Chronic Hepatitis CNCT00209755
Plasma Ribavirin Assay During Combination Therapy for Chronic Hepatitis C
A study testing therapeutic drug monitoring of ribavirin and dose adaptation in people with Chronic Hepatitis C, run by Hopital A Michallon at 1 site in France.
Trial summary
Investigation of the usefullness of therapeutical drug monitoring of ribavirin for dose adaptation during combination therapy of chronic hepatitis C patients. The correlation between ribavirin plasma concentration levels at week 4 (steady state) and early virological response (HCV-RNA decay from baseline to week 12)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- therapeutic drug monitoring of ribavirin and dose adaptation
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2003to Jul 2004
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with chronic hepatitis C related to genotype 1 or 4 virus and for which a combination therapy is needed will be eligible.
Who cannot join
- Patients with co-infection (either VHB or VIH) or with concomitant treatments expected to interact with the endpoints (hemoglobin, viral load, serum ribavirin) will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Value of Plasma Ribavirin Assay During the Combination Therapy " Pegylated Interferon + Ribavirin " in Chronic Hepatitis C.
Investigation of the usefullness of therapeutical drug monitoring of ribavirin for dose adaptation during combination therapy of chronic hepatitis C patients.
The correlation between ribavirin plasma concentration levels at week 4 (steady state) and early virological response (HCV-RNA decay from baseline to week 12) is to be tested in 40 patients approximately.
Read the detailed description
- Background and rational The serum concentrationS of ribavirin commonly range from 1 to 5 in patients during the combination treatment " interferon+ribavirin " (Larrat et al. 2003). However, the bioavailibility of ribavirin is not considered in the current recommendation for this treatment. The aim of this study is to demonstrate that the adaptation " à la carte " of ribavirin posology according to its serum concentration could improve the efficacy and the tolerance of the hepatitis C combination therapy.
- Study design This study is a prospective clinical pharmacology trial in patients on combination treatment for a chronic hepatitis C with genotype 1 or 4 virus. The evaluation will concern the serum ribavirin concentration during the first three months of treatment and its correlation with the evolution of hemoglobin (toxicity marker) or viral load (efficacy marker). After the 3 months of the study, a adaptation of posology based on serum ribavirin level will be offer to the patients for the rest of the treatment period. A control of the ribavirin level one month after the dose adaptation will be performed.
- Study treatments This trial is not a treatment evaluation. All the patients will receive the same treatment with PegInterferon alfa-2a and ribavirin according to the registered recommendations for use.
- Target population The study population will consist of patients with genotype 1 or 4 chronic hepatitis C and for which a combination therapy is indicated.
- Main selection criteria Patients with chronic hepatitis C related to genotype 1 or 4 virus and for which a combination therapy is needed will be eligible. Patients with co-infection (either VHB or VIH) or with concomitant treatments expected to interact with the endpoints (hemoglobin, viral load, serum ribavirin) will be excluded.
- Judgement endpoints There will be intermediate endpoints :
- blood hemoglobin concentration whom reduction during the 4 first weeks of treatment is a marker of toxicicty of the drug (induction of an hemolytic anemiae)
- viral load whom reduction of at least 2 log after 12 weeks of treatment is correlated with the sustained virologic response to treatment
- serum level of ribavirin for which it is expected a correlation with the two previous biological markers The primary judgement endpoint will be the statistical correlation as following :
- the serum concentration of ribavirine at the plateau of pharmacokinetics (J28(S4))
- the change of the hemoglobin concentration from D0 to D28(S4)
- the change of hemoglobin concentration between D0 and D84(S12)
- Secondary endpoints The thresholds of efficacy and toxicity of ribavirin will be determined by comparison of responder/non responder patients (as predicted by viral load change) and patients with/without toxicity. A correlation between the evolution of these two markers will be calculated.
- Conditions
- Chronic Hepatitis C
- Being tested
- therapeutic drug monitoring of ribavirin and dose adaptation
- Keywords
- chronic hepatitis C
- 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.
therapeutic drug monitoring of ribavirin and dose adaptationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
relationship between plasma ribavirin concentration and early virological response
Secondary outcomes (3)
safety
relationship between plasma ribavirin concentration and hemoglobin drop
dose effect of ribavirin on ribavirin plasma concentration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2003
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Hopital A Michallon
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Grenoble, Central Hospital, Nancy, France
- Investigators
- Jean Pierre ZARSKI, MD, Principal investigator, university hospital of Grenoble (France)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209755
- Sponsor's protocol ID
- ribatop - afssaps #031161
- Status last verified
- Sep 2004
- First submitted
- 13 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Plasma Ribavirin Assay During the Combination Therapy " Pegylated Interferon + Ribavirin " in Chronic Hepatitis C.
