A Rollover Study for Subjects Participating in the Control Arm of Study VX06-950-106, VX05-950-104 and VX05-950-104EU Whose Plasma HCV RNA Levels Did Not Respond to Therapy - Full Text View

Purpose

To provide access to a telaprevir-based treatment to subjects of the Control Group of Study VX06-950-106, VX05-950-104, and VX05-950-104EU who stopped treatment due to inadequate response to treatment. Safety, tolerability, and HCV RNA levels will be collected.

Condition	Intervention	Phase
Hepatitis C	Drug: telaprevir Drug: ribavirin Drug: Peg-interferon Alfa-2a	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

Drug Information available for: Interferon Ribavirin Interferon Alfa-2a Peginterferon Alfa-2a Telaprevir

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:

Proportion of Subjects With Undetectable HCV RNA [ Time Frame: 24 weeks after the completion of treatment ] [ Designated as safety issue: No ]
Proportion of Subjects with SVR24 (undetectable HCV RNA 24 weeks after the completion of treatment)
Adverse Events and Clinical Laboratory Assessments [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Proportion of Subjects With Undetectable HCV RNA; Subset Analysis by Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse [ Time Frame: 24 weeks after the completion of treatment ] [ Designated as safety issue: No ]
Proportion of subjects with SVR24 (undetectable HCV RNA 24 weeks after the completion of treatment) in prior relapsers
Proportion of Subjects With Undetectable HCV RNA; Subset Analysis by Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse [ Time Frame: at the end of treatment ] [ Designated as safety issue: No ]
Proportion of Subjects with End of Treatment Response (undetectable HCV RNA at end of treatment), overall
Proportion of Subjects With Undetectable HCV RNA; Subset Analysis by Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse [ Time Frame: 48 weeks after completion of treatment ] [ Designated as safety issue: No ]
Proportion of Subjects with SVR48 among Subjects Completing Assigned Treatment, Overall
Cross Tabulation of eRVR and SVR Responses in Study 107 With Prior Null Response, Prior Partial Response, Prior Viral Breakthrough, and Prior Relapse [ Time Frame: throughout study ] [ Designated as safety issue: No ]
Number of subjects who achieved eRVR and/or SVR24

Enrollment:	117
Study Start Date:	October 2007
Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: T12/PR24 Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 12 weeks	Drug: telaprevir tablet Other Name: VX-950 Drug: ribavirin tablet Drug: Peg-interferon Alfa-2a Solution for Injection
Experimental: T12/PR48 Telaprevir + Peg-IFN + RBV for 12 weeks followed by Placebo + Peg-IFN + RBV for 36 weeks	Drug: telaprevir tablet Other Name: VX-950 Drug: ribavirin tablet Drug: Peg-interferon Alfa-2a Solution for Injection
Experimental: Other Subjects in this arm were receiving Telaprevir + Peg-IFN + RBV for 12 weeks. Subjects with a partial response, viral breakthrough, or relapse in the parent study, and who discontinued treatment before Week 12, were included in the "Other" treatment group.	Drug: telaprevir tablet Other Name: VX-950 Drug: ribavirin tablet Drug: Peg-interferon Alfa-2a Solution for Injection

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Enrolled in the control arm of Study VX06-950-106, VX05-950-104 or VX05-950-104EU

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00535847

Show 62 Study Locations

Sponsors and Collaborators

Vertex Pharmaceuticals Incorporated

Tibotec, Inc

Investigators

Study Director:

Nathalie Adda, MD

Vertex Pharmaceuticals Incorporated

More Information

No publications provided

Responsible Party:	Robert Kauffman, M.D., Ph.D., Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT00535847 History of Changes
Other Study ID Numbers:	VX06-950-107
Study First Received:	September 25, 2007
Results First Received:	June 22, 2011
Last Updated:	June 22, 2011
Health Authority:	United States: Food and Drug Administration Canada: Health Canada Germany: Federal Institute for Drugs and Medical Devices Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Vertex Pharmaceuticals Incorporated:

Genotype 1

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
Interferons
Ribavirin

Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013