Phase 2 Study of VX-950, Pegasys®, and Copegus® in Hepatitis C

Browse trials for

• Hepatitis A 2,709
• Hepatitis C 2,321
• Hepatitis C, Chronic 1,073
• Hepatitis 3,380

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 263 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Lead sponsor

Vertex Pharmaceuticals Incorporated is the lead sponsor of 243 studies on the registry; 19 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 49 (48%) have results posted.

Study arms

• 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) tablet 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.

  Drug: Ribavirin · Drug: Pegylated Interferon Alfa 2a · Other: Placebo

• Experimental
  Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week

  Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet 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 48 weeks.

  Drug: Telaprevir · Drug: Ribavirin · Drug: Pegylated Interferon Alfa 2a

• 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 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.

  Drug: Telaprevir · Drug: Ribavirin · Drug: Pegylated Interferon Alfa 2a

• 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.

  Drug: Telaprevir · Drug: Ribavirin · Drug: Pegylated Interferon Alfa 2a

Interventions

• DrugTelaprevir

  tablet

  Also known as: VX-950

• DrugRibavirin

  tablet

  Also known as: RBV

• DrugPegylated Interferon Alfa 2a

  Solution for injection

  Also known as: Peg-IFN-alfa-2a

• OtherPlacebo

  matching placebo tablet

Primary outcomes

1. Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing

   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).

   Time frame: 24 weeks after the completion of study drug dosing (up to Week 72)

Secondary outcomes

1. Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing

   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).

   Time frame: 12 weeks after the completion of study drug dosing (up to Week 60)

2. Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)

   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.

   Time frame: Baseline up to Week 48

3. Number of Subjects With Viral Relapse

   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).

   Time frame: After last dose of study drug up to antiviral follow-up (up to Week 72)

4. Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir

   Only subjects who received telaprevir were to be analyzed for this outcome. Maximum, minimum and average plasma concentrations observed during assessment period were reported.

   Time frame: Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85

Baseline characteristics

Publications

• McHutchison JG, Everson GT, Gordon SC, Jacobson IM, Sulkowski M, Kauffman R, McNair L, Alam J, Muir AJ; PROVE1 Study Team. Telaprevir with peginterferon and ribavirin for chronic HCV genotype 1 infection. N Engl J Med. 2009 Apr 30;360(18):1827-38. doi: 10.1056/NEJMoa0806104. Erratum In: N Engl J Med. 2009 Oct 8;361(15):1516. PubMed 19403902 ↗