C Hepatitis, Tri TherapyRibatelaNCT01716403
Telaprevir Exposure and Severe Anemia in HCV Infected Patients Treated by Tri-therapy
An observational study of C Hepatitis, Tri Therapy, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The risk of severe anemia is increased in patients treated by tri-therapy compared to patients treated by bitherapy. The underlying mechanisms involved in this toxicity remain unexplored but could also depend on the global exposure of telaprevir. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C Hepatitis, Tri Therapy
- What is being tested?
- Diagnostic: protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2012to Oct 2014
- Phase
- Observational
- 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
Study population: 48 HCV-genotype 1 infected patients (16 naive patients, 16 prior partial responders/relapsers and 16 prior null responders to ribavirin/PEG-INF treatment)
Who may be able to join
- Man or woman older than 18 yr. 2- HCV genotype 1 infection as confirmed by a positive viral load 6 months after the selection visit or confirmed by the mean of a liver biopsy within 1 year before screening for the study.
- 3- Patient with one of the following criteria: Patient naive of any treatment against HCV infection Or Prior null responder patient: patient previously treated by ribavirin/PEG-INF for at least 12 weeks and whom HCV viral load decline was <2 log at week 12 Or Prior partial responder patient: patient previously treated by ribavirin/PEG-INF for at least 12 weeks, who never had a negative viral load while the viral load decline was >2 log at week 12 Or Prior relapser patient: patient previously treated by ribavirin/PEG-INF for 48 weeks, with a negative viral load at the end of treatment and a positive viral load 6 months later 4- Patient who has stopped his treatment for at least 12 weeks 5- Patient who had a liver biopsy or a Fibroscan within the 24 months before the start of the study with a Metavir fibrosis score F ≥ 3.
- 6- Patient who fulfills criteria for telaprevir treatment as defined by the licence 7- Patients who accepts to use 2 contraceptive methods until 6 months after the end of the treatment 8- Patient who had given his written informed consent 10- Patient insured under the french social security system
Who cannot join
- 1- Infection/co-infection by HCV genotype different than genotype 1 2- Patient with a medical contraindication to PEG-INF or ribavirin 3- Patient with history of allergy or intolerance to telaprevir 4- Patient using contraindicated drugs 5- Patient with history of decompensated liver disease and/or presenting biochemical measurements as follows at the inclusion visit:
- International Normalized Ratio (INR) > 1,5
- Albumin <3,3 g/dl
- Total bilirubin>1,8 N apart for patient with Gilbert syndrome 6- Liver disease from other causes 7- Patient with hepatocellular carcinoma or history of cancer 8- Patient with a history of graft transplantation and treated by immunosuppressive drugs 9- Patient who are regularly treated by corticosteroids 11- Patient with hemophilia or coagulation troubles 12- HIV or HBV co-infection 14- Patient with body mass index> 30 kg/m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Telaprevir Exposure on the Severe Anemia Induced by Ribavirin/Pegylated Interferon/Telaprevir Tri-therapy in HCV Infected Patients
The risk of severe anemia is increased in patients treated by tri-therapy compared to patients treated by bitherapy. The underlying mechanisms involved in this toxicity remain unexplored but could also depend on the global exposure of telaprevir. The trough concentration or AUC of telaprevir could therefore be a predictive factor of the onset of anemia in patients treated by ribavirin/PEG-INF/telaprevir. The early measurement of telaprevir and ribavirin concentrations could help to manage HCV tri-therapy to improve tolerance and SVR.