- ClinicalTrials.gov ID
- NCT00209755
- Acronym / sponsor ID
- ribatop - afssaps #031161
- Conditions
- Chronic Hepatitis C
- Keywords
- chronic hepatitis C
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 40 participants
- Lead sponsor
- Hopital A MichallonUniversity, hospital or other
- Collaborators
- University Hospital, Grenoble, Central Hospital, Nancy, France
- Study start
- Oct 2003
- Study completion
- Jul 2004
- First posted
- 21 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.
Investigation of the usefullness of therapeutical drug monitoring of ribavirin for dose adaptation during combination therapy of chronic hepatitis C patients.
The correlation between ribavirin plasma concentration levels at week 4 (steady state) and early virological response (HCV-RNA decay from baseline to week 12) is to be tested in 40 patients approximately.
Detailed description
- Background and rational The serum concentrationS of ribavirin commonly range from 1 to 5 in patients during the combination treatment " interferon+ribavirin " (Larrat et al. 2003). However, the bioavailibility of ribavirin is not considered in the current recommendation for this treatment. The aim of this study is to demonstrate that the adaptation " à la carte " of ribavirin posology according to its serum concentration could improve the efficacy and the tolerance of the hepatitis C combination therapy.
- Study design This study is a prospective clinical pharmacology trial in patients on combination treatment for a chronic hepatitis C with genotype 1 or 4 virus. The evaluation will concern the serum ribavirin concentration during the first three months of treatment and its correlation with the evolution of hemoglobin (toxicity marker) or viral load (efficacy marker). After the 3 months of the study, a adaptation of posology based on serum ribavirin level will be offer to the patients for the rest of the treatment period. A control of the ribavirin level one month after the dose adaptation will be performed.
- Study treatments This trial is not a treatment evaluation. All the patients will receive the same treatment with PegInterferon alfa-2a and ribavirin according to the registered recommendations for use.
- Target population The study population will consist of patients with genotype 1 or 4 chronic hepatitis C and for which a combination therapy is indicated.
- Main selection criteria Patients with chronic hepatitis C related to genotype 1 or 4 virus and for which a combination therapy is needed will be eligible. Patients with co-infection (either VHB or VIH) or with concomitant treatments expected to interact with the endpoints (hemoglobin, viral load, serum ribavirin) will be excluded.
- Judgement endpoints There will be intermediate endpoints :
- blood hemoglobin concentration whom reduction during the 4 first weeks of treatment is a marker of toxicicty of the drug (induction of an hemolytic anemiae)
- viral load whom reduction of at least 2 log after 12 weeks of treatment is correlated with the sustained virologic response to treatment
- serum level of ribavirin for which it is expected a correlation with the two previous biological markers The primary judgement endpoint will be the statistical correlation as following :
- the serum concentration of ribavirine at the plateau of pharmacokinetics (J28(S4))
- the change of the hemoglobin concentration from D0 to D28(S4)
- the change of hemoglobin concentration between D0 and D84(S12)
- Secondary endpoints The thresholds of efficacy and toxicity of ribavirin will be determined by comparison of responder/non responder patients (as predicted by viral load change) and patients with/without toxicity. A correlation between the evolution of these two markers will be calculated.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with chronic hepatitis C related to genotype 1 or 4 virus and for which a combination therapy is needed will be eligible.
Key exclusion criteria (1 listed)
- Patients with co-infection (either VHB or VIH) or with concomitant treatments expected to interact with the endpoints (hemoglobin, viral load, serum ribavirin) will be excluded.
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 |
|---|---|---|
| therapeutic drug monitoring of ribavirin and dose adaptation | Procedure or surgery | – |
Primary outcome
relationship between plasma ribavirin concentration and early virological response
3 secondary outcomes
safety
relationship between plasma ribavirin concentration and hemoglobin drop
dose effect of ribavirin on ribavirin plasma concentration
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 21 Sep 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.
Jean Pierre ZARSKI, MD principal investigator
university hospital of Grenoble (France)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic drug monitoring of ribavirin and dose adaptation in people with Chronic Hepatitis C, run by Hopital A Michallon 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 1 inclusion and 1 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 21 Sep 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.
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?
relationship between plasma ribavirin concentration and early virological response. 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 21 Sep 2005.