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Chronic Hepatitis C Virus InfectionPhase 2NCT01080222

A Safety and Efficacy Study of the Combination of VX-222 and Telaprevir in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Virus Infection

A Phase 2 study testing telaprevir, VX-222 and ribavirin in people with Chronic Hepatitis C Virus Infection, run by Vertex Pharmaceuticals Incorporated at 21 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis C Virus Infection
What is being tested?
telaprevir, VX-222 and ribavirin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
152 participants
Where
21 sitesin 2 countries
Study dates
Aug 2010to Nov 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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females of non-childbearing potential
  • Genotype 1 chronic hepatitis C
  • Laboratory evidence of HCV infection for 6 months
  • Histologic evidence of chronic hepatitis C
  • Subjects who have a body mass index (BMI) of ≤35 kg/m² (BMI = weight in kg / height² in meters)
  • Treatment Arm E: This arm will enroll only subjects infected with HCV genotype 1b virus
  • Treatment Arm F: This arm will enroll only subjects infected with HCV genotype 1a virus

Who cannot join

  • Subjects who have received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
  • Subjects with any contraindications to peginterferon alfa-2a and/or ribavirin
  • Subjects with 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 (NASH), or primary biliary cirrhosis
  • Histologic evidence of hepatic cirrhosis

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United States19 sites

  • Study site

    Arlington, Texas

  • Study site

    Atlanta, Georgia

  • Study site

    Aurora, Colorado

  • Study site

    Chapel Hill, North Carolina

  • Study site

    Cincinnati, Ohio

  • Study site

    Durham, North Carolina

  • Study site

    Egg Harbor, New Jersey

  • Study site

    Falls Church, Virginia

  • Study site

    Gainesville, Florida

  • Study site

    Germantown, Tennessee

  • Study site

    La Jolla, California

  • Study site

    Lutherville, Maryland

  • Study site

    Marietta, Georgia

  • Study site

    New York, New York

  • Study site

    Providence, Rhode Island

  • Study site

    Rochester, Minnesota

  • Study site

    San Antonio, Texas

  • Study site

    San Francisco, California

  • Study site

    St Louis, Missouri

Other trials in United States

New Zealand2 sites

  • Study site

    Auckland

  • Study site

    Christchurch

Other trials in New Zealand

About this study

Official title: A Randomized, Parallel-Group, Dose-Ranging Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Antiviral Activity of VX-222 and Telaprevir in Combination With and Without Peginterferon-Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C

The purpose of this study is to assess the safety and efficacy of combination treatment with VX-222 and telaprevir administered for 12 weeks with and without peginterferon-alfa-2a and/or ribavirin. The subjects enrolled in this study are chronically infected with hepatitis C virus (HCV) genotype 1 and will not have previously received treatment for their HCV infection.

This study will include an Investigational Phase and Extension Phase. These phases will contain a Treatment Period and a Follow-up Period. All subjects will be enrolled in the Investigational Phase of this study. Subjects who fail treatment during the Investigational Phase will have the option to enter the Extension Phase at which point they will be eligible to receive peginterferon alfa-2a and ribavirin for a total of 48 weeks.

Read more

Based on an evaluation of on-treatment safety, pharmacokinetic and antiviral data from patients in each arm of the trial, Vertex may elect to enroll up to two additional treatment arms (Treatment Arm E and Treatment Arm F) that will evaluate telaprevir/VX-222-based combination therapy. The components of the treatment regimens of these arms will be selected based on clinical data that emerges from the four initially-studied regimens. If enacted, up to 25 patients are expected to enroll in each additional treatment arm.

If Treatment Arm E or Treatment Arm F is discontinued subjects meeting certain criteria will have the option to enter a telaprevir-containing Rollover Phase. Subjects who do not meet the eligibility criteria to enter the Rollover Phase may elect to enter the Extension Phase.

Being tested
telaprevir, VX-222, ribavirin, peginterferon-alfa-2a
Keywords
VX-950

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • telaprevirDrug

    tablet, 1125-mg, twice daily

  • VX-222Drug

    capsule, 100-mg, twice daily

  • ribavirinDrug

    tablet, 1000-mg for subjects weighing <75-kg or 1200-mg for subjects weighing ≥75-kg, twice daily