- Conditions
- C Hepatitis, Tri Therapy
- Being tested
- Diagnostic: protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition
- Keywords
- C hepatitis, telaprevir concentration, ribavirin oncentration, anemia
- Medical subject headings
- Hepatitis C, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic: protocol designed to evaluate one or more interventions aimed at identifying a disease or health conditionBiological
| Study group | Role | What they receive |
|---|---|---|
| HCV tritherapy and anemia | HCV-genotype 1 infected patients Receives: Biological: Diagnostic: protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
telaprevir concentration and area under the curve
Measured: Day 0, Day 2, week 2, week 4, week 8 and week12
Secondary outcomes (1)
ribavirin concentration and area under the curve
Measured: Day 0, Day 2, week 2, week 4, week 8 and week12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C Hepatitis, Tri TherapyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre Zarski, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01716403
- Sponsor's protocol ID
- 1211
- Acronym
- Ribatela
- Status last verified
- Jan 2017
- First submitted
- 25 Oct 2012
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Telaprevir Exposure on the Severe Anemia Induced by Ribavirin/Pegylated Interferon/Telaprevir Tri-therapy in HCV Infected Patients
- ClinicalTrials.gov ID
- NCT01716403
- Acronym / sponsor ID
- Ribatela / 1211
- Conditions
- C Hepatitis, Tri Therapy
- Keywords
- C hepatitis, telaprevir concentration, ribavirin oncentration, anemia
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2014 (actual)
- First posted
- 29 Oct 2012 (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 risk of severe anemia is increased in patients treated by tri-therapy compared to patients treated by bitherapy. The underlying mechanisms involved in this toxicity remain unexplored but could also depend on the global exposure of telaprevir. The trough concentration or AUC of telaprevir could therefore be a predictive factor of the onset of anemia in patients treated by ribavirin/PEG-INF/telaprevir. The early measurement of telaprevir and ribavirin concentrations could help to manage HCV tri-therapy to improve tolerance and SVR.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV tritherapy and anemia | – | Biological: Diagnostic: protocol designed to evaluate one or more interventions aimed at identifying a disease or health conditionHCV-genotype 1 infected patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 48 HCV-genotype 1 infected patients (16 naive patients, 16 prior partial responders/relapsers and 16 prior null responders to ribavirin/PEG-INF treatment)
Key inclusion criteria (3 listed)
- Man or woman older than 18 yr. 2- HCV genotype 1 infection as confirmed by a positive viral load 6 months after the selection visit or confirmed by the mean of a liver biopsy within 1 year before screening for the study.
- 3- Patient with one of the following criteria: Patient naive of any treatment against HCV infection Or Prior null responder patient: patient previously treated by ribavirin/PEG-INF for at least 12 weeks and whom HCV viral load decline was <2 log at week 12 Or Prior partial responder patient: patient previously treated by ribavirin/PEG-INF for at least 12 weeks, who never had a negative viral load while the viral load decline was >2 log at week 12 Or Prior relapser patient: patient previously treated by ribavirin/PEG-INF for 48 weeks, with a negative viral load at the end of treatment and a positive viral load 6 months later 4- Patient who has stopped his treatment for at least 12 weeks 5- Patient who had a liver biopsy or a Fibroscan within the 24 months before the start of the study with a Metavir fibrosis score F ≥ 3.
- 6- Patient who fulfills criteria for telaprevir treatment as defined by the licence 7- Patients who accepts to use 2 contraceptive methods until 6 months after the end of the treatment 8- Patient who had given his written informed consent 10- Patient insured under the french social security system
Key exclusion criteria (4 listed)
- 1- Infection/co-infection by HCV genotype different than genotype 1 2- Patient with a medical contraindication to PEG-INF or ribavirin 3- Patient with history of allergy or intolerance to telaprevir 4- Patient using contraindicated drugs 5- Patient with history of decompensated liver disease and/or presenting biochemical measurements as follows at the inclusion visit:
- International Normalized Ratio (INR) > 1,5
- Albumin <3,3 g/dl
- Total bilirubin>1,8 N apart for patient with Gilbert syndrome 6- Liver disease from other causes 7- Patient with hepatocellular carcinoma or history of cancer 8- Patient with a history of graft transplantation and treated by immunosuppressive drugs 9- Patient who are regularly treated by corticosteroids 11- Patient with hemophilia or coagulation troubles 12- HIV or HBV co-infection 14- Patient with body mass index> 30 kg/m2.
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 |
|---|---|---|
| Diagnostic: protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition | Biological | HCV tritherapy and anemia |
Primary outcome
telaprevir concentration and area under the curve
Time frame: Day 0, Day 2, week 2, week 4, week 8 and week12
1 secondary outcome
ribavirin concentration and area under the curve
Time frame: Day 0, Day 2, week 2, week 4, week 8 and week12
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 13 Jan 2017.
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, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of C Hepatitis, Tri Therapy, run by University Hospital, Grenoble 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: stopped early, as of the sponsor's last update on 13 Jan 2017. 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?
telaprevir concentration and area under the curve (time frame: Day 0, Day 2, week 2, week 4, week 8 and week12). 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 Jan 2017.