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
NCT ID: NCT01080222
Last Updated: 2020-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
152 participants
INTERVENTIONAL
2010-08-31
2013-11-30
Brief Summary
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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.
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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Treatment Arm A
Treatment 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.
telaprevir
tablet, 1125-mg, twice daily
VX-222
capsule, 100-mg, twice daily
Treatment Arm B
Treatment Arm B was discontinued as a result of patients meeting a pre-defined stopping rule relating to viral breakthrough.
telaprevir
tablet, 1125-mg, twice daily
VX-222
capsule, 400-mg, twice daily
Treatment Arm C
* 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.
telaprevir
tablet, 1125-mg, twice daily
VX-222
capsule, 100-mg, twice daily
ribavirin
tablet, 1000-mg for subjects weighing \<75-kg or 1200-mg for subjects weighing ≥75-kg, twice daily
peginterferon-alfa-2a
subcutaneous injection, 180-mcg, once weekly
Treatment Arm D
* 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.
telaprevir
tablet, 1125-mg, twice daily
ribavirin
tablet, 1000-mg for subjects weighing \<75-kg or 1200-mg for subjects weighing ≥75-kg, twice daily
peginterferon-alfa-2a
subcutaneous injection, 180-mcg, once weekly
VX-222
capsule, 400-mg, twice daily
Treatment Arm E
* 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.
telaprevir
tablet, 1125-mg, twice daily
ribavirin
tablet, 1000-mg for subjects weighing \<75-kg or 1200-mg for subjects weighing ≥75-kg, twice daily
VX-222
capsule, 400-mg, twice daily
Treatment Arm F
* 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.
telaprevir
tablet, 1125-mg, twice daily
ribavirin
tablet, 1000-mg for subjects weighing \<75-kg or 1200-mg for subjects weighing ≥75-kg, twice daily
VX-222
capsule, 400-mg, twice daily
Interventions
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telaprevir
tablet, 1125-mg, twice daily
VX-222
capsule, 100-mg, twice daily
ribavirin
tablet, 1000-mg for subjects weighing \<75-kg or 1200-mg for subjects weighing ≥75-kg, twice daily
peginterferon-alfa-2a
subcutaneous injection, 180-mcg, once weekly
VX-222
capsule, 400-mg, twice daily
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Vertex Pharmaceuticals Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Monitor
Role: STUDY_DIRECTOR
Vertex Pharmaceuticals Incorporated
Locations
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La Jolla, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Gainesville, Florida, United States
Atlanta, Georgia, United States
Marietta, Georgia, United States
Lutherville, Maryland, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
Egg Harbor, New Jersey, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Providence, Rhode Island, United States
Germantown, Tennessee, United States
Arlington, Texas, United States
San Antonio, Texas, United States
Falls Church, Virginia, United States
Auckland, , New Zealand
Christchurch, , New Zealand
Countries
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References
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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.
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.
Other Identifiers
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VX09-222-103
Identifier Type: -
Identifier Source: org_study_id
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