Chronic Hepatitis C VirusPhase 2NCT01581138
VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
A Phase 2 study testing VX-222, telaprevir and ribavirin in people with Chronic Hepatitis C Virus, run by Vertex Pharmaceuticals Incorporated at 18 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet. 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 18 sitesUnited States
- Study dates
- Jul 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 (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
- Subjects will be treatment naïve
- Subjects must have documentation of the presence or absence of cirrhosis
Who cannot join
- History or other clinical evidence of significant or unstable cardiac disease
- Evidence of hepatic decompensation
- Diagnosed or suspected hepatocellular carcinoma
- 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
- History of organ transplant, with the exception of corneal transplants and skin grafts
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Study site
Anaheim, California
Study site
Asheville, North Carolina
Study site
Austin, Texas
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Cincinnati, Ohio
Study site
Englewood, Colorado
Study site
Germantown, Tennessee
Study site
Marietta, Georgia
Study site
Nashville, Tennessee
Study site
New York, New York
Study site
Norfolk, Virginia
Study site
Orlando, Florida
Study site
Pittsburgh, Pennsylvania
Study site
Riverside, California
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Winston-Salem, North Carolina
About this study
Official title: A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a Chronic Hepatitis C
The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
- Conditions
- Chronic Hepatitis C Virus
- Being tested
- VX-222, telaprevir, ribavirin
- 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
400 mg tablets twice daily for oral administration
telaprevirDrug
Also called VX-950, INCIVEK, INCIVO, TELAVIC
1125 mg tablets twice daily for oral administration
ribavirinDrug
Also called Copegus
1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
| Study group | Role | What they receive |
|---|---|---|
| 12 week treatment | Experimental | Not described Receives: Drug: VX-222; Drug: telaprevir; Drug: ribavirin |
| 16 week treatment | Experimental | Not described Receives: Drug: VX-222; Drug: telaprevir; Drug: ribavirin |
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 viral response (SVR) at 12 weeks after the last planned dose of treatment
Measured: 12 weeks after the last planned dose of treatment
Secondary outcomes (9)
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)
Measured: up to 20 weeks
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug
Measured: 24 weeks after the last planned dose of the study drug
The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug
Measured: 4 weeks after the last planned dose of the study drug
The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT)
Measured: 48 weeks either after the last planned dose of study drug or after time of failure
The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT)
Measured: up to 16 weeks
Time to achieve <LLOQ undetectable HCV RNA
Measured: up to 16 weeks
The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have ≥LLOQ HCV RNA at the end of study drug treatment (EOT)
Measured: up to 16 weeks
The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12
Measured: 12 weeks after the last planned dose of treatment
The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure
Measured: 48 weeks either after the last planned dose of study drug or after time of failure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study startJul 2012
- Primary completionJun 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 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
- NCT01581138
- Sponsor's protocol ID
- VX11-222-108
- Status last verified
- Jul 2014
- First submitted
- 17 Apr 2012
- Last updated
- 4 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT01581138
- Acronym / sponsor ID
- VX11-222-108
- Conditions
- Chronic Hepatitis C Virus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 20 Apr 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 efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 week treatment | Experimental | Drug: VX-222, Drug: telaprevir, Drug: ribavirin |
| 16 week treatment | Experimental | Drug: VX-222, Drug: telaprevir, Drug: ribavirin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects must have genotype 1 chronic hepatitis C (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
- Subjects will be treatment naïve
- Subjects must have documentation of the presence or absence of cirrhosis
Key exclusion criteria (5 listed)
- History or other clinical evidence of significant or unstable cardiac disease
- Evidence of hepatic decompensation
- Diagnosed or suspected hepatocellular carcinoma
- 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
- History of organ transplant, with the exception of corneal transplants and skin grafts
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-222400 mg tablets twice daily for oral administration | Drug | 12 week treatment, 16 week treatment |
| telaprevirAlso: VX-950, INCIVEK, INCIVO, TELAVIC1125 mg tablets twice daily for oral administration | Drug | 12 week treatment, 16 week treatment |
| ribavirinAlso: Copegus1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily | Drug | 12 week treatment, 16 week treatment |
Primary outcome
The proportion of subjects who have a sustained viral response (SVR) at 12 weeks after the last planned dose of treatment
Time frame: 12 weeks after the last planned dose of treatment
9 secondary outcomes
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)
Time frame: up to 20 weeks
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug
Time frame: 24 weeks after the last planned dose of the study drug
The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug
Time frame: 4 weeks after the last planned dose of the study drug
The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT)
Time frame: 48 weeks either after the last planned dose of study drug or after time of failure
The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT)
Time frame: up to 16 weeks
Time to achieve <LLOQ undetectable HCV RNA
Time frame: up to 16 weeks
The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have ≥LLOQ HCV RNA at the end of study drug treatment (EOT)
Time frame: up to 16 weeks
The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12
Time frame: 12 weeks after the last planned dose of treatment
The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure
Time frame: 48 weeks either after the last planned dose of study drug or after time of failure
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 4 Jul 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
18 sites in 1 country: 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 18 sites in United States.
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 3 inclusion and 5 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 4 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 18 sites in United States. 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 viral response (SVR) at 12 weeks after the last planned dose of treatment (time frame: 12 weeks after the last planned dose of treatment). 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 4 Jul 2014.