT over N and HCV RNA+ at screening
Who cannot join
- Co-infection with hepatitis B or human immunodeficiency virus
- Any other cause of liver disease
- Active drug abuse, active alcohol consumption above 40g/day
- Organ grafts
- Presence of hepatocellular carcinoma
- Cardiovascular, metabolic, renal, haematological, neurological or psychiatric disease
- Patients with previous amantadine use
- Systemic immunosuppressive or antiviral treatment during the last 24 weeks and those with a history of interferon and/or ribavirin intolerance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous HCV Non Responders ANRSHC03 BITRI
Triple antiviral therapy with peg-interferon-alfa/ribavirin+amantadine was suggested to increase sustained virological response (SVR) rates in HCV non-responders to a standard interferon/ribavirin combination.
Patients with hepatitis C virus infection were eligible if they had failed to respond to a single previous 24 week cycle of interferon/ribavirin combination therapy. Non-response was defined as persistent HCV RNA in the serum during the last month of treatment.
This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and amantadine or a placebo for 48 weeks.
Read the detailed description
Triple antiviral therapy with peg-interferon-alfa/ribavirin + amantadine was suggested to increase sustained virological response (SVR) rates in HCV non-responders to a standard interferon/ribavirin combination.
The aim of this study is to determine if the addition of amantadine to PEG-IFN/ribavirin enhances SVR.
This study is a double blind, comparative, prospective multicenter, randomized study. Patients are recruited from 23 hepatology centers in France. The protocol was approved by the French ethical committee and all patients provided written informed consent. Eligible subjects are randomly assigned to the two treatment groups in equal proportions. The randomization process is generated by the Department of Biostatistics, Hospices Civils de Lyon, Lyon, France.
Main inclusion criteria are: elevated ALT, detectable HCV RNA, Metavir score over or equal to A1F1 and below or equal to F3. Patients received PEG-IFN 1.5µg/kg/week, ribavirin 800-1200mg/day and amantadine 200mg/day or placebo during 48 weeks.
The primary endpoint is a sustained virological response, defined as an undetectable HCV-RNA 24 weeks after treatment discontinuation (week 72). Secondary endpoints are the biochemical response at week 72 defined as ALT normalization; histological benefit; tolerance; and virological and biochemical responses during therapy at weeks 12, 24 and 48.
- Conditions
- Hepatitis C, Chronic
- Being tested
- peg-interferon alfa-2b, ribavirin, amantadine
- Keywords
- Hepatitis C, Chronic, peginterferon alfa-2b, ribavirin, Amantadine
- 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.
peg-interferon alfa-2bDrug
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 24 weeks after treatment discontinuation at week 72
Secondary outcomes (4)
Biochemical response at week 72 defined as ALT normalization
Histological benefit
Tolerance
Virological and biochemical responses during therapy at weeks 12, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2005 (estimated)
- Study startOct 2000
- Study completionMay 2003
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 405 participants
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Collaborators
- Schering-Plough
- Investigators
- Christian Trepo, MD, Principal investigator, Hépato-Gastroentérologie Hopital Hôtel-Dieu LYONP. ADELEINE, MD, Study chair, Laboratoire d'Informatique Médicale Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00122629
- Sponsor's protocol ID
- ANRSHC03 BITRI
- Status last verified
- Jul 2005
- First submitted
- 20 Jul 2005
- Last updated
- 29 Jul 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous HCV Non Responders ANRSHC03 BITRI
- ClinicalTrials.gov ID
- NCT00122629
- Acronym / sponsor ID
- ANRSHC03 BITRI
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis C, Chronic, peginterferon alfa-2b, ribavirin, Amantadine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 405 participants
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Collaborators
- Schering-Plough
- Study start
- Oct 2000
- Study completion
- May 2003
- First posted
- 22 Jul 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.
Triple antiviral therapy with peg-interferon-alfa/ribavirin+amantadine was suggested to increase sustained virological response (SVR) rates in HCV non-responders to a standard interferon/ribavirin combination.
Patients with hepatitis C virus infection were eligible if they had failed to respond to a single previous 24 week cycle of interferon/ribavirin combination therapy. Non-response was defined as persistent HCV RNA in the serum during the last month of treatment.
This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and amantadine or a placebo for 48 weeks.
Detailed description
Triple antiviral therapy with peg-interferon-alfa/ribavirin + amantadine was suggested to increase sustained virological response (SVR) rates in HCV non-responders to a standard interferon/ribavirin combination.
The aim of this study is to determine if the addition of amantadine to PEG-IFN/ribavirin enhances SVR.
This study is a double blind, comparative, prospective multicenter, randomized study. Patients are recruited from 23 hepatology centers in France. The protocol was approved by the French ethical committee and all patients provided written informed consent. Eligible subjects are randomly assigned to the two treatment groups in equal proportions. The randomization process is generated by the Department of Biostatistics, Hospices Civils de Lyon, Lyon, France.
Main inclusion criteria are: elevated ALT, detectable HCV RNA, Metavir score over or equal to A1F1 and below or equal to F3. Patients received PEG-IFN 1.5µg/kg/week, ribavirin 800-1200mg/day and amantadine 200mg/day or placebo during 48 weeks.
The primary endpoint is a sustained virological response, defined as an undetectable HCV-RNA 24 weeks after treatment discontinuation (week 72). Secondary endpoints are the biochemical response at week 72 defined as ALT normalization; histological benefit; tolerance; and virological and biochemical responses during therapy at weeks 12, 24 and 48.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Positive anti-HCV antibody test
- Patients who did not respond to treatment with standard interferon + ribavirin (HCV RNA+ by PCR in the last month of treatment)
- Compensated liver disease
- Neutrophil count over or equal to1000/mm3
- Platelet count over or equal to 100 giga/L
Key exclusion criteria (8 listed)
- Co-infection with hepatitis B or human immunodeficiency virus
- Any other cause of liver disease
- Active drug abuse, active alcohol consumption above 40g/day
- Organ grafts
- Presence of hepatocellular carcinoma
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 alfa-2b | Drug | – |
| ribavirin | Drug | – |
| amantadine | Drug | – |
Primary outcome
Sustained virological response, defined as an undetectable HCV-RNA 24 weeks after treatment discontinuation at week 72
4 secondary outcomes
Biochemical response at week 72 defined as ALT normalization
Histological benefit
Tolerance
Virological and biochemical responses during therapy at weeks 12, 24 and 48
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2005.
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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.
Christian Trepo, MD principal investigator
Hépato-Gastroentérologie Hopital Hôtel-Dieu LYON
P. ADELEINE, MD study chair
Laboratoire d'Informatique Médicale Lyon
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 peg-interferon alfa-2b, ribavirin and amantadine in people with Hepatitis C, Chronic, 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 8 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: stopped early, as of the sponsor's last update on 29 Jul 2005. 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 was stopped early. Results are not available in the source record.
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 24 weeks after treatment discontinuation at week 72. 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 29 Jul 2005.