Clinical trial NCT00394277: A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C
Official title: Randomized, Multicenter, Double-blinded, Phase IV Study Evaluating the Efficacy (as Measured by Sustained Virological Response) and Safety of 360 μg Induction Dosing of Pegasys® in Combination With Higher Copegus® Doses in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 Virus Infection of High Viral Titer and Baseline Body Weight Greater Than or Equal to 85 kg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-10-31
Enrollment: 1175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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 (CHC) genotype 1 infection of high viral titer, and baseline body weight ≥85 kg, will be randomized to one of 4 groups, to receive one of the following: a) PEGASYS 180 µg subcutaneously (sc) weekly plus Copegus 1200 mg orally (po) daily; b) PEGASYS 180 µg sc weekly plus Copegus 1400-1600 mg po daily; c)PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1200 mg po daily; or d) PEGASYS 360 µg sc weekly (induction) followed by 180 µg sc weekly (maintenance) plus Copegus 1400-1600 mg 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.


Eligibility criteria: Inclusion Criteria:

* Adult patients, ≥18 years of age
* CHC infection, genotype 1
* Hepatitis C virus (HCV) RNA ≥400,000 IU/mL
* Baseline body weight ≥85 kg
* 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

Primary outcomes:
measure: Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)
timeFrame: Week 72
Secondary outcomes:
measure: SVR-24 (Actual Treatment Period)
timeFrame: 24 weeks after end of treatment
measure: SVR-12 (Scheduled Treatment Period)
timeFrame: 12 weeks after end of treatment
measure: SVR-12 (Actual Treatment Period)
timeFrame: 12 weeks after end of treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Huntsville
country: United States
state: Alabama
city: Anchorage
country: United States
state: Alaska
city: Phoenix
country: United States
state: Arizona
city: Fresno
country: United States
state: California
city: La Jolla
country: United States
state: California
city: Lancaster
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Luis Obispo
country: United States
state: California
city: San Marcos
country: United States
state: California
city: Ventura
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Washington
country: United States
state: District of Columbia
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: North Miami Beach
country: United States
state: Florida
city: Sarasota
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Austell
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Winfield
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Des Moines
country: United States
state: Iowa
city: Iowa City
country: United States
state: Iowa
city: Iowa City
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state: Iowa
city: Louisville
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state: Kentucky
city: Baton Rouge
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state: Louisiana
city: New Orleans
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state: Louisiana
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state: Massachusetts
city: Worcester
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city: Detroit
country: United States
state: Michigan
city: Ypsilanti
country: United States
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country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: St Louis
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state: Missouri
city: Lebanon
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state: New Hampshire
city: Egg Harbour Township
country: United States
state: New Jersey
city: Vineland
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state: New York
city: Manhasset
country: United States
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city: New York
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city: Rochester
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city: Williamsville
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state: North Carolina
city: Chapel Hill
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city: Fayetteville
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city: Cincinnati
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state: Ohio
city: Cleveland
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city: Cleveland
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state: Oklahoma
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state: Oregon
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country: United States
state: Pennsylvania
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city: Providence
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city: Columbia
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state: South Carolina
city: Germantown
country: United States
state: Tennessee
city: West Nashville
country: United States
state: Tennessee
city: Dallas
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city: Dallas
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city: Dallas
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state: Texas
city: Fort Sam Houston
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city: Salt Lake City
country: United States
state: Utah
city: Annandale
country: United States
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city: Charlottesville
country: United States
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country: United States
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city: Casper
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state: Wyoming
city: Cheyenne
country: United States
state: Wyoming
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Gent
country: Belgium
city: Leuven
country: Belgium
city: Caixa
country: Brazil
city: Campinas
country: Brazil
city: Juiz de Fora
country: Brazil
city: Porto Alegre
country: Brazil
city: Porto Alegre
country: Brazil
city: Salvador
country: Brazil
city: Sao Jose Do Rio Preto
country: Brazil
city: Sao Paulo
country: Brazil
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Halifax
country: Canada
state: Nova Scotia
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Kolding
country: Denmark
city: Odense
country: Denmark
city: Clermont-ferrand
country: France
city: Clichy
country: France
city: Lille
country: France
city: Lyon
country: France
city: Rouen
country: France
city: Strasbourg
country: France
city: Berlin
country: Germany
city: Bonn
country: Germany
city: Düsseldorf
country: Germany
city: Frankfurt Am Main
country: Germany
city: Freiburg
country: Germany
city: Giessen
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Heidelberg
country: Germany
city: Kiel
country: Germany
city: Köln
country: Germany
city: Tübingen
country: Germany
city: Bekescsaba
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Pecs
country: Hungary
city: Szombathely
country: Hungary
city: Amsterdam
country: Netherlands
city: Leiden
country: Netherlands
city: Rotterdam
country: Netherlands
city: Bydgoszcz
country: Poland
city: Chorzow
country: Poland
city: Kielce
country: Poland
city: Lodz
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Ponce
country: Puerto Rico
city: San Juan
country: Puerto Rico
city: Santurce
country: Puerto Rico
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Bucharest
country: Romania
city: Cluj-napoca
country: Romania
city: Constanta
country: Romania
city: Iasi
country: Romania
city: Timisoara
country: Romania
city: Jaloslave
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Moscow
country: Russian Federation
city: Nizhny Novgorod
country: Russian Federation
city: Samara
country: Russian Federation
city: Smolensk
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Stavropol
country: Russian Federation
city: Stockholm
country: Sweden
city: Uppsala
country: Sweden
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Southampton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Reddy KR, Shiffman ML, Rodriguez-Torres M, Cheinquer H, Abdurakhmanov D, Bakulin I, Morozov V, Silva GF, Geyvandova N, Stanciu C, Rabbia M, McKenna M, Thommes JA, Harrison SA; PROGRESS Study Investigators. Induction pegylated interferon alfa-2a and high dose ribavirin do not increase SVR in heavy patients with HCV genotype 1 and high viral loads. Gastroenterology. 2010 Dec;139(6):1972-83. doi: 10.1053/j.gastro.2010.08.051. Epub 2010 Sep 30.