Hepatitis C, ChronicPhase 4NCT00077636
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.
A Phase 4 study testing Copegus and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 132 sites in 9 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- Copegus and peginterferon alfa-2a [Pegasys]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,469 participants
- Where
- 132 sitesin 9 countries
- Study dates
- Dec 2003to Mar 2006
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
132 sites in 9 countries.
132 sites in 9 countries
United States88 sites
Study site
Albuquerque, New Mexico, 87108
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Anchorage, Alaska, 99508
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Ann Arbor, Michigan, 48109-0362
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Atlanta, Georgia, 30309
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Austell, Georgia, 30106
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Baltimore, Maryland, 21201
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Baltimore, Maryland, 21205
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Baton Rouge, Louisiana, 70805
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Bayside, New York, 11358
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Bellevue, Washington, 98004
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Binghamton, New York, 13903
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Birmingham, Alabama, 35294
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Boise, Idaho, 83702
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Boston, Massachusetts, 02118
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Boston, Massachusetts, 02720
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Bradenton, Florida, 34209
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Burlington, Massachusetts, 01805
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Chapel Hill, North Carolina, 27599-7584
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Charlottesville, Virginia, 22902
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Chesapeake, Virginia, 23320-1706
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Cheyenne, Wyoming, 82001
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Cincinnati, Ohio, 45267-0595
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Cleveland, Ohio, 44106
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Cranston, Rhode Island, 02920
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Dallas, Texas, 75203
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Dallas, Texas, 75235-9151
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Detroit, Michigan, 48202-2689
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Durham, North Carolina, 27710
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Falls Church, Virginia, 22042
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Farmington, Connecticut, 06030
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Fayetteville, North Carolina, 28304
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Fort Sam Houston, Texas, 78234-3879
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Gainesville, Florida, 32610-0214
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Germantown, Tennessee, 38138
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Hershey, Pennsylvania, 17033
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Honolulu, Hawaii, 96817
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Houston, Texas, 77030
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Indianapolis, Indiana, 46202
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Iowa City, Iowa, 52242
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Iowa City, Iowa, 52246
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Jacksonville, Florida, 32207
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Jacksonville, Florida, 32209
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Kirkland, Washington, 98034
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La Jolla, California, 92037-1030
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Lancaster, Pennsylvania, 17604-3200
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Little Rock, Arkansas, 72205
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Littleton, Colorado, 80120
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Long Beach, California, 90822
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Los Angeles, California, 90048
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Madison, Wisconsin, 53792
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Manhasset, New York, 11030
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Miami, Florida, 33136
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Minneapolis, Minnesota, 55417
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Mobile, Alabama, 36693
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Moline, Illinois, 61265
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New Orleans, Louisiana, 70112
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New York, New York, 10003
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New York, New York, 10021
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Orlando, Florida, 32803
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Palo Alto, California, 94304-1509
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Pensacola, Florida, 32514
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Phoenix, Arizona, 85006
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Pittsburgh, Pennsylvania, 15213
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Plymouth, Minnesota, 55446
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Portland, Oregon, 97220
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Providence, Rhode Island, 02905
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Puyallup, Washington, 98372
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Richmond, Virginia, 23249
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Sacramento, California, 95825-2115
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Salt Lake City, Utah, 84121
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San Diego, California, 92105
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San Diego, California, 92123
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San Diego, California, 92154
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San Francisco, California, 94115
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San Francisco, California, 94121
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San Luis Obispo, California, 93401
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Scottsdale, Arizona, 85259
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Seattle, Washington, 98133
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Seattle, Washington, 98195
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Spokane, Washington, 99220-3649
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St Louis, Missouri, 63104
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Statesville, North Carolina, 28677
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Tampa, Florida, 33612
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The Bronx, New York, 10468
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Wellington, Florida, 33414
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White River Junction, Vermont, 05009-0001
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Williamsville, New York, 14221
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Worcester, Massachusetts, 01655
Spain10 sites
Study site
Badalona, 08915
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Barakaldo, 48903
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Barcelona, 08003
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Barcelona, 08025
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Madrid, 08029
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Madrid, 28006
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Madrid, 28007
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Madrid, 28034
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Seville, 41013
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Valencia, 46014
France9 sites
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Clichy, 92118
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Créteil, 94010
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La Tronche, 38700
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Marseille, 13285
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Nice, 06202
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Rennes, 35033
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Strasbourg, 67091
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Toulouse, 31059
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Vandœuvre-lès-Nancy, 54511
Germany6 sites
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Berlin, 13353
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Düsseldorf, 40225
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Freiburg im Breisgau, 79106
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Hanover, 30625
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Homburg/saar, 66424
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Kiel, 24105
Italy6 sites
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Bergamo, 24128
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Bologna, 40138
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Milan, 20121
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Naples, 80131
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Pavia, 27100
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Pisa, 56124
Australia5 sites
Study site
Adelaide, 5000
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Brisbane, 4029
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Kingswood
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Melbourne, 3181
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Woolloongabba, 4102
Puerto Rico4 sites
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Ponce, 00716
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San Juan, 00921-3200
Study site
San Juan, 00936-5067
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Santurce, 00909
Canada3 sites
Study site
Downsview, Ontario, M3N 2V7
Study site
Edmonton, Alberta, T6G 2B7
Study site
Mississauga, Ontario, L5M 2V8
About this study
Official title: 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.
