A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Did Not Respond to Therapy

Hepatitis C Clinical Trial

Official title:

A Phase 2 Rollover Protocol of Telaprevir (VX-950) in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Subjects Enrolled in the Control Group (Group A) of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Who Did Not Achieve or Maintain an Undetectable HCV RNA Level Through Sustained Viral Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535847
• Other study ID #: VX06-950-107
• Status: Completed
• Phase: Phase 2
• First received: September 25, 2007
• Last updated: July 9, 2014
• Start date: October 2007
• Est. completion date: February 2010

Study information

• Verified date: July 2014
• Source: Vertex Pharmaceuticals Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaGermany: Federal Institute for Drugs and Medical DevicesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479), and VX05-950-104EU (NCT00372385) who stopped treatment due to inadequate response to treatment. Safety, tolerability, and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels will be collected.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Enrolled in the control arm of Study VX06-950-106 (NCT00420784), VX05-950-104 (NCT00336479) or VX05-950-104EU (NCT00372385)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• Telaprevir
Tablet
• Ribavirin
Tablet
• Pegylated interferon alfa 2a
Solution for Injection

Locations

Country	Name	City	State
Canada	University of Calgary Medical Clinic	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	University of British Columbia Vancouver General Hospital	Vancouver	British Columbia
France	Hospital Henri Mondor	Creteil
Germany	Universitatsklinikum Bonn	Bonn
Germany	University of Cologne	Cologne
Germany	Uniklinik Duesseldorf	Dusseldorf
Netherlands	Academic Medical Center	Amsterdam
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Erasmus MC Medical Center	Rotterdam
Puerto Rico	Fundacion de Investigation de Diego	Santurce
United States	University of New Mexico	Albuquerque	New Mexico
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Johns Hopkins University	Baltimore	Maryland
United States	Digestive and Liver Disease Clinic	Baton Rouge	Louisiana
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	University of Virginia Health Systems	Charlottesville	Virginia
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Columbia Gastroenterology Associates, PA	Columbia	South Carolina
United States	Liver Institute at Methodist Dallas	Dallas	Texas
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	South Denver Gastroenterology	Englewood	Colorado
United States	Metropolitan Research	Fairfax	Virginia
United States	University of Florida	Gainesville	Florida
United States	Memphis Gastroenterology Group	Germantown	Tennessee
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	North Shore University Hospital	Manhasset	New York
United States	University of Miami Center for Liver Diseases	Miami	Florida
United States	The Nebraska Medical Center	Omaha	Nebraska
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Virology Treatment Center, Maine Medical Center	Portland	Maine
United States	McGuire DVAMC	Richmond	Virginia
United States	Alamo Medical Research	San Antonio	Texas
United States	Kaiser Permanente Internal Medicine	San Diego	California
United States	St Louis University	St Louis	Missouri
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Vertex Pharmaceuticals Incorporated	Tibotec, Inc

Countries where clinical trial is conducted

United States,  Austria,  Canada,  France,  Germany,  Netherlands,  Puerto Rico,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Treatment	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).	24 weeks after the completion of treatment (up to Week 72)	No
Primary	Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)	AE: any adverse change from the subject's baseline (pre-treatment) condition, including any adverse experience, abnormal recording or clinical laboratory assessment value which occurs during the course of the study, whether it is considered related to the study drug or not. An adverse event includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug. SAE: medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. "Study drug" includes all investigational agents (including placebo, if applicable) administered during the course of the study.	Baseline through Week 48	Yes
Secondary	Percentage of Prior Relapsers With Undetectable HCV RNA	Prior relapsers: subjects who had undetectable HCV RNA at the end of treatment in parent study but reverted to detectable levels of HCV RNA after stopping treatment in parent study were categorized as prior relapsers. Percentage of prior relapsers with undetectable HCV RNA 24 weeks after the completion of treatment in this study were presented. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).	24 weeks after the completion of treatment (up to Week 72)	No
Secondary	Percentage of Subjects With End of Treatment Response	Subjects were considered to have an end of treatment response if they completed the assigned treatment regimen and had undetectable HCV RNA at end of treatment or prematurely discontinued the assigned treatment regimen and had undetectable HCV RNA at the time of discontinuation. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).	End of treatment (up to Week 48)	No
Secondary	Percentage of Subjects With Undetectable HCV RNA at Week 48 After Completion of Treatment Among Subjects Who Completed Assigned Treatment	The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of detection was 10 international units per milliliter (IU/mL).	48 weeks after completion of treatment (up to Week 96)	No
Secondary	Cross Tabulation of Extended Rapid Viral Response (eRVR) and Sustained Viral Response (SVR) in With Prior Response	Cross tabulation of number of subjects with eRVR/SVR status in present study was presented with respect to prior response status of subjects in parent studies. eRVR=undetectable HCV RNA at Week 4 and Week 12, SVR=undetectable HCV RNA at end of treatment (EOT) and at 24 weeks after last dose of study treatment without any confirmed detectable HCV RNA in between. Prior response=subjects were categorized into following categories based on their viral response in the parent study: Null Response (less than [<] 1-log10 decrease in HCV RNA at Week 4 or <2-log10 decrease in HCV RNA at Week 12), Partial Response (greater than [>] 2-log10 decrease in HCV RNA at Week 12, but detectable HCV RNA at Week 24), Viral Breakthrough (detectable HCV RNA during treatment after achieving undetectable HCV RNA), Relapse (undetectable HCV RNA at EOT but detectable HCV RNA during viral follow-up). Plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay; lower limit of detection=10 IU/mL.	Baseline up to Week 72	No