Chronic Hepatitis C VirusPhase 2NCT01516918
A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis
A Phase 2 study testing VX-222, telaprevir and ribavirin in people with Chronic Hepatitis C Virus, run by Vertex Pharmaceuticals Incorporated at 43 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C Virus
- What is being tested?
- VX-222, telaprevir 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
- 103 participants
- Where
- 43 sitesin 5 countries
- Study dates
- Feb 2012to Dec 2013
- Phase
- Phase 2
- 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
Who may be able to join
- Subjects must have genotype 1 Chronic Hepatitis C
- Subjects must have compensated cirrhosis
- Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
- Subjects with hemophilia may be permitted to enroll with permission of the medical monitor
Who cannot join
- Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
- Any contraindication to Peg-IFN or RBV therapy
- Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
- A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines
Trial locations and contacts
43 sites in 5 countries.
43 sites in 5 countries
United States28 sites
Study site
Arlington, Texas
Study site
Asheville, North Carolina
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Bradenton, Florida
Study site
Charlotte, North Carolina
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Detroit, Michigan
Study site
Durham, North Carolina
Study site
Egg Harbor, New Jersey
Study site
Englewood, Colorado
Study site
Germantown, Tennessee
Study site
Houston, Texas
Study site
Indianapolis, Indiana
Study site
Jacksonville, Florida
Study site
Lebanon, New Hampshire
Study site
Madison, Wisconsin
Study site
Manhasset, New York
Study site
Marietta, Georgia
Study site
Milwaukee, Wisconsin
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Providence, Rhode Island
Study site
Rochester, New York
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Tampa, Florida
Germany6 sites
Study site
Cologne
Study site
Hamburg
Study site
Heidelberg
Study site
Hessen
Study site
Saschen
Study site
Stuttgart
Canada3 sites
Study site
London, Ontario
Study site
Montreal, Quebec
Study site
Vancouver, British Columbia
United Kingdom3 sites
Study site
London
Study site
Plymouth
Study site
Scotland
About this study
Official title: A Multicenter, Open-Label Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis
The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis.
- Conditions
- Chronic Hepatitis C Virus
- Being tested
- VX-222, telaprevir, ribavirin, peginterferon-alfa-2a
- 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.
VX-222Drug
tablet, 400-mg twice daily
telaprevirDrug
Also called Incivek, VX-950, Incivo
tablet, 1125-mg twice daily
ribavirinDrug
Also called Copegus
tablet, 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily
peginterferon-alfa-2aBiological
Also called Pegasys
subcutaneous injection, 180-mcg, once weekly
| Study group | Role | What they receive |
|---|---|---|
| Quadruple Regimen | Experimental | All subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks. Receives: Drug: VX-222; Drug: telaprevir; Drug: ribavirin; Biological: peginterferon-alfa-2a |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12)
Measured: 12 weeks
Secondary outcomes (7)
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments.
Measured: up to 48 weeks
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24)
Measured: 24 weeks
The proportion of subjects who achieve undetectable HCV RNA at Weeks 2, 4, 8, and 12 after the first dose of study drug, and at the end of planned study drug treatment
Measured: up to week 12
The proportion of subjects who have on-treatment virologic failure defined as subjects who either meet a futility rule or who complete the assigned treatment duration and have HCV RNA at the end of study drug treatment
Measured: up to 48 weeks
The association of the IL-28B genotype with SVR12
Proportion of subjects who have SVR12 by IL-28B genotype
Measured: 12 weeks
The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure
The identity and observed frequency of viral variants as compared to wild-type virus will be measured.
Measured: After the last planned dose of study drug or after time of failure
VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 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 Chronic Hepatitis C VirusStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 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
- NCT01516918
- Sponsor's protocol ID
- VX11-222-106
- Status last verified
- Oct 2014
- First submitted
- 13 Jan 2012
- Last updated
- 20 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis
- ClinicalTrials.gov ID
- NCT01516918
- Acronym / sponsor ID
- VX11-222-106
- Conditions
- Chronic Hepatitis C Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 25 Jan 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 this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quadruple Regimen | Experimental | Drug: VX-222, Drug: telaprevir, Drug: ribavirin, Biological: peginterferon-alfa-2aAll subjects will receive active study drugs (quadruple regimen: VX-222, telaprevir,Peg-IFN, and RBV) for a fixed treatment duration of 24 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must have genotype 1 Chronic Hepatitis C
- Subjects must have compensated cirrhosis
- Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
- Subjects with hemophilia may be permitted to enroll with permission of the medical monitor
Key exclusion criteria (4 listed)
- Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
- Any contraindication to Peg-IFN or RBV therapy
- Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
- A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines
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 |
|---|---|---|
| VX-222tablet, 400-mg twice daily | Drug | Quadruple Regimen |
| telaprevirAlso: Incivek, VX-950, Incivotablet, 1125-mg twice daily | Drug | Quadruple Regimen |
| ribavirinAlso: Copegustablet, 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily | Drug | Quadruple Regimen |
| peginterferon-alfa-2aAlso: Pegasyssubcutaneous injection, 180-mcg, once weekly | Biological | Quadruple Regimen |
Primary outcome
The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12)
Time frame: 12 weeks
7 secondary outcomes
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments.
Time frame: up to 48 weeks
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24)
Time frame: 24 weeks
The proportion of subjects who achieve undetectable HCV RNA at Weeks 2, 4, 8, and 12 after the first dose of study drug, and at the end of planned study drug treatment
Time frame: up to week 12
The proportion of subjects who have on-treatment virologic failure defined as subjects who either meet a futility rule or who complete the assigned treatment duration and have HCV RNA at the end of study drug treatment
Time frame: up to 48 weeks
The association of the IL-28B genotype with SVR12
Time frame: 12 weeks
The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure
Time frame: After the last planned dose of study drug or after time of failure
VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations
Time frame: 12 weeks
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 20 Oct 2014.
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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
43 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VX-222, telaprevir and ribavirin in people with Chronic Hepatitis C Virus, run by Vertex Pharmaceuticals Incorporated at 43 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 4 inclusion and 4 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 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Germany, Canada, Poland, United Kingdom. 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?
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?
The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12) (time frame: 12 weeks). 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 20 Oct 2014.