A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C

July 30, 2010 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1175

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1070
      • Bruxelles, Belgium, 1200
      • Bruxelles, Belgium, 1000
      • Bruxelles, Belgium, 1030
      • Gent, Belgium, 9000
      • Leuven, Belgium, 3000
  • Brazil
      • Caixa, Brazil, 18618-970
      • Campinas, Brazil, 13083-888
      • Juiz de Fora, Brazil, 36036-330
      • Porto Alegre, Brazil, 90035-003
      • Porto Alegre, Brazil, 91350-200
      • Salvador, Brazil, 40110-170
      • Sao Jose Do Rio Preto, Brazil, 15090-000
      • Sao Paulo, Brazil, 01307
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
    • Ontario
      • London, Ontario, Canada, N6A 5A5
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M5G 1L7
      • Toronto, Ontario, Canada, M5G 1X5
      • Toronto, Ontario, Canada, M6H 3M1
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
  • Denmark
      • Kolding, Denmark, 6000
      • Odense, Denmark, 5000
  • France
      • Clermont-ferrand, France, 63000
      • Clichy, France, 92118
      • Lille, France, 59037
      • Lyon, France, 69288
      • Rouen, France, 76031
      • Strasbourg, France, 67091
  • Germany
      • Berlin, Germany, 13353
      • Bonn, Germany, 531105
      • Düsseldorf, Germany, 40225
      • Frankfurt Am Main, Germany, 60590
      • Freiburg, Germany, 79106
      • Giessen, Germany, 35392
      • Hamburg, Germany, 20246
      • Hannover, Germany, 30625
      • Heidelberg, Germany, 69120
      • Kiel, Germany, 24105
      • Köln, Germany, 50924
      • Tübingen, Germany, 72076
  • Hungary
      • Bekescsaba, Hungary, 5600
      • Budapest, Hungary, 1083
      • Budapest, Hungary, 1097
      • Debrecen, Hungary, 4032
      • Gyor, Hungary, 9024
      • Gyula, Hungary, 5700
      • Pecs, Hungary, 7654
      • Szombathely, Hungary, 9700
  • Netherlands
      • Amsterdam, Netherlands, 1091 AC
      • Leiden, Netherlands, 2333 ZA
      • Rotterdam, Netherlands, 3015 GD
  • Poland
      • Bydgoszcz, Poland, 85-030
      • Chorzow, Poland, 41-500
      • Kielce, Poland, 25-317
      • Lodz, Poland, 91-347
      • Warszawa, Poland, 01-201
      • Wroclaw, Poland, 51-124
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
      • San Juan, Puerto Rico, 00936-5067
      • Santurce, Puerto Rico, 00909
  • Romania
      • Bucharest, Romania, 021105
      • Bucharest, Romania, 022328
      • Bucharest, Romania, 010825
      • Bucharest, Romania, 030303
      • Cluj-napoca, Romania
      • Constanta, Romania
      • Iasi, Romania, 700111
      • Timisoara, Romania
  • Russian Federation
      • Jaloslave, Russian Federation
      • Moscow, Russian Federation, 105229
      • Moscow, Russian Federation, 143420
      • Moscow, Russian Federation, 115446
      • Moscow, Russian Federation, 119881
      • Moscow, Russian Federation, 11/5
      • Moscow, Russian Federation, 117333
      • Moscow, Russian Federation, 127009
      • Nizhny Novgorod, Russian Federation, 603022
      • Samara, Russian Federation, 443011
      • Smolensk, Russian Federation, 214006
      • St Petersburg, Russian Federation, 194044
      • Stavropol, Russian Federation, 355017
  • Sweden
      • Stockholm, Sweden
      • Uppsala, Sweden, 75185
  • United Kingdom
      • London, United Kingdom, SE5 9RS
      • London, United Kingdom, SW17 0QT
      • London, United Kingdom, SW10 9TH
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
      • Plymouth, United Kingdom, PL6 8DH
      • Southampton, United Kingdom, SO16 6YD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
      • Huntsville, Alabama, United States, 35801
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Phoenix, Arizona, United States, 85006
    • California
      • Fresno, California, United States, 93721
      • La Jolla, California, United States, 92037-1030
      • Lancaster, California, United States, 93534
      • Los Angeles, California, United States, 90095
      • Los Angeles, California, United States, 90045
      • Sacramento, California, United States, 95817
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92103-8465
      • San Diego, California, United States, 92154
      • San Diego, California, United States, 92105
      • San Luis Obispo, California, United States, 93401
      • San Marcos, California, United States, 92069
      • Ventura, California, United States, 93003
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Englewood, Colorado, United States, 80113
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
      • Washington, District of Columbia, United States, 20037
    • Florida
      • Jacksonville, Florida, United States, 32256
      • Jacksonville, Florida, United States, 32209
      • Miami, Florida, United States, 33136-1051
      • North Miami Beach, Florida, United States, 33162
      • Sarasota, Florida, United States, 34243
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Austell, Georgia, United States, 30106
      • Marietta, Georgia, United States, 30060
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
    • Illinois
      • Chicago, Illinois, United States, 60637
      • Chicago, Illinois, United States, 60612
      • Winfield, Illinois, United States, 60190
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Iowa
      • Des Moines, Iowa, United States, 50312
      • Iowa City, Iowa, United States, 52246
      • Iowa City, Iowa, United States, 52242-1081
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70805
      • New Orleans, Louisiana, United States, 70112
    • Massachusetts
