Hepatitis CNCT00916474
Virology Follow up Study in Subjects Previously Treated With Telaprevir
An observational study of Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 41 sites in 5 countries.
Trial summary
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- telaprevir
- How many people
- 408 participants
- Where
- 41 sitesin 5 countries
- Study dates
- Jun 2009to Dec 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who have previously received at least 1 dose of telaprevir-based treatment (telaprevir plus peginterferon alfa 2a [Peg IFN-alfa-2a] with or without ribavirin [RBV]) in 1 of the following clinical studies: VX05-950-104, VX05 950-104EU, VX06-950-106, VX06-950-107, VX07-950-108, VX08-950-111, and VX-950-TiDP24-C216.
Who may be able to join
- Received at least 1 dose of telaprevir-based treatment in 1 of the following clinical studies: VX05-950-104, VX05-950-104EU, VX06-950-106, VX06-950-107, VX07-950-108, VX08-950-111, or VX-950-TiDP24-C216
- Have baseline HCV viral sequencing data available from previous telaprevir study
Who cannot join
- May not be currently participating in the antiviral follow-up period of an ongoing telaprevir trial. (Note: Subjects who have completed the required antiviral follow-up period but are still participating in the collection of patient-reported outcomes data for their previous telaprevir study may be eligible.)
- For subjects participating in ongoing studies at the time of enrollment, have more than 90 elapsed days between the database lock or unblinding in the previous telaprevir study and Day 1 in this study
Trial locations and contacts
41 sites in 5 countries.
41 sites in 5 countries
United States25 sites
New Mexico
Albuquerque, New Mexico
Georgia
Altanta, Georgia
Maryland
Baltimore, Maryland
Alabama
Birmingham, Alabama
Massachusetts
Boston, Massachusetts
North Carolina
Chapel Hill, North Carolina
Ohio
Cincinnati, Ohio
South Carolina
Columbia, South Carolina
California
Coronado, California
Colorado
Denver, Colorado
North Carolina
Durham, North Carolina
Colorado
Englewood, Colorado
Virginia
Fairfax, Virginia
Virginia
Falls Church, Virginia
Florida
Gainsville, Florida
Texas
Houston, Texas
Florida
Jacksonville, Florida
California
Los Angeles, California
New York
Manhasset, New York
Florida
Miami, Florida
New York
New York, New York
Michigan
Novi, Michigan
Texas
San Antonio, Texas
California
San Francisco, California
Missouri
St Louis, Missouri
Germany8 sites
Germany
Berlin
Germany
Cologne
Germany
Frankfurt
Germany
Freiburg im Breisgau
Germany
Hamburg
Germany
Hanover
Germany
Munich
Germany
Wien
France5 sites
France
Clichy
France
Marseille
France
Paris
France
Pessac
France
Vandœuvre-lès-Nancy
About this study
Official title: EXTEND: A 3-Year, Virology Follow up Study in Subjects Previously Treated With Telaprevir in Select Clinical Studies
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.
- Conditions
- Hepatitis C
- Being tested
- telaprevir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
telaprevirDrug
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time Receives: Drug: telaprevir | |
| Cohort B | Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time Receives: Drug: telaprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment
Measured: 3 years
Change in HCV variants with decreased sensitivity to telaprevir over time in subjects failing to achieve an SVR following telaprevir-based treatment
Measured: 3 years
Secondary outcomes (1)
Change in HCV variants with decreased sensitivity to telaprevir over time in subjects with late relapse
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2013
- Study completionDec 2013
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 Vertex Pharmaceuticals IncorporatedThe 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
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tibotec Pharmaceutical Limited
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916474
- Sponsor's protocol ID
- VX08-950-112
- Status last verified
- Feb 2014
- First submitted
- 4 Jun 2009
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXTEND: A 3-Year, Virology Follow up Study in Subjects Previously Treated With Telaprevir in Select Clinical Studies
- ClinicalTrials.gov ID
- NCT00916474
- Acronym / sponsor ID
- VX08-950-112
- Conditions
- Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Tibotec Pharmaceutical Limited
- Study start
- Jun 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 9 Jun 2009 (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.
Observational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | – | Drug: telaprevirObservational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time |
| Cohort B | – | Drug: telaprevirObservational follow-up study to assess long-term response to telaprevir and to evaluate changes in Hepatitis C virus over time |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have previously received at least 1 dose of telaprevir-based treatment (telaprevir plus peginterferon alfa 2a [Peg IFN-alfa-2a] with or without ribavirin [RBV]) in 1 of the following clinical studies: VX05-950-104, VX05 950-104EU, VX06-950-106, VX06-950-107, VX07-950-108, VX08-950-111, and VX-950-TiDP24-C216.
Key inclusion criteria (2 listed)
- Received at least 1 dose of telaprevir-based treatment in 1 of the following clinical studies: VX05-950-104, VX05-950-104EU, VX06-950-106, VX06-950-107, VX07-950-108, VX08-950-111, or VX-950-TiDP24-C216
- Have baseline HCV viral sequencing data available from previous telaprevir study
Key exclusion criteria (2 listed)
- May not be currently participating in the antiviral follow-up period of an ongoing telaprevir trial. (Note: Subjects who have completed the required antiviral follow-up period but are still participating in the collection of patient-reported outcomes data for their previous telaprevir study may be eligible.)
- For subjects participating in ongoing studies at the time of enrollment, have more than 90 elapsed days between the database lock or unblinding in the previous telaprevir study and Day 1 in this study
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 |
|---|---|---|
| telaprevir | Drug | Cohort A, Cohort B |
Primary outcome
Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment
Time frame: 3 years
Change in HCV variants with decreased sensitivity to telaprevir over time in subjects failing to achieve an SVR following telaprevir-based treatment
Time frame: 3 years
1 secondary outcome
Change in HCV variants with decreased sensitivity to telaprevir over time in subjects with late relapse
Time frame: 3 years
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 27 Feb 2014.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
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
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.
Medical Monitor study director
Vertex Pharmaceuticals Incorporated
41 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 41 sites in 5 countries.
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 2 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 27 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Germany, France, Canada, Puerto Rico. 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?
Proportion of subjects who maintain undetectable HCV RNA over time after achieving an SVR following telaprevir-based treatment (time frame: 3 years). The study lists 2 primary outcomes in all. 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 27 Feb 2014.