Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C
Status and phase
Completed
Phase 2
Conditions
Chronic Hepatitis C
Treatments
Drug: Ribavirin
Drug: Placebo
Drug: Telaprevir
Drug: Pegylated Interferon Alfa 2a
Details and patient eligibility
About
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
Enrollment
334 patients
Sex
All
Ages
18 to 65 years old
Volunteers
No Healthy Volunteers
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).
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Quadruple Blind
334 participants in 4 patient groups, including a placebo group
PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week
Placebo Comparator group
Description:
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.
Treatment:
Drug: Pegylated Interferon Alfa 2a
Drug: Placebo
Drug: Ribavirin
Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week
Experimental group
Description:
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.
Treatment:
Drug: Pegylated Interferon Alfa 2a
Drug: Telaprevir
Drug: Ribavirin
Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week
Experimental group
Description:
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.
Treatment:
Drug: Pegylated Interferon Alfa 2a
Drug: Telaprevir
Drug: Ribavirin
Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week
Experimental group
Description:
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.
Treatment:
Drug: Pegylated Interferon Alfa 2a
Drug: Telaprevir
Trial contacts and locations
4
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Data sourced from clinicaltrials.gov
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