Chronic Hepatitis CPhase 2NCT00336479
Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C
A Phase 2 study testing Telaprevir, Ribavirin and Pegylated Interferon Alfa 2a in people with Chronic Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 37 sites in 2 countries.
Trial summary
Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic 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?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 37 sitesin 2 countries
- Study dates
- Jun 2006to Feb 2008
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
- Have been infected with hepatitis C virus for greater than (>) 6 months
- Seronegative for hepatitis B surface antigen and Human Immunodeficiency Virus 1 and 2
- Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
- Female subjects must have a negative pregnancy test at all visits before the first dose
Who cannot join
- Received any approved or investigational drug or drug regimen for the treatment of hepatitis C
- Any medical contraindications to Pegylated Interferon Alfa 2a or Ribavirin therapy
- Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis or primary biliary cirrhosis
- Diagnosed or suspected hepatocellular carcinoma
- Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start
- Alcohol abuse or excessive use in the last 12 months
- Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study)
Trial locations and contacts
37 sites in 2 countries.
37 sites in 2 countries
United States36 sites
University of New Mexico
Albuquerque, New Mexico
Inova Fairfax Hospital
Annandale, Virginia, 22003
Call For Information
Baltimore, Maryland
Gulf Coast Research Associates
Baton Rouge, Louisiana
Beth Israel Deaconess Medical Center
Boston, Massachusetts
Call for Information
Boston, Massachusetts
Call For Information
Chapel Hill, North Carolina
University of Virginia Health System
Charlotteville, Virginia
University of Chicago Medical Center
Chicago, Illinois
University of Cincinnati College of Medicine
Cincinnati, Ohio
Baylor University Medical Center
Dallas, Texas
Methodist Hospital of Dallas
Dallas, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas
University of Colorado Hospital
Denver, Colorado
Henry Ford Health System
Detroit, Michigan
Call For Information
Durham, North Carolina
South Denver Gastroenterology
Englewood, Colorado
Metropolitan Research
Fairfax, Virginia, 22031
Shands Hospital University of Florida
Gainesville, Florida, 32610
Clarian Hospital
Indianapolis, Indiana, 46202
Cedars-Sinai Medical Center
Los Angeles, California
Call For Information
Manhasset, New York
Call for Information
Miami, Florida
Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin
Call for Information
New York, New York
Columbia University Medical Center
New York, New York
Stanford University Liver Research
Palo Alto, California
Fox Chase/ Temple Cancer Center
Philadelphia, Pennsylvania, 19140
University of Pennsylvania Hospital
Philadelphia, Pennsylvania
Call For Information
Phoenix, Arizona
McGuire VA Medical Center
Richmond, Virginia, 23249
Call For Information
Rochester, Minnesota
Alamo Medical Research
San Antonio, Texas, 78215
Call For Information
San Francisco, California
Saint Louis University
St Louis, Missouri
Call For Information
Worcester, Massachusetts
About this study
Official title: A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Received Prior Treatment
Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
- Conditions
- Chronic Hepatitis C
- Being tested
- Telaprevir, Ribavirin, Pegylated Interferon Alfa 2a, Placebo
- 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 VX-950
tablet
RibavirinDrug
Also called RBV
tablet
Pegylated Interferon Alfa 2aDrug
Also called Peg-IFN-alfa-2a
Solution for injection
PlaceboOther
matching placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week | Placebo comparator | Placebo (PBO) matched to telaprevir tablet orally 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 48 weeks. Receives: Drug: Ribavirin; Drug: Pegylated Interferon Alfa 2a; Other: Placebo |
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week | Experimental | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 |
| Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week | Experimental | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 24 weeks. Receives: Drug: Telaprevir; Drug: Ribavirin; Drug: Pegylated Interferon Alfa 2a |
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week | Experimental | Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. 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 Study Drug Dosing
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 study drug dosing (up to Week 72)
Secondary outcomes (4)
Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing
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: 12 weeks after the completion of study drug dosing (up to Week 60)
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 up to Week 48
Number of Subjects With Viral Relapse
Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. 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: After last dose of study drug up to antiviral follow-up (up to Week 72)
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.
Measured: Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionFeb 2008
- Study completionFeb 2008
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 263 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336479
- Sponsor's protocol ID
- VX05-950-104
- Status last verified
- Jun 2014
- First submitted
- 9 Jun 2006
- Last updated
- 23 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McHutchison JG, Everson GT, Gordon SC, Jacobson IM, Sulkowski M, Kauffman R, McNair L, Alam J, Muir AJ; PROVE1 Study Team. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med. 2009 Apr 30;360(18):1827-38. doi: 10.1056/NEJMoa0806104.
PubMed 19403902
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With Ribavirin (Copegus®) in Subjects With Genotype 1 Hepatitis C Who Have Not Received Prior Treatment
- ClinicalTrials.gov ID
- NCT00336479
- Acronym / sponsor ID
- VX05-950-104
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 13 Jun 2006 (estimated)
- Results
- Posted 21 Jul 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) and Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week | Placebo comparator | Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2a, Other: PlaceboPlacebo (PBO) matched to telaprevir tablet orally 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 48 weeks. |
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week | Experimental | Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2aSingle loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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. |
| Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week | Experimental | Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2aSingle loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 24 weeks. |
| Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week | Experimental | Drug: Telaprevir, Drug: Ribavirin, Drug: Pegylated Interferon Alfa 2aSingle loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir 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 weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
- Have been infected with hepatitis C virus for greater than (>) 6 months
- Seronegative for hepatitis B surface antigen and Human Immunodeficiency Virus 1 and 2
- Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
- Female subjects must have a negative pregnancy test at all visits before the first dose
Key exclusion criteria (7 listed)
- Received any approved or investigational drug or drug regimen for the treatment of hepatitis C
- Any medical contraindications to Pegylated Interferon Alfa 2a or Ribavirin therapy
- Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis or primary biliary cirrhosis
- Diagnosed or suspected hepatocellular carcinoma
- Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before study start
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 | Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week |
| RibavirinAlso: RBVtablet | Drug | PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week |
| Pegylated Interferon Alfa 2aAlso: Peg-IFN-alfa-2aSolution for injection | Drug | PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week, Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week, Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week |
| Placebomatching placebo tablet | Other | PBO 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 Study Drug Dosing
Time frame: 24 weeks after the completion of study drug dosing (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).
4 secondary outcomes
Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing
Time frame: 12 weeks after the completion of study drug dosing (up to Week 60)
Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to Week 48
Number of Subjects With Viral Relapse
Time frame: After last dose of study drug up to antiviral follow-up (up to Week 72)
Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
Time frame: Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 19403902McHutchison JG, Everson GT, Gordon SC, Jacobson IM, Sulkowski M, Kauffman R, McNair L, Alam J, Muir AJ; PROVE1 Study Team. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med. 2009 Apr 30;360(18):1827-38. doi: 10.1056/NEJMoa0806104.
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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.
Medical Monitor study director
Vertex Pharmaceuticals Incorporated
37 sites in 2 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 Chronic Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 37 sites in 2 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 5 inclusion and 7 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 23 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, 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. Some participants in this study may receive a placebo. 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 21 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 Study Drug Dosing (time frame: 24 weeks after the completion of study drug dosing (up to Week 72)). 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 NCT00336479, which also lists 1 linked publication.
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 23 Jul 2014.