VX-950-TiDP24-C219: A Roll Over Trial for Patients in the Control Group of the C216 Study Who Received Telaprevir Placebo

May 6, 2013 updated by: Janssen Infectious Diseases BVBA

An Open-label, Single-arm, Roll-over Trial of Telaprevir in Combination With Pegylated Interferon Alfa-2a (Pegasys) and Ribavirin (Copegus) for Subjects From the Control Group of the VX- 950-TiDP24-C216 Trial Who Failed Therapy for Virologic Reasons

The purpose of this study is to provide access to telaprevir for patients from the control group in the C216 study, who failed treatment for virologic reasons. Efficacy, safety and tolerability of telaprevir in combination with standard treatment will be evaluated.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is an open-label (i.e all people involved know the identity of the intervention), single-arm, roll-over trial of telaprevir in combination with pegylated interferon (Peg-IFN) alfa-2a and ribavirin (RBV). The purpose of the trial is to provide access to telaprevir for patients who were randomized to the control group in the VX-950-TiDP24-C216 trial (referred to as C216 trial hereafter) and who failed therapy for virologic reasons. The efficacy, safety, and tolerability of telaprevir in combination with Peg IFN alfa 2a and RBV will be evaluated. In addition, amino acid changes from baseline in the HCV NS3 (i.e protein associated with the hepatitis C virus) protease domain will be evaluated. The trial will consist of a screening period of approximately 28 days, a 48-week treatment period, and a 24-week follow-up period. It is expected that approximately 120 patients could be eligible for enrollment. Since the C216 trial is blinded until all patients reach Week 72 (or have discontinued earlier), patients can only enter the current trial upon invitation. The investigator will receive an invitation sent by the unblinded independent virology monitor of the C216 trial for those patients of the C216 trial who were randomized to the control group and who failed therapy for virologic reasons. Next to this invitation, the patient will need to fulfill the inclusion and exclusion criteria of the current trial in order to be eligible to participate. The screening visit for the current trial can only occur after the patient completes all assessments in the C216 trial, including the Safety Follow-up Visit. Patients must not enter this trial later than 80 weeks after their first dose in the C216 trial. In the current trial, all patients will receive 12 weeks of telaprevir 750 mg every 8 hours (q8h) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly and 1,000 or 1,200 mg/day (weight based), respectively, followed by 36 weeks of Peg IFN alfa 2a and RBV at standard doses. Patients with hepatitis C virus RNA levels < 25 IU/mL undetectable at the end of treatment (Week 48 or having discontinued earlier) will be followed for 24 weeks after the last dose of study medication to assess sustained virologic response (SVR). Safety/tolerability assessments will be performed and adverse events (AEs), regardless of severity, will be collected continuously until the Safety Follow-up Visit, scheduled 4 weeks after the last dose of study medication. Thereafter, only serious adverse events (SAEs) will be reported. All patients will receive 12 weeks of telaprevir 750 mg q8h (orally) in combination with Peg-IFN alfa-2a and RBV at standard doses, i.e., 180 microgram once weekly (injection) and 1,000 or 1,200 mg/day (weight-based) (orally), respectively, followed by 36 weeks of Peg IFN alfa-2a and RBV at standard doses.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Adelaide, Australia
      • Clayton, Australia
      • Darlinghurst, Australia
      • Perth, Australia
  • Belgium
      • Brussels, Belgium
      • Gent, Belgium
      • Leuven, Belgium
  • Brazil
      • Distrito Barao Geraldo-Campina, Brazil
      • Salvador, Brazil
      • Sao Paulo, Brazil
  • Canada
    • Quebec
      • Montreal, Quebec, Canada
  • France
      • Clichy, France
      • Créteil, France
      • Lille Cedex, France
      • Pessac, France
  • Germany
      • Berlin, Germany
      • Frankfurt, Germany
      • Hamburg, Germany
      • Hannover, Germany
      • Köln, Germany
      • München, Germany
  • Israel
      • Petah Tiqva, Israel
      • Zefat, Israel
  • Netherlands
      • Amsterdam, Netherlands
      • Nijmegen, Netherlands
  • Poland
      • Bialystok, Poland
      • Czeladz, Poland
      • Warszawa, Poland
  • Puerto Rico
      • San Juan, Puerto Rico
  • Spain
      • Barcelona, Spain
      • Valencia, Spain
  • Sweden
      • Stockholm, Sweden
  • Switzerland
      • Zurich N/A, Switzerland
  • United Kingdom
      • London, United Kingdom
  • United States
    • California
      • Coronado, California, United States
      • Los Angeles, California, United States
      • San Francisco, California, United States
    • Florida
      • Bradenton, Florida, United States
      • Miami, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Missouri
      • Kansas City, Missouri, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Columbia, South Carolina, United States
    • Texas
      • Houston, Texas, United States
      • San Antonio, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient from the control group of the C216 study who failed therapy for virologic reasons
  • Patient must have completed all assessments in the C216 trial
  • Patient must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication

Exclusion Criteria:

