ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection.

January 22, 2016 updated by: Hoffmann-La Roche

A Randomized, Open-label Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Sustained Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 2 or 3 Infection

This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. 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)

1469

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

  • Australia
      • Adelaide, Australia, 5000
      • Brisbane, Australia, 4029
      • Kingswood, Australia
      • Melbourne, Australia, 3181
      • Woolloongabba, Australia, 4102
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
    • Ontario
      • Downsview, Ontario, Canada, M3N 2V7
      • Mississauga, Ontario, Canada, L5M 2V8
  • France
      • Clichy, France, 92118
      • Creteil, France, 94010
      • La Tronche, France, 38700
      • Marseille, France, 13285
      • Nice, France, 06202
      • Rennes, France, 35033
      • Strasbourg, France, 67091
      • Toulouse, France, 31059
      • Vandoeuvre-les-nancy, France, 54511
  • Germany
      • Berlin, Germany, 13353
      • Düsseldorf, Germany, 40225
      • Freiburg, Germany, 79106
      • Hannover, Germany, 30625
      • Homburg/saar, Germany, 66424
      • Kiel, Germany, 24105
  • Italy
      • Bergamo, Italy, 24128
      • Bologna, Italy, 40138
      • Milano, Italy, 20121
      • Napoli, Italy, 80131
      • Pavia, Italy, 27100
      • Pisa, Italy, 56124
  • New Zealand
      • Otahuhu, New Zealand
  • Puerto Rico
      • Ponce, Puerto Rico, 00716
      • San Juan, Puerto Rico, 00936-5067
      • San Juan, Puerto Rico, 00921-3200
      • Santurce, Puerto Rico, 00909
  • Spain
      • Badalona, Spain, 08915
      • Barakaldo, Spain, 48903
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08025
      • Madrid, Spain, 28006
      • Madrid, Spain, 28034
      • Madrid, Spain, 28007
      • Madrid, Spain, 08029
      • Sevilla, Spain, 41013
      • Valencia, Spain, 46014
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
      • Mobile, Alabama, United States, 36693
    • Alaska
      • Anchorage, Alaska, United States, 99508
    • Arizona
      • Phoenix, Arizona, United States, 85006
      • Scottsdale, Arizona, United States, 85259
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • La Jolla, California, United States, 92037-1030
      • Long Beach, California, United States, 90822
      • Los Angeles, California, United States, 90048
      • Palo Alto, California, United States, 94304-1509
      • Sacramento, California, United States, 95825-2115
      • San Diego, California, United States, 92123
      • San Diego, California, United States, 92154
      • San Diego, California, United States, 92105
      • San Francisco, California, United States, 94115
      • San Francisco, California, United States, 94121
      • San Luis Obispo, California, United States, 93401
    • Colorado
      • Littleton, Colorado, United States, 80120
    • Connecticut
      • Farmington, Connecticut, United States, 06030
    • Florida
      • Bradenton, Florida, United States, 34209
      • Gainesville, Florida, United States, 32610-0214
      • Jacksonville, Florida, United States, 32207
      • Jacksonville, Florida, United States, 32209
      • Miami, Florida, United States, 33136
      • Orlando, Florida, United States, 32803
      • Pensacola, Florida, United States, 32514
      • Tampa, Florida, United States, 33612
      • Wellington, Florida, United States, 33414
    • Georgia
      • Atlanta, Georgia, United States, 30309
      • Austell, Georgia, United States, 30106
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
    • Idaho
      • Boise, Idaho, United States, 83702
    • Illinois
      • Moline, Illinois, United States, 61265
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Iowa
      • Iowa City, Iowa, United States, 52242
      • Iowa City, Iowa, United States, 52246
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70805
      • New Orleans, Louisiana, United States, 70112
    • Maryland
      • Baltimore, Maryland, United States, 21201
      • Baltimore, Maryland, United States, 21205
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
      • Boston, Massachusetts, United States, 02720
      • Burlington, Massachusetts, United States, 01805
      • Worcester, Massachusetts, United States, 01655
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0362
      • Detroit, Michigan, United States, 48202-2689
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
      • Plymouth, Minnesota, United States, 55446
    • Missouri
      • St Louis, Missouri, United States, 63104
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
    • New York
      • Bayside, New York, United States, 11358
      • Binghamton, New York, United States, 13903
      • Bronx, New York, United States, 10468
      • Manhasset, New York, United States, 11030
      • New York, New York, United States, 10021
      • New York, New York, United States, 10003
      • Williamsville, New York, United States, 14221
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7584
      • Durham, North Carolina, United States, 27710
      • Fayetteville, North Carolina, United States, 28304
      • Statesville, North Carolina, United States, 28677
    • Ohio
      • Cincinnati, Ohio, United States, 45267-0595
      • Cleveland, Ohio, United States, 44106
    • Oregon
      • Portland, Oregon, United States, 97220
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
      • Lancaster, Pennsylvania, United States, 17604-3200
      • Pittsburgh, Pennsylvania, United States, 15213
    • Rhode Island
      • Cranston, Rhode Island, United States, 02920
      • Providence, Rhode Island, United States, 02905
    • Tennessee
      • Germantown, Tennessee, United States, 38138
    • Texas
      • Dallas, Texas, United States, 75203
      • Dallas, Texas, United States, 75235-9151
      • Fort Sam Houston, Texas, United States, 78234-3879
      • Houston, Texas, United States, 77030
    • Utah
      • Salt Lake City, Utah, United States, 84121
    • Vermont
      • White River Junction, Vermont, United States, 05009-0001
    • Virginia
      • Charlottesville, Virginia, United States, 22902
      • Chesapeake, Virginia, United States, 23320-1706
      • Falls Church, Virginia, United States, 22042
      • Richmond, Virginia, United States, 23249
    • Washington
      • Bellevue, Washington, United States, 98004
      • Kirkland, Washington, United States, 98034
      • Puyallup, Washington, United States, 98372
      • Seattle, Washington, United States, 98133
      • Seattle, Washington, United States, 98195
      • Spokane, Washington, United States, 99220-3649
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
    • Wyoming
      • 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:

