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.
Primary Purpose
Hepatitis C, Chronic
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Copegus
Copegus
peginterferon alfa-2a [Pegasys]
peginterferon alfa-2a [Pegasys]
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
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.
Participants With Marked Abnormal Vital Signs
Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.
Number of Participants With Highest Triglyceride Level
Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00077636
Brief Title
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.
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
December 2003 (undefined)
Primary Completion Date
March 2006 (Actual)
Study Completion Date
March 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief 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. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1469 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Copegus
Intervention Description
400mg po bid for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Copegus
Intervention Description
400mg po bid for 24 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 micrograms sc weekly for 16 weeks
Intervention Type
Drug
Intervention Name(s)
peginterferon alfa-2a [Pegasys]
Intervention Description
180 micrograms sc weekly for 24 weeks
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virological Response (SVR)
Description
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.
Time Frame
Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Virological Response at The End of Study Treatment
Description
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.
Time Frame
Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group)
Title
Percentage of Participants Virological Response 12 Weeks Post-Treatment
Description
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.
Time Frame
Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group)
Title
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to Week 40 and Week 48
Title
Percentage of Participants With Marked Laboratory Abnormalities
Description
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.
Time Frame
Up to Week 40 and Week 48
Title
Participants With Marked Abnormal Vital Signs
Description
Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs.
Time Frame
Up to Week 40 and Week 48
Title
Number of Participants With Highest Triglyceride Level
Description
Participants with triglyceride level above normal (i.e. < 200 mg/dL) were analysed.
Time Frame
Up to Week 40 and Week 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
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United States
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36693
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United States
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Anchorage
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Alaska
ZIP/Postal Code
99508
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United States
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Phoenix
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Arizona
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85006
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United States
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Scottsdale
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Arizona
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85259
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United States
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Little Rock
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Arkansas
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72205
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United States
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La Jolla
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California
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92037-1030
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United States
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Long Beach
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California
ZIP/Postal Code
90822
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United States
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Los Angeles
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California
ZIP/Postal Code
90048
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United States
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Palo Alto
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California
ZIP/Postal Code
94304-1509
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United States
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Sacramento
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California
ZIP/Postal Code
95825-2115
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United States
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San Diego
State/Province
California
ZIP/Postal Code
92105
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United States
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San Diego
State/Province
California
ZIP/Postal Code
92123
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United States
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San Diego
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California
ZIP/Postal Code
92154
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United States
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San Francisco
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California
ZIP/Postal Code
94115
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United States
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San Francisco
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California
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94121
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United States
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San Luis Obispo
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California
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93401
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United States
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Littleton
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Colorado
ZIP/Postal Code
80120
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United States
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Farmington
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Connecticut
ZIP/Postal Code
06030
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United States
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Bradenton
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Florida
ZIP/Postal Code
34209
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United States
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Gainesville
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Florida
ZIP/Postal Code
32610-0214
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United States
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Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
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United States
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Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
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United States
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Miami
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ZIP/Postal Code
33136
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United States
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Orlando
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Florida
ZIP/Postal Code
32803
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United States
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Pensacola
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Florida
ZIP/Postal Code
32514
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United States
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Tampa
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Florida
ZIP/Postal Code
33612
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United States
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Wellington
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Florida
ZIP/Postal Code
33414
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United States
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Atlanta
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Georgia
ZIP/Postal Code
30309
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United States
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Austell
State/Province
Georgia
ZIP/Postal Code
30106
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United States
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Honolulu
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Hawaii
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96817
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United States
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Boise
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Idaho
ZIP/Postal Code
83702
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United States
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Moline
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Illinois
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61265
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United States
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Indianapolis
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46202
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United States
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Iowa City
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Iowa
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52242
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United States
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Iowa City
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Iowa
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52246
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United States
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Baton Rouge
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70805
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United States
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New Orleans
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Louisiana
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70112
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United States
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Baltimore
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Maryland
ZIP/Postal Code
21201
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United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
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Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
City
Boston
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Massachusetts
ZIP/Postal Code
02720
Country
United States
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
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United States
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
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United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0362
Country
United States
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2689
Country
United States
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
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United States
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
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United States
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63104
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United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
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United States
City
Bayside
State/Province
New York
ZIP/Postal Code
11358
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United States
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Binghamton
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New York
ZIP/Postal Code
13903
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United States
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
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United States
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Manhasset
State/Province
New York
ZIP/Postal Code
11030
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United States
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
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United States
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Williamsville
State/Province
New York
ZIP/Postal Code
14221
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United States
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Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7584
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United States
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Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
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Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267-0595
Country
United States
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Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
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United States
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Portland
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Oregon
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97220
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United States
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Hershey
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Pennsylvania
ZIP/Postal Code
17033
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United States
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Lancaster
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Pennsylvania
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17604-3200
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United States
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Pittsburgh
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Pennsylvania
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15213
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United States
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Cranston
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Rhode Island
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02920
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United States
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02905
Country
United States
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235-9151
Country
United States
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234-3879
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
City
White River Junction
State/Province
Vermont
ZIP/Postal Code
05009-0001
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320-1706
Country
United States
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220-3649
Country
United States
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
City
Cheyenne
State/Province
Wyoming
ZIP/Postal Code
82001
Country
United States
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
City
Brisbane
ZIP/Postal Code
4029
Country
Australia
City
Kingswood
Country
Australia
City
Melbourne
ZIP/Postal Code
3181
Country
Australia
City
Woolloongabba
ZIP/Postal Code
4102
Country
Australia
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
City
Downsview
State/Province
Ontario
ZIP/Postal Code
M3N 2V7
Country
Canada
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
City
Clichy
ZIP/Postal Code
92118
Country
France
City
Creteil
ZIP/Postal Code
94010
Country
France
City
La Tronche
ZIP/Postal Code
38700
Country
France
City
Marseille
ZIP/Postal Code
13285
Country
France
City
Nice
ZIP/Postal Code
06202
Country
France
City
Rennes
ZIP/Postal Code
35033
Country
France
City
Strasbourg
ZIP/Postal Code
67091
Country
France
City
Toulouse
ZIP/Postal Code
31059
Country
France
City
Vandoeuvre-les-nancy
ZIP/Postal Code
54511
Country
France
City
Berlin
ZIP/Postal Code
13353
Country
Germany
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
City
Hannover
ZIP/Postal Code
30625
Country
Germany
City
Homburg/saar
ZIP/Postal Code
66424
Country
Germany
City
Kiel
ZIP/Postal Code
24105
Country
Germany
City
Bergamo
ZIP/Postal Code
24128
Country
Italy
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Milano
ZIP/Postal Code
20121
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Pisa
ZIP/Postal Code
56124
Country
Italy
City
Otahuhu
Country
New Zealand
City
Ponce
ZIP/Postal Code
00716
Country
Puerto Rico
City
San Juan
ZIP/Postal Code
00921-3200
Country
Puerto Rico
City
San Juan
ZIP/Postal Code
00936-5067
Country
Puerto Rico
City
Santurce
ZIP/Postal Code
00909
Country
Puerto Rico
City
Badalona
ZIP/Postal Code
08915
Country
Spain
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
City
Madrid
ZIP/Postal Code
08029
Country
Spain
City
Madrid
ZIP/Postal Code
28006
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Madrid
ZIP/Postal Code
28034
Country
Spain
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
City
Valencia
ZIP/Postal Code
46014
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
17625124
Citation
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.
Results Reference
derived
Learn more about this trial
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.
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