Hepatitis C, ChronicPhase 3CONCISENCT01459913
Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype
A Phase 3 study testing Telaprevir, Pegylated Interferon Alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Vertex Pharmaceuticals Incorporated at 83 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Telaprevir, Pegylated Interferon Alfa-2a and Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 83 sitesin 6 countries
- Study dates
- Nov 2011to Jan 2014
- Phase
- Phase 3
- 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
- Male and female subjects, 18 to 70 years of age, inclusive
- Treatment-naive OR subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (SVR24) after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a documented undetectable HCV RNA level at the planned end of treatment of at least 42-week duration
- Subjects have IL28B CC genotype determined during screening
- Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required
Who cannot join
- Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis C
- Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and never achieved undetectable HCV RNA while on treatment
- Subjects have evidence of hepatic decompensation
- Subjects have evidence of cirrhosis
- Subjects have diagnosed or suspected hepatocellular carcinoma
- Subjects have any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis. Steatosis is allowed if clinically asymptomatic
Trial locations and contacts
83 sites in 6 countries.
83 sites in 6 countries
United States55 sites
Study site
Arlington, Texas, 76012
Study site
Atlanta, Georgia, 30308
Study site
Baltimore, Maryland, 21202
Study site
Baltimore, Maryland, 21287
Study site
Birmingham, Alabama, 35209
Study site
Birmingham, Alabama, 35294
Study site
Boston, Massachusetts, 02215
Study site
Bradenton, Florida, 34209
Study site
Brockton, Massachusetts, 02302
Study site
Burlington, Massachusetts, 01805
Study site
Chapel Hill, North Carolina, 27599
Study site
Charlotte, North Carolina, 28203
Study site
Chicago, Illinois, 60611
Study site
Chicago, Illinois, 60612
Study site
Columbia, Maryland, 21045
Study site
Durham, North Carolina, 27710
Study site
Egg Harbor, New Jersey, 08234
Virginia
Fairfax, Virginia, 22031
Study site
Falls Church, Virginia, 22042
Study site
Farmington, Connecticut, 06030
Study site
Flushing, New York, 11355
Study site
Gainesville, Florida, 32224
Pennsylvania
Hershey, Pennsylvania, 17033
Study site
Honolulu, Hawaii, 96817
Study site
Houston, Texas, 77030
Study site
Jacksonville, Florida, 32224
Study site
Jacksonville, Florida, 32256
Study site
Kansas City, Missouri, 64131
Study site
La Jolla, California, 93037
Study site
Lebanon, New Hampshire, 03756
Study site
Los Angeles, California, 90027
California
Los Angeles, California, 90048
Study site
Madison, Wisconsin, 53715
Study site
Madison, Wisconsin, 53792
Study site
Manhasset, New York, 10030
Study site
Marietta, Georgia, 30060
Study site
Milwaukee, Wisconsin, 53226
Study site
New Haven, Connecticut, 06511
Study site
New York, New York, 10003
Study site
New York, New York, 10021
Study site
New York, New York, 10029
Study site
Norfolk, Virginia, 23502
Study site
Novi, Michigan, 48202
Study site
Orlando, Florida, 32803
Study site
Phoenix, Arizona, 85054
Study site
Richmond, Virginia, 23249
Study site
Sacramento, California, 95817
Study site
San Antonio, Texas, 78215
Study site
San Diego, California, 92103
Study site
San Diego, California, 92105
Study site
San Diego, California, 92154
California
San Francisco, California, 94115
Study site
Seattle, Washington, 98101
Study site
Vineland, New Jersey, 08360
Study site
Worcester, Massachusetts, 01605
Germany8 sites
Study site
Berlin, 10969
Study site
Cologne, 50937
Study site
Düsseldorf, 40237
Study site
Frankfurt, 60590
Study site
Hamburg, 20099
Study site
Hanover, 30625
Study site
Leipzig, 4103
Study site
Munich, 81377
Canada7 sites
Study site
Calgary, Alberta, T2N 4Z6
Study site
Edmonton, Alberta, T5M 1J7
Study site
Edmonton, Alberta, T6G 2X8
Study site
Toronto, Ontario, M5G 2N2
Study site
Toronto, Ontario, M5T 2S8
Study site
Vancouver, British Columbia, V6T 1Z3
Study site
Winnipeg, Manitoba, R3E 3P4
Israel6 sites
Study site
Haifa, 31096
Study site
Haifa, 34362
Israel
Jerusalem, 91120
Study site
Nazareth, 16100
Study site
Petah Tikva, 49100
Study site
Tel HaShomer, 52621
Poland4 sites
Study site
Bialystok, 16-540
Study site
Czeladź, 41-250
Study site
Mysłowice, 41-400
Study site
Wroclaw, 50-220
Austria3 sites
Study site
Linz, 4010
Study site
Vienna, 1090
