Chronic Hepatitis CPhase 2NCT01726946
A Phase 2 Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
A Phase 2 study testing VX-135 and ribavirin in people with Chronic Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 6 sites in United States.
Trial summary
A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135 in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- VX-135 and ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 6 sitesUnited States
- Study dates
- Nov 2012to Feb 2014
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects (male and female) must be between the ages of 18 and 60 years at screening
- Subjects must have genotype 1 Chronic Hepatitis C
- Subjects must be treatment naïve
- Subjects must have laboratory values at screening within limits as specified by the protocol
Who cannot join
- Evidence of cirrhosis
- Female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study
- Any other cause of significant liver disease in addition to hepatitis C
- Human immunodeficiency virus -1 or -2
- Diagnosis of or suspected hepatocellular carcinoma
- History of organ transplant, with the exception of corneal transplants and skin grafts
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Texas
Arlington, Texas
Tennessee
Germantown, Tennessee
Texas
Houston, Texas
California
La Jolla, California
Georgia
Marietta, Georgia
Florida
Orlando, Florida
About this study
Official title: A Phase 2, Multicenter, Dose-Ranging Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135 in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C
- Conditions
- Chronic Hepatitis C
- Being tested
- VX-135, ribavirin
- Keywords
- Chronic Hepatitis C, HCV, CHC
- 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-135Drug
12 weeks of VX-135
ribavirinDrug
12 weeks of ribavirin
| Study group | Role | What they receive |
|---|---|---|
| VX-135 High Dose with ribavirin | Experimental | 12 weeks of a high dose of VX-135 in combination with ribavirin Receives: Drug: VX-135; Drug: ribavirin |
| VX-135 Low Dose with ribavirin | Experimental | 12 weeks of a low dose of VX-135 in combination with ribavirin Receives: Drug: VX-135; Drug: ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments
Measured: Up to 52 weeks
Secondary outcomes (8)
The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)
Measured: 16 weeks
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
Measured: 24 weeks
The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)
Measured: 36 weeks
The proportion of subjects who have virologic relapse
Measured: Up to 52 weeks
Viral kinetics, as determined at different time points by the proportion of subjects who achieve: -Undetectable HCV RNA -<LLOQ HCV RNA
Measured: Up to 64 weeks
The proportion of subjects who have virologic breakthrough
as measured by on-treatment HCV RNA values
Measured: Up to 52 weeks
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
Measured: up to 28 weeks
The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment
Measured: Up to 60 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 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
- NCT01726946
- Sponsor's protocol ID
- VX12-135-101
- Status last verified
- Mar 2015
- First submitted
- 7 Nov 2012
- Last updated
- 16 Apr 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Dose-Ranging Study to Evaluate the Safety and Efficacy of VX-135 With Ribavirin in Treatment-Naïve Subjects With Chronic Hepatitis C
- ClinicalTrials.gov ID
- NCT01726946
- Acronym / sponsor ID
- VX12-135-101
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic Hepatitis C, HCV, CHC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 15 Nov 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.
A Phase 2 study to evaluate the safety and efficacy of two different once daily doses VX-135 in combination with ribavirin in treatment-naïve subjects with chronic hepatitis C
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VX-135 High Dose with ribavirin | Experimental | Drug: VX-135, Drug: ribavirin12 weeks of a high dose of VX-135 in combination with ribavirin |
| VX-135 Low Dose with ribavirin | Experimental | Drug: VX-135, Drug: ribavirin12 weeks of a low dose of VX-135 in combination with ribavirin |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subjects (male and female) must be between the ages of 18 and 60 years at screening
- Subjects must have genotype 1 Chronic Hepatitis C
- Subjects must be treatment naïve
- Subjects must have laboratory values at screening within limits as specified by the protocol
Key exclusion criteria (6 listed)
- Evidence of cirrhosis
- Female subjects who are pregnant or nursing or male subjects with a female partner of childbearing potential who is unwilling to adhere to the contraception requirements, is pregnant or nursing, or planning to become pregnant during the study
- Any other cause of significant liver disease in addition to hepatitis C
- Human immunodeficiency virus -1 or -2
- Diagnosis of 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 |
|---|---|---|
| VX-13512 weeks of VX-135 | Drug | VX-135 High Dose with ribavirin, VX-135 Low Dose with ribavirin |
| ribavirin12 weeks of ribavirin | Drug | VX-135 High Dose with ribavirin, VX-135 Low Dose with ribavirin |
Primary outcome
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments
Time frame: Up to 52 weeks
8 secondary outcomes
The proportion of subjects who have an SVR at 4 weeks after the last planned dose of treatment (SVR4)
Time frame: 16 weeks
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
Time frame: 24 weeks
The proportion of subjects who have an SVR at 24 weeks after the last planned dose of treatment (SVR24)
Time frame: 36 weeks
The proportion of subjects who have virologic relapse
Time frame: Up to 52 weeks
Viral kinetics, as determined at different time points by the proportion of subjects who achieve: -Undetectable HCV RNA -<LLOQ HCV RNA
Time frame: Up to 64 weeks
The proportion of subjects who have virologic breakthrough
Time frame: Up to 52 weeks
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
Time frame: up to 28 weeks
The amino acid sequence of the nonstructural (NS)5B protein in subjects who fail treatment
Time frame: Up to 60 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 16 Apr 2015.
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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
6 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-135 and ribavirin in people with Chronic Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 6 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 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: finished, as of the sponsor's last update on 16 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms, echocardiograms (Cohorts 1 and 2 only), and laboratory assessments (time frame: Up to 52 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 16 Apr 2015.