HCV RecurrenceANRSCO23CUPILTNCT01944527
Use of Direct-acting Antiviral to Treat HCV Recurrence After Liver Transplantation (ANRSCO23CUPILT) Infection
An observational study of HCV Recurrence and Liver Transplantation, run by ANRS, Emerging Infectious Diseases at 1 site in France.
Trial summary
The purpose of this study is to evaluate the efficacy, safety and tolerability of direct-acting antivirals therapy in liver transplanted patients who experienced HCV recurrence. This cohort is multicentric with constitution of biobank (plasma, serum) and the prospective collect of biological and clinical data's in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCV Recurrence, Liver Transplantation, Direct-acting Antiviral Agents
- How many people
- 699 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Jun 2017
- 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: Liver transplant patients with recurrent hepatitis C virus infection treated with direct-acting antiviral agents and followed up in centers of transplantation of the university hospitals.
Who may be able to join
- Age > 18 years-old
- Liver transplanted patient
- Hepatitis C virus infection before transplantation
- HCV recurrence with a detectable HCV RNA before enrollment in cohort
- Use of at least one direct-acting antiviral agents with or without association with peginterferon and with or without association with ribavirin
- Treated by direct-acting antiviral agents or has been yet completed the treatment but still on follow up
- Affiliated to Health Insurance
- Written Signed consent form
Who cannot join
- Pregnant or breast-feeding female
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cohort of Liver Transplanted Patients With Hepatitis C Virus Recurrence and Treated With Direct-acting Antiviral Agents
The purpose of this study is to evaluate the efficacy, safety and tolerability of direct-acting antivirals therapy in liver transplanted patients who experienced HCV recurrence.
This cohort is multicentric with constitution of biobank (plasma, serum) and the prospective collect of biological and clinical data's in the liver transplanted patients with recurrent HCV infection and treated with direct-acting anti-HCV agents.
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of sustained virological response 12 weeks after discontinuation of direct-acting anti-HCV therapy in liver transplanted patients with HCV recurrence
Sustained virological response (SVR) at 12 weeks after the end of the treatment (SVR defined as undetectable HCV RNA measured by PCR en real time at 12 weeks after antiviral therapy discontinuation)
Measured: 12 weeks after discontinuation of therapy
Secondary outcomes (7)
Virological responses at 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation
Detectability of HCV RNA according to real time PCR
Measured: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation
Tolerability of direct acting antiviral HCV agents
Clinical and laboratory parameters (hepatic, renal, hematological in particular) to assess safety and recording of adverse events
Measured: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation
Drug-drug interactions
Trough blood concentration of immunosuppressive drugs
Measured: Baseline, 1,2,4,12,16, 24, 48 weeks during treatement and 4weeks after treatment discontinuation
To evaluate emergence of viral resistance to direct-acting antivirals agents
Measured: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation
To establish predictive factors of treatment failure and of emergence of viral resistance
The rate of anticipated antiviral treatment discontinuation because of intolerability or of severe adverse events
Measured: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation
Evaluate the incidence of graft loss and acute rejection
The rate of graft loss
Measured: Day 0, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation
Impact on concomitant therapy on virological responses and safety
Measured: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HCV RecurrenceStudies of the same condition, open and under way.
- More trials run by ANRS, Emerging Infectious DiseasesThe 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
- Enrolment
- 699 participants (actual)
Sponsor and investigators
- Lead sponsor
- ANRS, Emerging Infectious Diseases
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Georges Philippe Pageaux, Professsor, Principal investigator, HOSPITAL SAINT ELOI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944527
- Sponsor's protocol ID
- 2013-A00941-44
- Acronym
- ANRSCO23CUPILT
- Status last verified
- Feb 2016
- First submitted
- 13 Sep 2013
- Last updated
- 2 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barrail-Tran A, Goldwirt L, Gele T, Laforest C, Lavenu A, Danjou H, Radenne S, Leroy V, Houssel-Debry P, Duvoux C, Kamar N, De Ledinghen V, Canva V, Conti F, Durand F, D'Alteroche L, Botta-Fridlund D, Moreno C, Cagnot C, Samuel D, Fougerou-Leurent C, Pageaux GP, Duclos-Vallee JC, Taburet AM, Coilly A. Comparison of the effect of direct-acting antiviral with and without ribavirin on cyclosporine and tacrolimus clearance values: results from the ANRS CO23 CUPILT cohort. Eur J Clin Pharmacol. 2019 Nov;75(11):1555-1563. doi: 10.1007/s00228-019-02725-x. Epub 2019 Aug 5.
PubMed 31384986Antonini TM, Coilly A, Rossignol E, Fougerou-Leurent C, Dumortier J, Leroy V, Veislinger A, Radenne S, Botta-Fridlund D, Durand F, Houssel-Debry P, Kamar N, Canva V, Perre P, De Ledinghen V, Rohel A, Diallo A, Taburet AM, Samuel D, Pageaux GP, Duclos-Vallee JC; ANRS C023 CUPILT study group. Sofosbuvir-Based Regimens in HIV/HCV Coinfected Patients After Liver Transplantation: Results From the ANRS CO23 CUPILT Study. Transplantation. 2018 Jan;102(1):119-126. doi: 10.1097/TP.0000000000001928.
