Hepatitis CPhase 2NCT00535847
A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy
A Phase 2 study testing Telaprevir, Ribavirin and Pegylated interferon alfa 2a in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 62 sites in 8 countries.
Trial summary
To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. 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, Ribavirin and Pegylated interferon alfa 2a
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 62 sitesin 8 countries
- Study dates
- Oct 2007to Feb 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)
Who cannot join
None listed.
Trial locations and contacts
62 sites in 8 countries.
62 sites in 8 countries
United States39 sites
University of New Mexico
Albuquerque, New Mexico
Study site
Annandale, Virginia
Atlanta Gastroenterology Associates
Atlanta, Georgia
Johns Hopkins University
Baltimore, Maryland
Digestive and Liver Disease Clinic
Baton Rouge, Louisiana
Study site
Birmingham, Alabama
Beth Israel Deaconess Medical Center
Boston, Massachusetts
University of Virginia Health Systems
Charlottesville, Virginia
University of Chicago
Chicago, Illinois
University of Cincinnati
Cincinnati, Ohio
Study site
Cleveland, Ohio
Columbia Gastroenterology Associates, PA
Columbia, South Carolina
Liver Institute at Methodist Dallas
Dallas, Texas
University of Colorado Health Sciences Center
Denver, Colorado
Henry Ford Hospital
Detroit, Michigan
Duke University Medical Center
Durham, North Carolina
South Denver Gastroenterology
Englewood, Colorado
Metropolitan Research
Fairfax, Virginia
University of Florida
Gainesville, Florida
Memphis Gastroenterology Group
Germantown, Tennessee
Penn State Hershey Medical Center
Hershey, Pennsylvania
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Borland-Groover Clinic
Jacksonville, Florida
Mayo Clinic Jacksonville
Jacksonville, Florida
Study site
Los Angeles, California
North Shore University Hospital
Manhasset, New York
University of Miami Center for Liver Diseases
Miami, Florida
Study site
New York, New York
The Nebraska Medical Center
Omaha, Nebraska
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania
Virology Treatment Center, Maine Medical Center
Portland, Maine
McGuire DVAMC
Richmond, Virginia
Alamo Medical Research
San Antonio, Texas
Kaiser Permanente Internal Medicine
San Diego, California
Study site
San Francisco, California
Study site
Sarasota, Florida
St Louis University
St Louis, Missouri
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts
France6 sites
Hospital Henri Mondor
Créteil
Study site
Lyon
Study site
Nice
Study site
Paris
Study site
Pessac
Study site
Vandœuvre-lès-Nancy
Germany6 sites
Study site
Berlin
Universitatsklinikum Bonn
Bonn
University of Cologne
Cologne
Uniklinik Duesseldorf
Düsseldorf, 40225
Study site
Frankfurt
Study site
Hanover
Canada5 sites
University of Calgary Medical Clinic
Calgary, Alberta
University of Alberta
Edmonton, Alberta
Study site
Toronto, Ontario
University of British Columbia Vancouver General Hospital
Vancouver, British Columbia
Study site
Winnipeg, Manitoba
Netherlands3 sites
Academic Medical Center
Amsterdam
Leiden University Medical Center
Leiden
Erasmus MC Medical Center
Rotterdam
About this study
Official title: A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response
To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.
- Conditions
- Hepatitis C
- Being tested
- Telaprevir, Ribavirin, Pegylated interferon alfa 2a
- Keywords
- Genotype 1
- 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
Also called VX-950
Tablet
RibavirinDrug
Tablet
Pegylated interferon alfa 2aDrug
Solution for Injection
| Study group | Role | What they receive |
|---|---|---|
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week | Experimental | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks. Receives: Drug: Telaprevir; Drug: Ribavirin; Drug: Pegylated interferon alfa 2a |
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week | Experimental | Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Receives: Drug: Telaprevir; Drug: Ribavirin; Drug: Pegylated interferon alfa 2a |
| Other | Experimental | Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group. Receives: Drug: Telaprevir; Drug: Ribavirin; Drug: Pegylated interferon alfa 2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Measured: 24 weeks after the completion of treatment (up to Week 72)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
Measured: Baseline through Week 48
Secondary outcomes (4)
Percentage of Prior Relapsers With Undetectable HCV RNA
Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Measured: 24 weeks after the completion of treatment (up to Week 72)
Percentage of Subjects With End of Treatment Response
Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Measured: End of treatment (up to Week 48)
Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Measured: 48 weeks after completion of treatment (up to Week 96)
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response
Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.
Measured: Baseline up to Week 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Tibotec, Inc
- Responsible party
- Sponsor
- Investigators
- Nathalie Adda, MD, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535847
- Sponsor's protocol ID
- VX06-950-107
- Status last verified
- Jul 2014
- First submitted
- 25 Sep 2007
- Last updated
- 5 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response
- ClinicalTrials.gov ID
- NCT00535847
- Acronym / sponsor ID
- VX06-950-107
- Conditions
- Hepatitis C
- Keywords
- Genotype 1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- Tibotec, Inc
- Study start
- Oct 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Posted 25 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week | Experimental | Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated interferon alfa 2aTelaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks. |
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week | Experimental | Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated interferon alfa 2aTelaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. |
| Other | Experimental | Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated interferon alfa 2aSubjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in "Other" reporting group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TelaprevirAlso: VX-950Tablet | Drug | Other, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week |
| RibavirinTablet | Drug | Other, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week |
| Pegylated interferon alfa 2aSolution for Injection | Drug | Other, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week |
Primary outcome
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment
Time frame: 24 weeks after the completion of treatment (up to Week 72)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline through Week 48
AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.
4 secondary outcomes
Percentage of Prior Relapsers With Undetectable HCV RNA
Time frame: 24 weeks after the completion of treatment (up to Week 72)
Percentage of Subjects With End of Treatment Response
Time frame: End of treatment (up to Week 48)
Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment
Time frame: 48 weeks after completion of treatment (up to Week 96)
Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response
Time frame: Baseline up to Week 72
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nathalie Adda, MD study director
Vertex Pharmaceuticals Incorporated
62 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telaprevir, Ribavirin and Pegylated interferon alfa 2a in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 62 sites in 8 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 1 inclusion and 0 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 5 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 62 sites in United States, France, Germany, Canada, Netherlands and 3 more countries. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment (time frame: 24 weeks after the completion of treatment (up to Week 72)). 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 5 Aug 2014.