Trial · NCT00077636
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.
NCT00077636, Phase 4, Completed, Hoffmann-La Roche; results first posted 2016-01-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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. Trials, record NCT00077636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00077636
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- 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.
- NCT number
- NCT00077636
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,469 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Hepatitis C, Chronic
- Interventions
- Copegus, Copegus, peginterferon alfa-2a [Pegasys], peginterferon alfa-2a [Pegasys]
- First posted
- 2004-02-13
- Last updated
- 2016-02-23
- Results first posted
- 2016-01-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virological Response (SVR) | 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. |
| Secondary | Percentage of Participants With Virological Response at The End of Study Treatment | 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. |
| Secondary | Percentage of Participants Virological Response 12 Weeks Post-Treatment | 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. |
| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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. |
| Secondary | Percentage of Participants With Marked Laboratory Abnormalities | 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. |
| Secondary | Participants With Marked Abnormal Vital Signs | Up to Week 40 and Week 48 | Participants with changes in Systolic and diastolic blood pressure, heart rate were analysed abnormal vital signs. |
| Secondary | Number of Participants With Highest Triglyceride Level | Up to Week 40 and Week 48 | Participants with triglyceride level above normal (i.e. \< 200 mg/dL) were analysed. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Sustained Virological Response (SVR) | Week 40 (for 16-week treatment group); Week 48 (for 24-week treatment group) | Standard population: The standard population includes all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virological Response at The End of Study Treatment | Week 16 (for 16-week treatment group); Week 24 (for 24-week treatment group) | Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Virological Response 12 Weeks Post-Treatment | Week 28 (for 16-week treatment group); Week 36 (for 24-week treatment group) | Standard population: The standard population included all randomized participants who received at least one dose of study medication and who did not have any of the major protocol violations or deviations. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to Week 40 and Week 48 | Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Marked Laboratory Abnormalities | Up to Week 40 and Week 48 | Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment. | Percentage of participants | NUMBER |
| SECONDARY | Participants With Marked Abnormal Vital Signs | Up to Week 40 and Week 48 | Safety population: The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment. | participants | NUMBER |
| SECONDARY | Number of Participants With Highest Triglyceride Level | Up to Week 40 and Week 48 | The safety population includes all randomized patients who received at least one dose of either study drug and had at least one post baseline safety assessment. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group106
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Sustained Virological Response (SVR) | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | 65 | percentage of participants | ||
| Percentage of Participants With Sustained Virological Response (SVR) | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | 76 | percentage of participants | ||
| Percentage of Participants With Virological Response at The End of Study Treatment | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | 94 | Percentage of participants | ||
| Percentage of Participants With Virological Response at The End of Study Treatment | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | 92 | Percentage of participants | ||
| Percentage of Participants Virological Response 12 Weeks Post-Treatment | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | 59 | Percentage of participants | ||
| Percentage of Participants Virological Response 12 Weeks Post-Treatment | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | 69 | Percentage of participants | ||
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | Any AE | 97 | Percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | Any AE | 99 | Percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | Any SAE | 5 | Percentage of participants | |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | Any SAE | 6 | Percentage of participants |
1 to 10 of 106Source ClinicalTrials.gov
See all 106 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | 736 | |
| Overall Study | STARTED | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | 733 | |
| Overall Study | COMPLETED | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | 692 | |
| Overall Study | COMPLETED | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | 641 | |
| Overall Study | NOT COMPLETED | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | 44 | |
| Overall Study | NOT COMPLETED | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | 92 |
Source ClinicalTrials.gov
Adverse events224
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Vision blurred | Eye disorders | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | 37 | 731 | |
| other | Vision blurred | Eye disorders | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | 38 | 728 | |
| other | Abdominal pain | Gastrointestinal disorders | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | 36 | 731 | |
| other | Abdominal pain | Gastrointestinal disorders | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | 47 | 728 | |
| other | Abdominal pain upper | Gastrointestinal disorders | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | 43 | 731 | |
| other | Abdominal pain upper | Gastrointestinal disorders | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | 40 | 728 | |
| other | Diarrhoea | Gastrointestinal disorders | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | 123 | 731 | |
| other | Diarrhoea | Gastrointestinal disorders | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | 165 | 728 | |
| other | Dry mouth | Gastrointestinal disorders | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | 27 | 731 | |
| other | Dry mouth | Gastrointestinal disorders | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | 37 | 728 |
1 to 10 of 224Source ClinicalTrials.gov
See all 224 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | ||
| Total, all-cause mortality | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | ||
| Total, other adverse events | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | 696 | 731 |
| Total, other adverse events | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | 713 | 728 |
| Total, serious adverse events | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks | 34 | 731 |
| Total, serious adverse events | PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks | 47 | 728 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 17625124 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks vs PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00077636
GET https://conductscience.org/api/trials/v1/NCT00077636/results?page=2