Study site
Vienna, 1160
About this study
Official title: A Phase 3b Study of 2 Treatment Durations of Telaprevir, Peg-IFN (Pegasys®), and Ribavirin (Copegus®) in Treatment-Naive and Prior Relapser Subjects With Genotype 1 Chronic Hepatitis C and IL28B CC Genotype
The purpose of this study is to evaluate if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Telaprevir, Pegylated Interferon Alfa-2a, Ribavirin
- Keywords
- VX-950, INCIVEK, INCIVO
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TelaprevirDrug
Also called INCIVEK, INCIVO, VX-950
Tablet
Pegylated Interferon Alfa-2aDrug
Also called Pegasys, Peg-IFN-Alfa-2a
Subcutaneous Injection
RibavirinDrug
Also called Copegus, RBV
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Experimental | Telaprevir 1125 milligram (mg) tablet twice 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 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment. Receives: Drug: Telaprevir; Drug: Pegylated Interferon Alfa-2a; Drug: Ribavirin |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Experimental | Telaprevir 1125 mg tablet twice 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 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned. Receives: Drug: Telaprevir; Drug: Pegylated Interferon Alfa-2a; Drug: Ribavirin |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) | Experimental | Telaprevir 1125 mg tablet twice 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 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned. Receives: Drug: Telaprevir; Drug: Pegylated Interferon Alfa-2a; Drug: Ribavirin |
| Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) | Experimental | Telaprevir 1125 mg tablet twice 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. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned. Receives: Drug: Telaprevir; Drug: Pegylated Interferon Alfa-2a; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Measured: 12 weeks after last planned dose of study drug (up to Week 36)
Secondary outcomes (8)
Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
SVR4 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 4 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Measured: 4 weeks after last planned dose of study drug (up to Week 28)
Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
SVR24 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 24 weeks after last planned dose of study treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Measured: 24 weeks after last planned dose of study drug (up to Week 48)
Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)
SVR72 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Week 72. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Measured: Week 72
Percentage of Subjects With Viral Relapse
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up in subjects who had HCV RNA less than (<) lower limit of quantification (LLOQ) at end of treatment. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The LLOQ was 25 IU/mL and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Measured: After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up
Percentage of Subjects With On-Treatment Virologic Failure
On-treatment virologic failure was defined as subjects who met futility (as per investigator discretion) or who completed the assigned treatment duration and had detectable HCV RNA at planned end of treatment (up to 48 weeks). This outcome was planned to be assessed in all reporting groups and results were to be reported for total arm as well.
Measured: Baseline up to Week 48
Number of Subjects With Rapid Viral Response (RVR)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. RVR was defined as undetectable HCV RNA 4 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Measured: Week 4
Number of Subjects With Extended Rapid Viral Response (eRVR)
The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 IU/mL and the lower limit of detection was 10 IU/mL. eRVR was defined as undetectable HCV RNA at both 4 weeks and 12 weeks after the start of study treatment. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
Measured: Week 4 and Week 12
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 administered during the course of the study.
Measured: Baseline up to Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2011 (estimated)
- Study startNov 2011
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: The study was terminated early by the sponsor on 13 January 2014 due to a decision to modify the drug development plan.
