Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C

PHASE3CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

January 31, 2012

Primary Completion Date

April 30, 2012

Study Completion Date

March 31, 2013

Conditions
Genotype 1 Chronic Hepatitis C
Interventions
DRUG

Telaprevir

Telaprevir Type = exact number, unit = mg, number = 750, form = tablet, route = oral. Telaprevir 750 mg (2 oral tablets) is taken every 8 hours for 12 weeks

DRUG

Pegylated-interferon-alfa-2a

Pegylated-interferon-alfa-2a type = exact number, unit = microgram, number = 180, form = injection, route = subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks

DRUG

Ribavirin

Ribavirin Type = exact, number = 1000 or 1200, unit = mg, form = tablet, route = oral. 1000mg (if participant's weight is \< 75kg) or 1200mg (if participant's weight is \>= 75kg) per day for 24 or 48 weeks.

Trial Locations (5)

Unknown

Moscow

Saint Petersburg

Samara

Smolensk

Stavropol

Sponsors
All Listed Sponsors
lead

Janssen-Cilag International NV

INDUSTRY