      • Boston, Massachusetts, United States, 02720
      • Worcester, Massachusetts, United States, 01068
    • Michigan
      • Detroit, Michigan, United States, 48210
      • Ypsilanti, Michigan, United States, 48197
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
    • Missouri
      • Kansas City, Missouri, United States, 64131
      • St Louis, Missouri, United States, 63110
      • St Louis, Missouri, United States, 63104
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • New Jersey
      • Egg Harbour Township, New Jersey, United States, 08234
      • Vineland, New Jersey, United States, 08360
    • New York
      • Bronx, New York, United States, 10467
      • Manhasset, New York, United States, 11030
      • New York, New York, United States, 10021
      • New York, New York, United States, 10029
      • Rochester, New York, United States, 14618
      • Williamsville, New York, United States, 14221
      • Yonkers, New York, United States, 10701
    • North Carolina
      • Asheville, North Carolina, United States, 28801
      • Chapel Hill, North Carolina, United States, 27599-7080
      • Fayetteville, North Carolina, United States, 28304
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44109
      • Cleveland, Ohio, United States, 44106
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
    • Oregon
      • Medford, Oregon, United States, 97504
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604-3200
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
      • Pittsburgh, Pennsylvania, United States, 15213
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
      • Providence, Rhode Island, United States, 02903
    • South Carolina
      • Columbia, South Carolina, United States, 29204
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • West Nashville, Tennessee, United States, 37205
    • Texas
      • Dallas, Texas, United States, 75246
      • Dallas, Texas, United States, 75203
      • Dallas, Texas, United States, 75390-9034
      • Fort Sam Houston, Texas, United States, 78234-3879
      • Houston, Texas, United States, 77030
    • Utah
      • Salt Lake City, Utah, United States, 84121
    • Virginia
      • Annandale, Virginia, United States, 22003
      • Charlottesville, Virginia, United States, 22906-0013
      • Chesapeake, Virginia, United States, 23320-1706
      • Fairfax, Virginia, United States, 22031
      • Richmond, Virginia, United States, 23249
    • Washington
      • Seattle, Washington, United States, 98104
      • Tacoma, Washington, United States, 98405
      • Vancouver, Washington, United States, 98664
    • Wyoming
      • Casper, Wyoming, United States, 82609
      • Cheyenne, Wyoming, United States, 82001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PEG-IFN 180 µg + Ribavirin 1200 mg
Drug: peginterferon alfa-2a
180 µg sc weekly for 48 weeks
Other Names:
  • Pegasys
Drug: Ribavirin
1200 mg po daily for 48 weeks
Other Names:
  • Copegus
Drug: peginterferon alfa-2a
360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
Other Names:
  • Pegasys
Drug: Ribavirin
1400-1600 mg po daily for 48 weeks
Other Names:
  • Copegus
Experimental: PEG-IFN 180 µg + Ribavirin 1400/1600 mg
Drug: peginterferon alfa-2a
180 µg sc weekly for 48 weeks
Other Names:
  • Pegasys
Drug: Ribavirin
1200 mg po daily for 48 weeks
Other Names:
  • Copegus
Drug: peginterferon alfa-2a
360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
Other Names:
  • Pegasys
Drug: Ribavirin
1400-1600 mg po daily for 48 weeks
Other Names:
  • Copegus
Experimental: PEG-IFN 360/180 µg + Ribavirin 1200 mg
Drug: peginterferon alfa-2a
180 µg sc weekly for 48 weeks
Other Names:
  • Pegasys
Drug: Ribavirin
1200 mg po daily for 48 weeks
Other Names:
  • Copegus
Drug: peginterferon alfa-2a
360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
Other Names:
  • Pegasys
Drug: Ribavirin
1400-1600 mg po daily for 48 weeks
Other Names:
  • Copegus
Experimental: PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg
Drug: peginterferon alfa-2a
180 µg sc weekly for 48 weeks
Other Names:
  • Pegasys
Drug: Ribavirin
1200 mg po daily for 48 weeks
Other Names:
  • Copegus
Drug: peginterferon alfa-2a
360 µg sc weekly decreasing to 180 µg sc weekly for 48 weeks
Other Names:
  • Pegasys
Drug: Ribavirin
1400-1600 mg po daily for 48 weeks
Other Names:
  • Copegus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sustained Virological Response (SVR)-24 (Scheduled Treatment Period)
Time Frame: Week 72
SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 68 (ie, on or after study day 477).
Week 72

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SVR-24 (Actual Treatment Period)
Time Frame: 24 weeks after end of treatment
SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug.
24 weeks after end of treatment
SVR-12 (Scheduled Treatment Period)
Time Frame: 12 weeks after end of treatment
SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR <15 IU/mL measured at or after week 60).
12 weeks after end of treatment
SVR-12 (Actual Treatment Period)
Time Frame: 12 weeks after end of treatment
SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug.
12 weeks after end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

October 30, 2006

First Submitted That Met QC Criteria

October 30, 2006

First Posted (Estimate)

October 31, 2006

Study Record Updates

Last Update Posted (Estimate)

August 3, 2010

Last Update Submitted That Met QC Criteria

July 30, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NV18210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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