Chronic Hepatitis CGENUPINCT01577069
Predictive Factors of the Treatment Failure in Hepatitis C Virus (HCV) Infected Patients Treated With Telaprevir
An observational study of Chronic Hepatitis C, run by Association HGE CHU Bordeaux Sud at 1 site in France.
Trial summary
The purpose of the study is to 1- detect and quantify HCV-PI resistant mutants with ultra-deep pyrosequencing (UDPS) technology, 2 - detect SNPs in P-glyocoprotein and CYP3A genes, in HCV mono-infected patients under/after Telaprevir treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis C
- How many people
- 73 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2011to Jan 2013
- 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: HCV mono-infected patients treated in the Hepatology Unit of Pr Victor de Lédinghen (Hôpital du Haut-Lévêque, Pessac)
Who may be able to join
- HCV mono-infected subjects
- Age > 18 years
Who cannot join
- HBV co-infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Factors of the Treatment Failure in HCV Mono-infected Patients Treated With Pegylated-interferon/Ribavirin/Telaprevir.
The purpose of the study is to
1- detect and quantify HCV-PI resistant mutants with ultra-deep pyrosequencing (UDPS) technology, 2 - detect SNPs in P-glyocoprotein and CYP3A genes, in HCV mono-infected patients under/after Telaprevir treatment.
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Direct Antiviral agent (DAA), Ultra-deep pyrosequencing, Single polynucleotide polymorphisms, Treatment-resistant mutants, Hepatitis C Virus Protease Inhibitor
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What is being measured
The primary outcome is the main question the study is designed to answer.
virological resitance
Measured: 12 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2012 (estimated)
- Study startFeb 2011
- Primary completionJan 2013
- Study completionJan 2013
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 73 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association HGE CHU Bordeaux Sud
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux
- Responsible party
- Sponsor
- Investigators
- Victor de lédinghen, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577069
- Sponsor's protocol ID
- UDPS-100211
- Acronym
- GENUPI
- Status last verified
- Jun 2016
- First submitted
- 12 Apr 2012
- Last updated
- 22 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors of the Treatment Failure in HCV Mono-infected Patients Treated With Pegylated-interferon/Ribavirin/Telaprevir.
- ClinicalTrials.gov ID
- NCT01577069
- Acronym / sponsor ID
- GENUPI / UDPS-100211
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C, Direct Antiviral agent (DAA), Ultra-deep pyrosequencing, Single polynucleotide polymorphisms, Treatment-resistant mutants, Hepatitis C Virus Protease Inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (estimated)
- Lead sponsor
- Association HGE CHU Bordeaux SudUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux
- Study start
- Feb 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Apr 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 purpose of the study is to
1- detect and quantify HCV-PI resistant mutants with ultra-deep pyrosequencing (UDPS) technology, 2 - detect SNPs in P-glyocoprotein and CYP3A genes, in HCV mono-infected patients under/after Telaprevir treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HCV mono-infected patients treated in the Hepatology Unit of Pr Victor de Lédinghen (Hôpital du Haut-Lévêque, Pessac)
Key inclusion criteria (2 listed)
- HCV mono-infected subjects
- Age > 18 years
Key exclusion criteria (1 listed)
- HBV co-infection
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
virological resitance
Time frame: 12 weeks after treatment
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 22 Jun 2016.
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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.
Victor de lédinghen, MD, PhD principal investigator
University Hospital, Bordeaux
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 Chronic Hepatitis C, run by Association HGE CHU Bordeaux Sud 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 2 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 22 Jun 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?
virological resitance (time frame: 12 weeks after treatment). 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 22 Jun 2016.