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 C, ChronicStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark Friedman, M.D., Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01459913
- Sponsor's protocol ID
- VX11-950-114
- Acronym
- CONCISE
- Status last verified
- May 2015
- First submitted
- 24 Oct 2011
- Last updated
- 10 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3b Study of 2 Treatment Durations of Telaprevir, Peg-IFN (Pegasys®), and Ribavirin (Copegus®) in Treatment-Naive and Prior Relapser Subjects With Genotype 1 Chronic Hepatitis C and IL28B CC Genotype
- ClinicalTrials.gov ID
- NCT01459913
- Acronym / sponsor ID
- CONCISE / VX11-950-114
- Conditions
- Hepatitis C, Chronic
- Keywords
- VX-950, INCIVEK, INCIVO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early by the sponsor on 13 January 2014 due to a decision to modify the drug development plan.
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Oct 2011 (estimated)
- Results
- Posted 11 Feb 2015
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 if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized) | Experimental | Drug: Telaprevir, Drug: Pegylated Interferon Alfa-2a, Drug: RibavirinTelaprevir 1125 milligram (mg) tablet twice 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 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment. |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) | Experimental | Drug: Telaprevir, Drug: Pegylated Interferon Alfa-2a, Drug: RibavirinTelaprevir 1125 mg tablet twice 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 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned. |
| Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized) | Experimental | Drug: Telaprevir, Drug: Pegylated Interferon Alfa-2a, Drug: RibavirinTelaprevir 1125 mg tablet twice 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 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned. |
| Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized) | Experimental | Drug: Telaprevir, Drug: Pegylated Interferon Alfa-2a, Drug: RibavirinTelaprevir 1125 mg tablet twice 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. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female subjects, 18 to 70 years of age, inclusive
- Treatment-naive OR subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (SVR24) after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a documented undetectable HCV RNA level at the planned end of treatment of at least 42-week duration
- Subjects have IL28B CC genotype determined during screening
- Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required
Key exclusion criteria (6 listed)
- Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis C
- Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and never achieved undetectable HCV RNA while on treatment
- Subjects have evidence of hepatic decompensation
- Subjects have evidence of cirrhosis
- Subjects have diagnosed or suspected hepatocellular carcinoma
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: INCIVEK, INCIVO, VX-950Tablet | Drug | Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized), Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized), Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized), Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) |
| Pegylated Interferon Alfa-2aAlso: Pegasys, Peg-IFN-Alfa-2aSubcutaneous Injection | Drug | Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized), Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized), Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized), Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) |
| RibavirinAlso: Copegus, RBVTablet | Drug | Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized), Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized), Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized), Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized) |
Primary outcome
Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
Time frame: 12 weeks after last planned dose of study drug (up to Week 36)
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at 12 weeks after last planned dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL) and the lower limit of detection was 10 IU/mL. This outcome was planned to be assessed only in "Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)" and "Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)" reporting groups.
8 secondary outcomes
Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
Time frame: 4 weeks after last planned dose of study drug (up to Week 28)
Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
Time frame: 24 weeks after last planned dose of study drug (up to Week 48)
Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)
Time frame: Week 72
Percentage of Subjects With Viral Relapse
Time frame: After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up
Percentage of Subjects With On-Treatment Virologic Failure
Time frame: Baseline up to Week 48
Number of Subjects With Rapid Viral Response (RVR)
Time frame: Week 4
Number of Subjects With Extended Rapid Viral Response (eRVR)
Time frame: Week 4 and Week 12
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
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.
Mark Friedman, M.D. study director
Vertex Pharmaceuticals Incorporated
83 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Telaprevir, Pegylated Interferon Alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Vertex Pharmaceuticals Incorporated at 83 sites in 6 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 4 inclusion and 6 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: stopped early, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 83 sites in United States, Germany, Canada, Israel, Poland and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 11 Feb 2015). 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 Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12) (time frame: 12 weeks after last planned dose of study drug (up to Week 36)). 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 10 Jun 2015.