A Phase 3 Study of Telaprevir in Combination With Pegasys® and Copegus® in Treatment-Naive Subjects With Genotype 1 HCV - Full Text View

Sponsors and Collaborators:	Vertex Pharmaceuticals Incorporated Tibotec Pharmaceutical Limited
Information provided by:	Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT00627926

Purpose

A phase 3 study to evaluate efficacy and safety of two dosing regimens of telaprevir in combination with Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®).

Condition	Intervention	Phase
Hepatitis C	Biological: Peg-Interferon-alfa-2a Drug: telaprevir Drug: placebo matching telaprevir Drug: Ribavirin	Phase III

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Peginterferon Alfa-2a Interferon alfa-n1 Interferon alfa-2a Interferons Telaprevir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3 Study of 2 Dose Regimens of Telaprevir in Combination With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Treatment-Naive Subjects With Genotype 1 Chronic Hepatitis C

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:

To demonstrate the efficacy of telaprevir in combination with Pegasys® and Copegus® in treatment naive subjects with genotype 1 chronic hepatitis C. [ Time Frame: Prospective ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the safety of telaprevir in combination with Pegasys® and Copegus® in treatment naive subjects with genotype 1 chronic hepatitis C. [ Time Frame: Prospective ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	1050
Study Start Date:	March 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Placebo matching telaprevir in combination with Pegasys® and Copegus® for 12 weeks, followed by 36 weeks of Pegasys® and Copegus®.	Biological: Peg-Interferon-alfa-2a Solution for injection Drug: placebo matching telaprevir tablet Drug: Ribavirin tablet
2: Active Comparator Telaprevir plus Pegasys® and Copegus® for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus Pegasys® and Copegus®. Followed by 16 to 36 weeks of Pegasys® and Copegus®, depending on individual response to telaprevir.	Biological: Peg-Interferon-alfa-2a Solution for injection Drug: telaprevir tablet Drug: placebo matching telaprevir tablet Drug: Ribavirin tablet
3: Active Comparator Telaprevir plus Pegasys® and Copegus® for 12 weeks, followed by 12 to 36 weeks of Pegasys® and Copegus®, depending on individual response to telaprevir.	Biological: Peg-Interferon-alfa-2a Solution for injection Drug: telaprevir tablet Drug: Ribavirin tablet

Eligibility

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

Criteria

Inclusion Criteria

Has not received any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C
Male and female subjects, 18 to 70 years of age, inclusive
Genotype 1, chronic hepatitis C with detectable HCV RNA.
Screening laboratory values, tests, and physical exam within acceptable ranges
Able and willing to follow contraception requirements
Able to read and understand, and willing to sign the informed consent form and abide by the study restrictions.

Exclusion Criteria

Subject has any contraindications to Pegasys® or Copegus® therapy
Evidence of hepatic decompensation in cirrhotic subjects
History of organ transplant
History of, or any current medical condition which could impact the safety of the subject in participation in the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00627926

Show 114 Study Locations

Sponsors and Collaborators

Vertex Pharmaceuticals Incorporated

Tibotec Pharmaceutical Limited

Investigators

Study Director:

Medical Monitor

Vertex Pharmaceuticals Incorporated

More Information

Responsible Party:	Vertex Pharmaceuticals Incorporated ( Shelley George, M.D. )
Study ID Numbers:	VX07-950-108
Study First Received:	February 22, 2008
Last Updated:	October 28, 2008
ClinicalTrials.gov Identifier:	NCT00627926
Health Authority:	United States: Food and Drug Administration

Keywords provided by Vertex Pharmaceuticals Incorporated:

Genotype 1

Study placed in the following topic categories:

Interferon-alpha
Liver Diseases
Hepatitis, Chronic
Ribavirin
Interferons
Hepatitis, Viral, Human
Hepatitis

Virus Diseases
Digestive System Diseases
Peginterferon alfa-2a
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Flaviviridae Infections
Immunologic Factors
Antineoplastic Agents
Growth Substances

Physiological Effects of Drugs
Antiviral Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009