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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01080222
Registration number
NCT01080222
Ethics application status
Date submitted
1/03/2010
Date registered
4/03/2010
Date last updated
30/09/2020
Titles & IDs
Public title
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
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Scientific 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
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Secondary ID [1]
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VX09-222-103
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C Virus Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - telaprevir
Treatment: Drugs - VX-222
Treatment: Drugs - ribavirin
Treatment: Other - peginterferon-alfa-2a
Treatment: Drugs - VX-222
Experimental: 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.
Experimental: Treatment Arm B - Treatment Arm B was discontinued as a result of patients meeting a pre-defined stopping rule relating to viral breakthrough.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Treatment: Drugs: telaprevir
tablet, 1125-mg, twice daily
Treatment: Drugs: VX-222
capsule, 100-mg, twice daily
Treatment: Drugs: ribavirin
tablet, 1000-mg for subjects weighing \<75-kg or 1200-mg for subjects weighing =75-kg, twice daily
Treatment: Other: peginterferon-alfa-2a
subcutaneous injection, 180-mcg, once weekly
Treatment: Drugs: VX-222
capsule, 400-mg, twice daily
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and Tolerability
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Assessment method [1]
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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)
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Timepoint [1]
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40 weeks
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Secondary outcome [1]
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Proportion of Subjects Who Achieve a Sustained Viral Response
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Assessment method [1]
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Timepoint [1]
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24 weeks after the completion of the last dose of the assigned study drug treatment regimen
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Secondary outcome [2]
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Undetectable HCV RNA Measurements
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Assessment method [2]
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* 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
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Timepoint [2]
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36 weeks
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Secondary outcome [3]
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Proportion of Subjects Who Have a Viral Breakthrough or Relapse
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Assessment method [3]
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Timepoint [3]
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60 weeks
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Secondary outcome [4]
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Plasma Exposures of VX-222 and Telaprevir
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Assessment method [4]
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Timepoint [4]
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12 weeks
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Eligibility
Key inclusion criteria
* 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
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/08/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2013
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Sample size
Target
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Accrual to date
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Final
152
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Maryland
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Minnesota
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Missouri
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New Jersey
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New York
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North Carolina
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Ohio
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Rhode Island
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Tennessee
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Texas
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Virginia
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New Zealand
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Auckland
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New Zealand
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Vertex Pharmaceuticals Incorporated
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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. 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. 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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Trial website
https://clinicaltrials.gov/study/NCT01080222
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Trial related presentations / 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. 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.
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Public notes
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Contacts
Principal investigator
Name
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Medical Monitor
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Address
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Vertex Pharmaceuticals Incorporated
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01080222
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