PubMed 28846559Leroy V, Dumortier J, Coilly A, Sebagh M, Fougerou-Leurent C, Radenne S, Botta D, Durand F, Silvain C, Lebray P, Houssel-Debry P, Kamar N, D'Alteroche L, Petrov-Sanchez V, Diallo A, Pageaux GP, Duclos-Vallee JC; Agence Nationale de Recherches sur le SIDA et les Hepatites Virales CO23 Compassionate Use of Protease Inhibitors in Viral C in Liver Transplantation Study Group. Efficacy of Sofosbuvir and Daclatasvir in Patients With Fibrosing Cholestatic Hepatitis C After Liver Transplantation. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1993-2001.e1-2. doi: 10.1016/j.cgh.2015.05.030. Epub 2015 Jun 1.
PubMed 26044317
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort of Liver Transplanted Patients With Hepatitis C Virus Recurrence and Treated With Direct-acting Antiviral Agents
- ClinicalTrials.gov ID
- NCT01944527
- Acronym / sponsor ID
- ANRSCO23CUPILT / 2013-A00941-44
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 699 participants (actual)
- Lead sponsor
- ANRS, Emerging Infectious DiseasesOther government
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 17 Sep 2013 (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 purpose of this study is to evaluate the efficacy, safety and tolerability of direct-acting antivirals therapy in liver transplanted patients who experienced HCV recurrence.
This cohort is multicentric with constitution of biobank (plasma, serum) and the prospective collect of biological and clinical data's in the liver transplanted patients with recurrent HCV infection and treated with direct-acting anti-HCV agents.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Liver transplant patients with recurrent hepatitis C virus infection treated with direct-acting antiviral agents and followed up in centers of transplantation of the university hospitals.
Key inclusion criteria (8 listed)
- Age > 18 years-old
- Liver transplanted patient
- Hepatitis C virus infection before transplantation
- HCV recurrence with a detectable HCV RNA before enrollment in cohort
- Use of at least one direct-acting antiviral agents with or without association with peginterferon and with or without association with ribavirin
Key exclusion criteria (1 listed)
- Pregnant or breast-feeding female
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The rate of sustained virological response 12 weeks after discontinuation of direct-acting anti-HCV therapy in liver transplanted patients with HCV recurrence
Time frame: 12 weeks after discontinuation of therapy
Sustained virological response (SVR) at 12 weeks after the end of the treatment (SVR defined as undetectable HCV RNA measured by PCR en real time at 12 weeks after antiviral therapy discontinuation)
7 secondary outcomes
Virological responses at 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation
Time frame: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation
Tolerability of direct acting antiviral HCV agents
Time frame: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation
Drug-drug interactions
Time frame: Baseline, 1,2,4,12,16, 24, 48 weeks during treatement and 4weeks after treatment discontinuation
To evaluate emergence of viral resistance to direct-acting antivirals agents
Time frame: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation
To establish predictive factors of treatment failure and of emergence of viral resistance
Time frame: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation
Evaluate the incidence of graft loss and acute rejection
Time frame: Day 0, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation
Impact on concomitant therapy on virological responses and safety
Time frame: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2016.
- Derived from this study: PubMed 31384986Barrail-Tran A, Goldwirt L, Gele T, Laforest C, Lavenu A, Danjou H, Radenne S, Leroy V, Houssel-Debry P, Duvoux C, Kamar N, De Ledinghen V, Canva V, Conti F, Durand F, D'Alteroche L, Botta-Fridlund D, Moreno C, Cagnot C, Samuel D, Fougerou-Leurent C, Pageaux GP, Duclos-Vallee JC, Taburet AM, Coilly A. Comparison of the effect of direct-acting antiviral with and without ribavirin on cyclosporine and tacrolimus clearance values: results from the ANRS CO23 CUPILT cohort. Eur J Clin Pharmacol. 2019 Nov;75(11):1555-1563. doi: 10.1007/s00228-019-02725-x. Epub 2019 Aug 5.
- Derived from this study: PubMed 28846559Antonini TM, Coilly A, Rossignol E, Fougerou-Leurent C, Dumortier J, Leroy V, Veislinger A, Radenne S, Botta-Fridlund D, Durand F, Houssel-Debry P, Kamar N, Canva V, Perre P, De Ledinghen V, Rohel A, Diallo A, Taburet AM, Samuel D, Pageaux GP, Duclos-Vallee JC; ANRS C023 CUPILT study group. Sofosbuvir-Based Regimens in HIV/HCV Coinfected Patients After Liver Transplantation: Results From the ANRS CO23 CUPILT Study. Transplantation. 2018 Jan;102(1):119-126. doi: 10.1097/TP.0000000000001928.
- Derived from this study: PubMed 26044317Leroy V, Dumortier J, Coilly A, Sebagh M, Fougerou-Leurent C, Radenne S, Botta D, Durand F, Silvain C, Lebray P, Houssel-Debry P, Kamar N, D'Alteroche L, Petrov-Sanchez V, Diallo A, Pageaux GP, Duclos-Vallee JC; Agence Nationale de Recherches sur le SIDA et les Hepatites Virales CO23 Compassionate Use of Protease Inhibitors in Viral C in Liver Transplantation Study Group. Efficacy of Sofosbuvir and Daclatasvir in Patients With Fibrosing Cholestatic Hepatitis C After Liver Transplantation. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1993-2001.e1-2. doi: 10.1016/j.cgh.2015.05.030. Epub 2015 Jun 1.
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.
Georges Philippe Pageaux, Professsor principal investigator
HOSPITAL SAINT ELOI
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 HCV Recurrence and Liver Transplantation, run by ANRS, Emerging Infectious Diseases 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 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: status not confirmed, as of the sponsor's last update on 2 Feb 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?
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?
The rate of sustained virological response 12 weeks after discontinuation of direct-acting anti-HCV therapy in liver transplanted patients with HCV recurrence (time frame: 12 weeks after discontinuation of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01944527, which also lists 3 linked publications.
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 2 Feb 2016.