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Trial information
A Study of Induction Dosing With PEGASYS (Peginterferon alfa-2a (40KD)) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C.
Status: No longer recruiting
Protocol number: NV18210
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study of the effect on sustained viral response, and the safety, of standard or 360 ug PEGASYS induction dosing in combination with standard or higher dose Copegus in treatment-naive chronic hepatitis C patients weighing >85kg with genotype 1 high viral titer infection
Brief summary: This 4 arm study will compare the efficacy and safety of PEGASYS induction and maintenance dosing, versus standard fixed dosing in combination with Copegus,and the efficacy and safety of higher dose versus standard dose Copegus in combination with PEGASYS. Patients with chronic hepatitis C genotype 1 infection of high viral titer, and baseline body weight >=85kg, will be randomized to one of 4 groups, to receive a)PEGASYS 180 micrograms sc weekly plus Copegus 1200mg po daily, b)PEGASYS 180 micrograms sc weekly plus Copegus 1400-1600mg po daily, c)PEGASYS 360 micrograms sc weekly (induction) followed by 180 micrograms sc weekly (maintenance) plus Copegus 1200mg po daily or d)PEGASYS 360 micrograms sc weekly (induction) followed by 180 micrograms sc weekly (maintenance) plus Copegus 1400-1600mg po daily. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals. Target sample size is 1140.
Study phase: IV
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety/Efficacy study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: peginterferon alfa-2a (40KD) [PEGASYS]
Primary outcome: 1. SVR Time frame: Week 72
Key secondary outcomes: 1. SVR Time frame: 24 weeks after end of treatment
2. Virological response Time frame: Week 48 and 60, and 12 weeks after end of treatment
3. AEs, laboratory parameters, Beck Depression Inventory Time frame: Throughout study
Inclusion criteria: - adult patients, >=18 years of age;
- CHC infection, genotype 1;
- HCV RNA >=400,000 IU/mL;
- baseline body weight >=85kg;
- liver biopsy (within 24 months of first dose) with results consistent with CHC.
Exclusion criteria: - previous treatment with interferon, ribavirin, viramidine, levovirin, HCV polymerase or protease inhibitors;
- other forms of liver disease, including liver cancer;
- human immunodeficiency virus infection.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: February, 2007
Trial registration date: 10/30/2006
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:Belgium Brazil - Caixa
- Campinas
- Juiz De Fora
- Porto Alegre
- Salvador
- Sao Jose do Rio Preto
- Sao Paulo
Canada - Edmonton, AB
- Vancouver, BC
- Winnipeg, MB
- Halifax, NS
- London, ON
- Ottawa, ON
- Toronto, ON
Denmark France - Clermont-Ferrand
- Clichy
- Lille
Germany - Bonn
- Düsseldorf
- Frankfurt Am Main
- Freiburg
- Giessen
- Hamburg
- Heidelberg
- Kiel
- Köln
- Tübingen
Hungary - Bekescsaba
- Budapest
- Debrecen
- Gyula
- Pecs
Netherlands Poland - Bydgoszcz
- Chorzow
- Kielce
- Lodz
- Warszawa
- Wroclaw
Romania - Bucharest
- Cluj-Napoca
- Constanta
- Iasi
- Timisoara
Russian Federation - Jaloslave
- Moscow
- Nizhny Novgorod
- Samara
- Smolensk
- St Petersburg
- Stavropol
Sweden United Kingdom - London
- Newcastle upon Tyne
- Southampton
United States - Birmingham, AL
- Huntsville, AL
- Anchorage, AK
- Phoenix, AZ
- Fresno, CA
- La Jolla, CA
- Lancaster, CA
- Los Angeles, CA
- Sacramento, CA
- San Diego , CA
- San Luis Obispo, CA
- San Marcos, CA
- Ventura, CA
- Aurora, CO
- Englewood, CO
- Washington, DC
- Jacksonville, FL
- Miami, FL
- North Miami Beach , FL
- Sarasota , FL
- Atlanta, GA
- Austell, GA
- Marietta, GA
- Honolulu, HI
- Chicago, IL
- Winfield, IL
- Indianapolis , IN
- Des Moines, IA
- Iowa City, IA
- Louisville, KY
- Baton Rouge, LA
- New Orleans, LA
- Boston, MA
- Worcester, MA
- Detroit, MI
- Ypsilanti, MI
- Plymouth, MN
- Kansas City, MO
- St Louis, MO
- Lebanon, NH
- Egg Harbour Township, NJ
- Vineland, NJ
- Bronx, NY
- Manhasset, NY
- New York, NY
- Rochester, NY
- Williamsville, NY
- Yonkers, NY
- Asheville, NC
- Chapel Hill, NC
- Fayetteville, NC
- Cincinnati, OH
- Cleveland, OH
- Tulsa , OK
- Medford, OR
- Lancaster, PA
- Philadelphia, PA
- Pittsburgh, PA
- Ponce, PR
- San Juan, PR
- Santurce, PR
- Cranston, RI
- Providence, RI
- Columbia, SC
- Germantown, TN
- West Nashville, TN
- Dallas, TX
- Fort Sam Houston, TX
- Houston, TX
- Salt Lake City, UT
- Annandale, VA
- Charlottesville, VA
- Chesapeake, VA
- Fairfax , VA
- Richmond, VA
- Seattle, WA
- Tacoma, WA
- Vancouver , WA
- Casper, WY
- Cheyenne, WY
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