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Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vertex Pharmaceuticals Incorporated
ClinicalTrials.gov Identifier:
NCT00372385
First received: September 1, 2006
Last updated: June 25, 2014
Last verified: June 2014

September 1, 2006
June 25, 2014
August 2006
May 2008   (final data collection date for primary outcome measure)
Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing [ Time Frame: 24 weeks after the completion of study drug dosing (up to Week 72) ] [ Designated as safety issue: No ]
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).
Plasma HCV RNA 24 weeks post-treatment
Complete list of historical versions of study NCT00372385 on ClinicalTrials.gov Archive Site
  • Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing [ Time Frame: 12 weeks after the completion of study drug dosing (up to Week 60) ] [ Designated as safety issue: No ]
    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).
  • Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing [ Time Frame: Completion of study drug dosing (up to Week 48) ] [ Designated as safety issue: No ]
    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).
  • Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Week 48 ] [ Designated as safety issue: Yes ]
    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.
  • Number of Subjects With Viral Relapse [ Time Frame: After last dose of study drug up to antiviral follow-up (up to Week 72) ] [ Designated as safety issue: No ]
    Viral relapse was defined as having detectable HCV RNA during antiviral follow-up. 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).
  • Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir [ Time Frame: Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85 ] [ Designated as safety issue: No ]
    Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.
  • Plasma HCV RNA at other timepoints
  • Safety Assessment
  • Analysis of viral variants
  • VX-950, Peg-IFN-a-2a, and RBV pharmacokinetics
Not Provided
Not Provided
 
Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C
A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With and Without Ribavirin (Copegus®) in Subjects With Hepatitis C

Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Hepatitis C
  • Drug: Ribavirin
    tablet
  • Drug: Pegylated Interferon Alfa 2a
    Solution for injection
  • Drug: Placebo
    tablet
  • Drug: Telaprevir
    tablet
    Other Name: VX-950
  • Placebo Comparator: PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
    Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
    Interventions:
    • Drug: Ribavirin
    • Drug: Pegylated Interferon Alfa 2a
    • Drug: Placebo
  • Experimental: Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
    Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
    Interventions:
    • Drug: Ribavirin
    • Drug: Pegylated Interferon Alfa 2a
    • Drug: Telaprevir
  • Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
    Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
    Interventions:
    • Drug: Ribavirin
    • Drug: Pegylated Interferon Alfa 2a
    • Drug: Telaprevir
  • Experimental: Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week
    Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
    Interventions:
    • Drug: Pegylated Interferon Alfa 2a
    • Drug: Telaprevir
Hézode C, Forestier N, Dusheiko G, Ferenci P, Pol S, Goeser T, Bronowicki JP, Bourlière M, Gharakhanian S, Bengtsson L, McNair L, George S, Kieffer T, Kwong A, Kauffman RS, Alam J, Pawlotsky JM, Zeuzem S; PROVE2 Study Team. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med. 2009 Apr 30;360(18):1839-50.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
334
June 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
  • Have been infected with Hepatitis C virus for greater than (>) 6 months
  • Seronegative for hepatitis B surface antigen and human immunodeficiency virus 1 and 2
  • Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
  • Female subjects must have a negative pregnancy test at all visits before the first dose.

Exclusion Criteria:

  • Received any approved or investigational drug or drug regimen for the treatment of hepatitis C.
  • Any medical contraindications to Peg-IFN-alfa-2a or Ribavirin therapy
  • Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis or primary biliary cirrhosis.
  • Diagnosed or suspected hepatocellular carcinoma.
  • Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before Study start.
  • Alcohol/drug abuse or excessive use in the last 12 months.
  • Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria,   France,   Germany,   United Kingdom
 
NCT00372385
VX05-950-104EU
Yes
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
Not Provided
Study Director: Medical Monitor Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP