Hepatitis CNCT02881034
Ribavirin Bioavailability After Telaprevir Exposure
An observational study of Hepatitis C, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Triple therapy
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Feb 2015
- 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: Hepatitis C virus (HCV) infected patients with a previous non-response to pegylated-interferon/ribavirin therapy and re-treated with pegylated-interferon/ribavirin and telaprevir
Who may be able to join
- Patients with hepatitis C virus infection
- Previous non-response to pegylated-interferon/ribavirin therapy
- Re-treatment with pegylated-interferon/ribavirin and telaprevir
Who cannot join
- Decompensated liver cirrhosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ribavirin Bioavailability After Telaprevir Exposure in Hepatitis C Patients Treated With PEGylated -Interferon/Ribavirin/Telaprevir Triple Therapy
Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal function.
- Conditions
- Hepatitis C
- Being tested
- Triple therapy
- Keywords
- Anemia, Antiviral Agents, Glomerular Filtration Rate, Hepatitis C, Ribavirin, Telaprevir
- 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.
Triple therapyDrug
| Study group | Role | What they receive |
|---|---|---|
| Hepatitis C patients | Hepatitis C virus (HCV) infected patients with a previous non-response to pegylated-interferon/ribavirin therapy and re-treated with pegylated-interferon/ribavirin and telaprevir Receives: Drug: Triple therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ribavirin plasma trough concentration between baseline and week 4 of triple therapy
Plasma ribavirin trough concentrations were measured using a validated high-performance liquid chromatography-diode array detector method, a highly specific, sensible, and precise method of quantification
Measured: before telaprevir initiation during the previous course of PEG (pegylated)-IFN (interferon)/ribavirin combination therapy (T-1), and during the early phase (week 4 ± 2 weeks) of therapy
Secondary outcomes (5)
Change in renal function between baseline and week 4 of triple therapy
Renal function was assessed with the commonly used Modification of the Diet in Renal Disease (MDRD) study equation which allows to assess the estimated glomerular filtration rate (eGFR).
Measured: Before telaprevir initiation (T-1), and during the early phase (week 4 ± 2 weeks) of therapy
Ribavirin plasma trough concentration at week 8 of therapy
Measured: at the later phase of therapy (Week 8 ± 2 weeks)
Ribavirin plasma trough concentration after telaprevir withdrawal
Measured: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
Renal function at week 8 of therapy
Measured: at the later phase of therapy (Week 8 ± 2 weeks)
Renal function after telaprevir withdrawal
Measured: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startFeb 2014
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Retrospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881034
- Sponsor's protocol ID
- 69HCL16_0557
- Status last verified
- Aug 2016
- First submitted
- 18 Aug 2016
- Last updated
- 29 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ribavirin Bioavailability After Telaprevir Exposure in Hepatitis C Patients Treated With PEGylated -Interferon/Ribavirin/Telaprevir Triple Therapy
- ClinicalTrials.gov ID
- NCT02881034
- Acronym / sponsor ID
- 69HCL16_0557
- Conditions
- Hepatitis C
- Keywords
- Anemia, Antiviral Agents, Glomerular Filtration Rate, Hepatitis C, Ribavirin, Telaprevir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 26 Aug 2016 (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.
Anemia is more frequent in patients receiving telaprevir with pegylated-interferon/ribavirin than in those receiving pegylated-interferon/ribavirin alone. The objective was to measure the impact of telaprevir on ribavirin bioavailability and to assess the concomitant renal function.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hepatitis C patients | – | Drug: Triple therapyHepatitis C virus (HCV) infected patients with a previous non-response to pegylated-interferon/ribavirin therapy and re-treated with pegylated-interferon/ribavirin and telaprevir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hepatitis C virus (HCV) infected patients with a previous non-response to pegylated-interferon/ribavirin therapy and re-treated with pegylated-interferon/ribavirin and telaprevir
Key inclusion criteria (3 listed)
- Patients with hepatitis C virus infection
- Previous non-response to pegylated-interferon/ribavirin therapy
- Re-treatment with pegylated-interferon/ribavirin and telaprevir
Key exclusion criteria (1 listed)
- Decompensated liver cirrhosis
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 |
|---|---|---|
| Triple therapy | Drug | Hepatitis C patients |
Primary outcome
Change in ribavirin plasma trough concentration between baseline and week 4 of triple therapy
Time frame: before telaprevir initiation during the previous course of PEG (pegylated)-IFN (interferon)/ribavirin combination therapy (T-1), and during the early phase (week 4 ± 2 weeks) of therapy
Plasma ribavirin trough concentrations were measured using a validated high-performance liquid chromatography-diode array detector method, a highly specific, sensible, and precise method of quantification
5 secondary outcomes
Change in renal function between baseline and week 4 of triple therapy
Time frame: Before telaprevir initiation (T-1), and during the early phase (week 4 ± 2 weeks) of therapy
Ribavirin plasma trough concentration at week 8 of therapy
Time frame: at the later phase of therapy (Week 8 ± 2 weeks)
Ribavirin plasma trough concentration after telaprevir withdrawal
Time frame: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
Renal function at week 8 of therapy
Time frame: at the later phase of therapy (Week 8 ± 2 weeks)
Renal function after telaprevir withdrawal
Time frame: after telaprevir cessation (at least 4 weeks after telaprevir withdrawal (Week 16))
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 29 Aug 2016.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Not yet recruitingPhase 4
Combating Related Epidemics in HCV
HIV - Human Immunodeficiency Virus, Hepatitis B Virus (HBV)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Hepatitis C, run by Hospices Civils de Lyon 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 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: finished, as of the sponsor's last update on 29 Aug 2016. 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 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?
Change in ribavirin plasma trough concentration between baseline and week 4 of triple therapy (time frame: before telaprevir initiation during the previous course of PEG (pegylated)-IFN (interferon)/ribavirin combination therapy (T-1), and during the early phase (week 4 ± 2 weeks) of therapy). 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 Aug 2016.