  • Patient received any direct acting anti-viral HCV therapy after discontinuation of the C216 trial
  • Patient has history of decompensated liver disease
  • Patient has history of acute or chronic pancreatitis
  • Patient has condition that requires use of systemic corticosteroids
  • Patient who prematurely stopped medication for non-compliance or for whom it would be unsafe to repeat treatment
  • Patient has history of decompensated liver disease or history of cirrhosis with hepatocellular carcinoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Telaprevir + Standard Treatment
Telaprevir 750 mg orally (by mouth) every 8h for 12 weeks plus standard treatment. Standard treatment is 180 mcg subcutaneous (under the skin) injection pegylated interferon (Peg-IFN) alfa-2a and 1000-1200 mg twice daily ribavirin (RBV) for 48 weeks.
Drug: Telaprevir
750 mg orally every 8 hours (q8h) for 12 weeks
Drug: pegylated interferon (Peg-IFN) alfa-2a
180 microgram (mcg) by subcutaneous injection once weekly for 48 weeks.
Drug: ribavirin (RBV)
1,000 or 1,200 mg/day (weight based) orally twice daily for 48 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Percentage of Participants Achieving a Sustained Virologic Response (SVR) 24 Weeks After the Last Dose of Study Drug (SVR24 Actual)
Time Frame: End of trial (24 weeks after last dose, administerd at 48 weeks)
The table below shows the percentage of participants acheiving a SVR 24 weeks after the last dose of study drug defined as having plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels < 25 IU/mL, target not detected at end of treatment (EOT) AND the participant did not relapse AND the participant completed the treatment; OR if the participant had plasma HCV RNA levels of < 25 IU/mL, target not detected at EOT AND the participant did not relapse AND the participant prematurely discontinued at least one study medication, but never for the reason virologic failure.
End of trial (24 weeks after last dose, administerd at 48 weeks)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Percentage of Participants Achieving Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values of Less Than 25 IU/ml, Target Not Detected at Different Time Points
Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)
The table below shows the percentage of participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels of less than 25 IU/ml, target not detected at different time points during the study. Data was imputed for participants with missing values using the last observation carried forward (LOCF) method for missing values.
Baseline, Weeks 4, 8, 12, 24, 36, and 48, and at the end of treatment (Week 48 or at time of early discontinuation)
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue Telaprevir and Continue Pegylated Interferon (Peg-IFN) and Ribavirin (RBV) at Week 4 or Week 8
Time Frame: Week 4, Week 8
The table below shows the percentage of participants at Week 4 or 8 who met a stopping rule defined as having a hepatitis C virus (HCV) ribonucleic acid (RNA) value >100 IU/mL.
Week 4, Week 8
Percentage of Participants Who Met a Virologic Stopping Rule That Required Them to Permanently Discontinue All Study Drugs at Week 12, 24, or 36
Time Frame: Week 12 or Weeks 24 or 36
The table below shows the percentage of participants at Week 12, 24, and 36 who met a stopping rule. The stopping rule at Week 12 was having hepatitis C virus (HCV) ribonucleic acid (RNA) value of >100 IU/mL and the stopping rule at Weeks 24 or 36 was having a HCV RNA value of >=25 IU/mL.
Week 12 or Weeks 24 or 36
Percentage of Participants Achieving Rapid Virologic Response (RVR)
Time Frame: Week 4
The table below shows the percentage of participants who had a rapid virologic response (RVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at Week 4 of treatment).
Week 4
Percentage of Participants Achieving Extended Rapid Virologic Response (eRVR)
Time Frame: Weeks 4 and 12
The table below shows the percentage of participants who had a Extended Rapid Virologic Response (eRVR) (ie, those with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA values of <25 IU/mL, target not detected at at Weeks 4 and 12 of treatment).
Weeks 4 and 12
Percentage of Participants With Viral Breakthrough
Time Frame: Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase)
The table below shows the percentage of participants with viral breakthrough defined as a confirmed increase >1 log10 in hepatitis C virus (HCV) ribonucleic acid (RNA) level from the lowest level reached during the considered treatment phase up to the considered time point, if the lowest level reached is > 25 IU/mL, or a confirmed value of HCV RNA >100 IU/mL in participants whose HCV RNA had previously become <25 IU/mL (detected or target not detected) during the considered treatment phase.
Week 48 (Period After Telaprevir Intake) and Week 12 (Telaprevir Treatment Phase)
Percentage of Participants Who Relapsed During Follow-Up
Time Frame: During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks)
The table below shows the percentage of participants who relapsed (ie, those having confirmed detectable hepatitis C virus [HCV] ribonucleic acid [RNA] during the 24-week follow-up period after previous HCV RNA <25 IU/mL, target not detected, at end of treatment).
During Follow-Up (24 weeks after the last dose of study drug, administerd at 48 weeks)
Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values Over Time
Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, 48
The table below shows plasma Hepatitis C virus (HCV) ribonucleic acid (RNA) values measured over time.
Baseline, Weeks 4, 8, 12, 24, 36, 48
Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level
Time Frame: Baseline, Weeks 4, 8, 12, 24, 36, and 48
The table below shows change from baseline in log 10 plasma HCV RNA values measured over time.
Baseline, Weeks 4, 8, 12, 24, 36, and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Infectious Diseases BVBA

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vertex Pharmaceuticals Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR016678
  • VX-TiDP24-C219 (Other Identifier: Janssen Infectious Diseases BVBA)
  • 2009-012613-21 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings