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VX-950-C211 - A Dosing Regimen Study (Twice Daily Versus Every 8 Hours) of Telaprevir in Treatment-naive Patients With Genotype 1 Chronic Hepatitis C Virus Infection.

This study has been completed.
Sponsor:
Collaborator:
Vertex Pharmaceuticals Incorporated
Information provided by (Responsible Party):
Janssen Infectious Diseases BVBA
ClinicalTrials.gov Identifier:
NCT01241760
First received: October 28, 2010
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to evaluate the effectiveness of telaprevir administered twice daily versus every 8 hours in combination with Peg-IFN-alfa-2a and ribavirin in treatment-naÃ-ve patients with chronic HCV genotype 1 infection.


Condition Intervention Phase
Genotype 1 Chronic Hepatitis C
Treatment Naive
 Drug: Ribavirin
Drug: Telaprevir
Drug: Pegylated interferon alfa-2a
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Phase 3 Study of Telaprevir Administered Twice Daily or Every 8 Hours in Combination With Pegylated Interferon Alfa-2a and Ribavirin in Treatment-naive Subjects With Genotype 1 Chronic Hepatitis C Virus Infection.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Janssen Infectious Diseases BVBA:

Primary Outcome Measures:
  • Proportion of patients achieving undetectable plasma HCV ribonucleic acid (RNA) levels. [ Time Frame: 24 weeks after the last planned dose of study drugs. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety and tolerability of the 2 dose regimens of telaprevir. [ Time Frame: 24 weeks after last planned intake of study medication. ] [ Designated as safety issue: No ]
  • The effect of IL28B genotype on viral response. [ Time Frame: 24 weeks after last planned intake of study medication ] [ Designated as safety issue: No ]
  • The pharmacokinetics of telaprevir, Peg-IFN-alpha-2a, and ribavirin and pharmacokinetic-pharmacodynamic relationships for safety and efficacy. [ Time Frame: 24 weeks after last planned intake of study medication ] [ Designated as safety issue: No ]
  • The changes from baseline in the amino acid sequence of the HCV NS3-4A region. [ Time Frame: 24 weeks after last planned intake of study medication ] [ Designated as safety issue: No ]

Enrollment: 748
Study Start Date: December 2010
Study Completion Date: November 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks
 Drug: Telaprevir
750 mg (2 oral tablets) every 8 hours for 12 weeks
Experimental: 002
Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
 Drug: Telaprevir
1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
003
Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
 Drug: Pegylated interferon alfa-2a
180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks
004
Ribavirin 1 000-1 200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
 Drug: Ribavirin
depending on the patient's treatment response at week 4

Detailed Description:

This is a randomised (study drug assigned by chance), open-label (all persons know the study drug assignment) multicenter study to evaluate the effectiveness of telaprevir administered orally as 1125 milligram (mg) twice daily versus 750mg every 8 hours in combination with Peg-IFN-alfa-2a, administered via intramuscular injection once a week, and ribavirin, administered as an oral tablet twice a day, in treatment-naïve patients with chronic HCV genotype 1 infection. Telaprevir will be given orally (by mouth) from Day 1 through Week 12 as 3 tablets (1125mg) twice daily or 2 tablets (750mg) every 8 hours. Peg-IFN-alfa-2a will be administered once a week as an injection under the skin (180 microgram/week) from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4). Ribavirin is administered orally (by mouth) twice daily from Day 1 through Week 24 or 48 (based on the patient's treatment response on week 4) as 1,000-1,200mg per day.

  Eligibility

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

Inclusion Criteria:

  • Patient has chronic HCV infection genotype 1 with HCV RNA level > 1,000 IU/mL
  • Patients should not have had any previous treatment for hepatitis C
  • Patient must have documentation of a liver biopsy within 2 years before the screening visit or the patient must agree to have a biopsy performed within the screening period
  • Patients with cirrhosis should have serum alpha-fetoprotein (AFP) <= 50 ng/mL. If AFP > 50 ng/mL, absence of a mass must be demonstrated by ultrasound within the screening period
  • A female patient of childbearing potential and a nonvasectomized male patient who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female patient) or 7 months (male patient) after the last dose of RBV.

Exclusion Criteria:

  • Patient is infected or co-infected with HCV of another genotype than genotype 1 and/or patient is infected with more than one genotype subtype
  • Patient has a pre-existing psychiatric condition
  • Patient has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
  • Patient has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
  • Patient has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01241760

  Show 97 Study Locations
Sponsors and Collaborators
Janssen Infectious Diseases BVBA
Vertex Pharmaceuticals Incorporated
Investigators
Study Director: Janssen Infectious Diseases BVBA Clinical Trial Janssen Infectious Diseases BVBA
  More Information

No publications provided

Responsible Party: Janssen Infectious Diseases BVBA
ClinicalTrials.gov Identifier: NCT01241760     History of Changes
Other Study ID Numbers: CR013711, OPTIMIZE-HCV, VX-950-C211
Study First Received: October 28, 2010
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration
USA: FOOD AND DRUG ADMINISTRATION - CENTER FOR DRUG EVALUATION AND RESEARCH
Germany: Ethics Commission
Great Britain: Medicines and Healthcare Products Regulatory Agency
Ireland: Irish Medicines Board

Keywords provided by Janssen Infectious Diseases BVBA:
VX-950-C211
VX-950
Telaprevir
Hepatitis C
 BID
Q8h
SOC

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Virus Diseases
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
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

ClinicalTrials.gov processed this record on May 16, 2013