  • peginterferon-alfa-2aBiological

    subcutaneous injection, 180-mcg, once weekly

  • VX-222Drug

    capsule, 400-mg, twice daily

Study groups in NCT01080222
Study groupRoleWhat they receive
Treatment Arm AExperimentalTreatment Arm A was discontinued as a result of patients meeting a pre-defined stopping rule related to viral breakthrough during the first four weeks of dosing.
Receives: Drug: telaprevir; Drug: VX-222
Treatment Arm BExperimentalTreatment Arm B was discontinued as a result of patients meeting a pre-defined stopping rule relating to viral breakthrough.
Receives: Drug: telaprevir; Drug: VX-222
Treatment Arm CExperimental* Subjects who meet pre-specified viral response criteria will stop their assigned treatment at 12 weeks. * Subjects who do not meet the pre-specified viral response criteria will receive peginterferon alfa-2a and ribavirin for an additional 12 weeks for a total treatment duration of 24 weeks. * Enrollment for this arm is complete. No additional subjects will be recruited.
Receives: Drug: telaprevir; Drug: VX-222; Drug: ribavirin; Biological: peginterferon-alfa-2a
Treatment Arm DExperimental* Subjects who meet pre-specified viral response criteria will stop their assigned treatment at 12 weeks. * Subjects who do not meet the pre-specified viral response criteria will receive peginterferon alfa-2a and ribavirin for an additional 12 weeks for a total treatment duration of 24 weeks. * Enrollment for this arm is complete. No additional subjects will be recruited.
Receives: Drug: telaprevir; Drug: ribavirin; Biological: peginterferon-alfa-2a; Drug: VX-222
Treatment Arm EExperimental* Subjects who meet pre-specified viral response criteria will stop their assigned treatment at 12 weeks. * Subjects who do not meet the pre-specified viral response criteria will receive peginterferon alfa-2a and ribavirin for an additional 24 weeks for a total treatment duration of 36 weeks.
Receives: Drug: telaprevir; Drug: ribavirin; Drug: VX-222
Treatment Arm FExperimental* Subjects who meet pre-specified viral response criteria will stop their assigned treatment at 12 weeks. * Subjects who do not meet the pre-specified viral response criteria will receive peginterferon alfa-2a and ribavirin for an additional 24 weeks for a total treatment duration of 36 weeks.
Receives: Drug: telaprevir; Drug: ribavirin; Drug: VX-222

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability

    Assessed by adverse events, physical examinations, vital signs, 12 lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis) vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (clinical chemistry, hematology, and urinalysis)

    Measured: 40 weeks

Secondary outcomes (4)

  1. Proportion of Subjects Who Achieve a Sustained Viral Response

    Measured: 24 weeks after the completion of the last dose of the assigned study drug treatment regimen

  2. Undetectable HCV RNA Measurements

    • Time to undetectability
    • Proportion of subjects who achieve undetectable HCV RNA levels at Week 2, Week 4, Week 8, and Week 12
    • Proportion of subjects who achieve undetectable HCV RNA levels at Week 2 and Week 8
    • Proportion of subjects who have undetectable HCV RNA levels at the end of treatment

    Measured: 36 weeks

  3. Proportion of Subjects Who Have a Viral Breakthrough or Relapse

    Measured: 60 weeks

  4. Plasma Exposures of VX-222 and Telaprevir

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionOct 2013
  4. Study completionNov 2013

Why it stopped: Study discontinued

Resources

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
152 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01080222
Sponsor's protocol ID
VX09-222-103
Status last verified
Sep 2020
First submitted
1 Mar 2010
Last updated
30 Sep 2020
Results posted
No
Data monitoring committee
No

Publications

  • Jiang M, Zhang EZ, Ardzinski A, Tigges A, Davis A, Sullivan JC, Nelson M, Spanks J, Dorrian J, Nicolas O, Bartels DJ, Rao BG, Rijnbrand R, Kieffer TL. Genotypic and phenotypic analyses of hepatitis C virus variants observed in clinical studies of VX-222, a nonnucleoside NS5B polymerase inhibitor. Antimicrob Agents Chemother. 2014 Sep;58(9):5456-65. doi: 10.1128/AAC.03052-14. Epub 2014 Jun 30.

    PubMed 24982088

  • Di Bisceglie AM, Sulkowski M, Gane E, Jacobson IM, Nelson D, DeSouza C, Alves K, George S, Kieffer T, Zhang EZ, Kauffman R, Asmal M, Koziel MJ. VX-222, a non-nucleoside NS5B polymerase inhibitor, in telaprevir-based regimens for genotype 1 hepatitis C virus infection. Eur J Gastroenterol Hepatol. 2014 Jul;26(7):761-73. doi: 10.1097/MEG.0000000000000084.

    PubMed 24901821

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing telaprevir, VX-222 and ribavirin in people with Chronic Hepatitis C Virus Infection, run by Vertex Pharmaceuticals Incorporated at 21 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 7 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: stopped early, as of the sponsor's last update on 30 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, New Zealand. 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 was stopped early (reason given: Study discontinued). Results are not available in the source record.

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?

Safety and Tolerability (time frame: 40 weeks). 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 NCT01080222, which also lists 2 linked publications.

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 30 Sep 2020.

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