  • patients >=18 years of age;
  • CHC infection (genotype 2 or 3);
  • liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;
  • use of 2 forms of contraception during study and 6 months after the study in both men and women.

Exclusion Criteria:

  • women who are pregnant or breastfeeding;
  • male partners of women who are pregnant;
  • conditions associated with decompensated liver disease;
  • other forms of liver disease, including liver cancer;
  • human immunodeficiency virus infection;
  • previous treatment with an IFN, pegylated IFN, ribavirin, viramidine, levovirin, or amantadine.

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: Copegus
400mg po bid for 16 weeks
Drug: Copegus
400mg po bid for 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 16 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 24 weeks
Experimental: 2
Drug: Copegus
400mg po bid for 16 weeks
Drug: Copegus
400mg po bid for 24 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 16 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virological Response (SVR)
Time Frame: Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)
SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.
Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Virological Response at The End of Study Treatment
Time Frame: Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)
Virological response was defined as the percentage of participants with undetectable HCV RNA at the completion of the study treatment. The negative assessment was required to be the last one collected in the Week 16 time window for the 16-week treatment group or in the Week 24 time window for the 24-week treatment group.
Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)
Percentage of Participants Virological Response 12 Weeks Post-Treatment
Time Frame: Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)
Virological response 12 weeks post-treatment was defined as the percentage of participants with undetectable HCV RNA 12 weeks after the completion of the study treatment . The negative assessment was required to be the last one collected in the week 28 time window for the 16- week treatment group or in the week 36 time window for the 24-week treatment group.
Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to Week 40 and Week 48
An adverse event was defined as any untoward medical occurrence that occurred during he course of the trial after study treatment had started. An adverse event was therefore any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
Up to Week 40 and Week 48
Percentage of Participants With Marked Laboratory Abnormalities
Time Frame: Up to Week 40 and Week 48
Participants with changes in Hematocrit: Fraction 0.36 - 0.60 g/dL, Hemoglobin: 11.0 -20.0 g/dL, WBC 3.0 - 18.0 g/dL, Platelets 100 - 700 g/dL, Basophils 0.00 - 0.30 g/dL, Lymphocytes 1.00 - 6.30 g/dL, Monocytes 0.08 - 2.00 g/dL, Neutrophils 1.50 or more g/dL, Eosinophils 0.00 - 1.50 g/dL , PTT 0 - 50 seconds, Alkaline Phosphatase 0 - 190 and ASAT 0 - 50 U/L, ALAT 0 - 60 U/L, Gamma - GT 0 - 120 U/L, Total Protein 55 - 87 g/L ;Albumin 27.0 or more g/L, Total Bilirubin 0 - 34.2 μmol/L, BUN 0 - 14.3 mmol/L, Creatinine 0 - 154 μmol/L, Free T3, T4 5 - 40 pmol/L, TSH 0.0 - 10.0 mU/L, Cholesterol 0.0 - 8.3 mmol/L; Triglycerides 0.00 - 2.83 mmol/L, Chloride 95 - 115 mmol/L; Potassium 3.0 - 6.0 mmol/L; Sodium 130 - 150 mmol/L, miscellaneous: Calcium 2.00 - 2.90 mmol/L; Phosphate 0.75 - 1.60 mmol/L; Blood Glucose (Random) 2.80 - 11.10 mmol/L, Uric Acid 0 - 600 μmol/L, Proteinuria, Glycosuria, Hematuria (Qualitative 0 to 4+) 0 - 1 were analysed for the laboratory abnormality.
Up to Week 40 and Week 48
Participants With Marked Abnormal Vital Signs
Time Frame: Up to Week 40 and Week 48
Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.
Up to Week 40 and Week 48
Number of Participants With Highest Triglyceride Level
Time Frame: Up to Week 40 and Week 48
Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed.
Up to Week 40 and Week 48

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

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

December 1, 2003

Primary Completion (Actual)

March 1, 2006

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

February 10, 2004

First Submitted That Met QC Criteria

February 12, 2004

First Posted (Estimate)

February 13, 2004

Study Record Updates

Last Update Posted (Estimate)

February 23, 2016

Last Update Submitted That Met QC Criteria

January 22, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NV17317

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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