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

Sponsor:	Vertex Pharmaceuticals Incorporated
Collaborator:	Tibotec Pharmaceutical Limited
Information provided by:	Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT00627926

Purpose

A Phase 3 study to evaluate the efficacy and safety of two dosing regimens of telaprevir in combination with peginterferon alfa-2a and ribavirin.

Condition	Intervention	Phase
Hepatitis C	Biological: peginterferon alfa-2a Drug: telaprevir Drug: ribavirin Other: placebo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C

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

U.S. FDA Resources

Further study details as provided by Vertex Pharmaceuticals Incorporated:

Primary Outcome Measures:

Proportion of Subjects Achieving Sustained Viral Response (SVR), Demonstrated by Achieving Undetectable HCV RNA 24 Weeks After Last Planned Dose of Study Treatment [ Time Frame: 24 weeks after last dose of study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of Subjects Who Have Undetectable HCV RNA at Week 72 [ Time Frame: 24 weeks after last planned dose for subjects with a planned treatment duration of 48 weeks, and 48 weeks after last planned dose for subjects with a planned treatment duration of 24 weeks ] [ Designated as safety issue: No ]
Proportion of Subjects Achieving a Rapid Viral Response (RVR), Demonstrated by Achieving Undetectable HCV RNA 4 Weeks After Starting Study Treatment [ Time Frame: 4 weeks after starting study treatment ] [ Designated as safety issue: No ]
Proportion of Subjects Achieving Extended Rapid Viral Response (eRVR), Demonstrated by Achieving Undetectable HCV RNA at Week 4 and at Week 12 [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: No ]
Proportion of Subjects Who Have Undetectable HCV RNA at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Proportion of Subjects Who Have Undetectable HCV RNA at the End of Treatment (EOT) [ Time Frame: Week 24 or Week 48, depending on planned treatment duration ] [ Designated as safety issue: No ]
Proportion of Subjects Who Have Undetectable HCV RNA 12 Weeks After Last Planned Dose of Study Treatment (SVR12Planned) [ Time Frame: 12 weeks after last planned dose of study treatment ] [ Designated as safety issue: No ]
Proportion of Subjects Who Have Undetectable HCV RNA 24 Weeks After Last Actual Dose of Study Treatment (SVR24Actual) [ Time Frame: 24 weeks after last actual dose of study treatment ] [ Designated as safety issue: No ]
Proportion of Subjects Who Relapse, Defined as Those Who Complete Treatment as Assigned, Have Undetectable HCV RNA at EOT, and Become HCV RNA Detectable During Antiviral Follow-up [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
Proportion of Subjects Who Relapse, Defined as Those Who Have Undetectable HCV RNA at the EOT, and Become HCV RNA Detectable During Antiviral Follow-up [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
Biochemical Response Including Transaminase Levels [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
Noninvasive Markers of Fibrosis [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
Total Fatigue Score From the Fatigue Severity Scale (FSS) [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
Adverse Events, Physical Examination Findings, and Clinical Laboratory, Vital Sign, and Electrocardiogram (ECG) Assessments [ Time Frame: Week 72 ] [ Designated as safety issue: No ]

Enrollment:	1095
Study Start Date:	March 2008
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo12/PR48 Placebo matching telaprevir in combination with peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin	Biological: peginterferon alfa-2a subcutaneous injection, 180 micrograms once per week Other Name: Pegasys, Peg-IFN Drug: ribavirin 200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing ≥75 kg Other Name: Copegus, RBV Other: placebo telaprevir-matching placebo
Experimental: T8/Placebo4/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 8 weeks, followed by 4 weeks of telaprevir matching placebo plus peginterferon alfa-2a and ribavirin, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.	Biological: peginterferon alfa-2a subcutaneous injection, 180 micrograms once per week Other Name: Pegasys, Peg-IFN Drug: telaprevir 375 mg tablets administered orally every 8 hours at a dose of 750 mg Other Name: TVR, VX-950 Drug: ribavirin 200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing ≥75 kg Other Name: Copegus, RBV Other: placebo telaprevir-matching placebo
Experimental: T12/PR24or48 Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 12 to 36 weeks of peginterferon alfa-2a and ribavirin, depending on individual response to telaprevir.	Biological: peginterferon alfa-2a subcutaneous injection, 180 micrograms once per week Other Name: Pegasys, Peg-IFN Drug: telaprevir 375 mg tablets administered orally every 8 hours at a dose of 750 mg Other Name: TVR, VX-950 Drug: ribavirin 200 mg tablets administered orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing ≥75 kg Other Name: Copegus, RBV

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 116 Study Locations

Sponsors and Collaborators

Vertex Pharmaceuticals Incorporated

Tibotec Pharmaceutical Limited

Investigators

Study Director:

Medical Monitor

Vertex Pharmaceuticals Incorporated

More Information

No publications provided by Vertex Pharmaceuticals Incorporated

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jacobson IM, McHutchison JG, Dusheiko G, Di Bisceglie AM, Reddy KR, Bzowej NH, Marcellin P, Muir AJ, Ferenci P, Flisiak R, George J, Rizzetto M, Shouval D, Sola R, Terg RA, Yoshida EM, Adda N, Bengtsson L, Sankoh AJ, Kieffer TL, George S, Kauffman RS, Zeuzem S; ADVANCE Study Team. Telaprevir for previously untreated chronic hepatitis C virus infection. N Engl J Med. 2011 Jun 23;364(25):2405-16.

Responsible Party:	Shelley George, M.D., Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:	NCT00627926 History of Changes
Other Study ID Numbers:	VX07-950-108
Study First Received:	February 22, 2008
Results First Received:	June 22, 2011
Last Updated:	June 22, 2011
Health Authority:	United States: Food and Drug Administration

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

Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2012