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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1469

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2003

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2006

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2006

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2004

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2004

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2004

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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