- Conditions
- Hepatitis C, Chronic
- Being tested
- Copegus, peginterferon alfa-2a [Pegasys]
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CopegusDrug
400mg po bid for 16 weeks
CopegusDrug
400mg po bid for 24 weeks
peginterferon alfa-2a [Pegasys]Drug
180 micrograms sc weekly for 16 weeks
peginterferon alfa-2a [Pegasys]Drug
180 micrograms sc weekly for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Copegus; Drug: peginterferon alfa-2a [Pegasys] |
| 2 | Experimental | Not described Receives: Drug: Copegus; Drug: peginterferon alfa-2a [Pegasys] |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Sustained Virological Response (SVR)
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.
Measured: Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)
Secondary outcomes (6)
Percentage of Participants With Virological Response at The End of Study Treatment
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.
Measured: Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)
Percentage of Participants Virological Response 12 Weeks Post-Treatment
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.
Measured: 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)
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.
Measured: Up to Week 40 and Week 48
Percentage of Participants With Marked Laboratory Abnormalities
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.
Measured: Up to Week 40 and Week 48
Participants With Marked Abnormal Vital Signs
Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.
Measured: Up to Week 40 and Week 48
Number of Participants With Highest Triglyceride Level
Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed.
Measured: Up to Week 40 and Week 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2004 (estimated)
- Study startDec 2003
- Primary completionMar 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077636
- Sponsor's protocol ID
- NV17317
- Status last verified
- Jan 2016
- First submitted
- 10 Feb 2004
- Last updated
- 23 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34. doi: 10.1056/NEJMoa066403.
PubMed 17625124
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00077636
- Acronym / sponsor ID
- NV17317
- Conditions
- Hepatitis C, Chronic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,469 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2003
- Primary completion
- Mar 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 13 Feb 2004 (estimated)
- Results
- Posted 21 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Copegus, Drug: peginterferon alfa-2a [Pegasys] |
| 2 | Experimental | Drug: Copegus, Drug: peginterferon alfa-2a [Pegasys] |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Copegus400mg po bid for 16 weeks | Drug | 1 |
| Copegus400mg po bid for 24 weeks | Drug | 2 |
| peginterferon alfa-2a [Pegasys]180 micrograms sc weekly for 16 weeks | Drug | 1 |
| peginterferon alfa-2a [Pegasys]180 micrograms sc weekly for 24 weeks | Drug | 2 |
Primary outcome
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.
6 secondary outcomes
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)
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)
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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 Marked Abnormal Vital Signs
Time frame: Up to Week 40 and Week 48
Number of Participants With Highest Triglyceride Level
Time frame: Up to Week 40 and Week 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 17625124Shiffman ML, Suter F, Bacon BR, Nelson D, Harley H, Sola R, Shafran SD, Barange K, Lin A, Soman A, Zeuzem S; ACCELERATE Investigators. Peginterferon alfa-2a and ribavirin for 16 or 24 weeks in HCV genotype 2 or 3. N Engl J Med. 2007 Jul 12;357(2):124-34. doi: 10.1056/NEJMoa066403.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
132 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Copegus and peginterferon alfa-2a [Pegasys] in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 132 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 132 sites in United States, Spain, France, Germany, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Sustained Virological Response (SVR) (time frame: Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00077636, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2016.