Trial · NCT00394277
A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C
NCT00394277, Phase 4, Completed, Hoffmann-La Roche; results first posted 2010-07-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C. Trials, record NCT00394277. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00394277
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Induction Dosing With PEGASYS (Peginterferon Alfa-2a [40KD]) Plus Copegus in Treatment-Naive Patients With Chronic Hepatitis C
- NCT number
- NCT00394277
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,175 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Hepatitis C, Chronic
- Interventions
- peginterferon alfa-2a, Ribavirin, peginterferon alfa-2a, Ribavirin
- First posted
- 2006-10-31
- Last updated
- 2010-08-03
- Results first posted
- 2010-07-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sustained Virological Response (SVR)-24 (Scheduled Treatment Period) | Week 72 | SVR-24 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 24 weeks after completion of the treatment period (a single last HCV RNA PCR \<15 IU/mL measured at or after week 68 (ie, on or after study day 477). |
| Secondary | SVR-24 (Actual Treatment Period) | 24 weeks after end of treatment | SVR-24 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 20 weeks after the last dose of study drug. |
| Secondary | SVR-12 (Scheduled Treatment Period) | 12 weeks after end of treatment | SVR-12 according to the scheduled treatment period was defined as the percentage of patients with undetectable HCV RNA at 12 weeks after the scheduled treatment period (a single last HCV RNA PCR \<15 IU/mL measured at or after week 60). |
| Secondary | SVR-12 (Actual Treatment Period) | 12 weeks after end of treatment | SVR-12 according to the actual treatment period was defined as the percentage of patients with undetectable HCV RNA at least 12 weeks after the last dose of study drug. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sustained Virological Response (SVR)-24 (Scheduled Treatment Period) | Week 72 | Intent-to-treat population (all patients treated with at least one dose of either study medication) | Percentage of patients | NUMBER |
| SECONDARY | SVR-24 (Actual Treatment Period) | 24 weeks after end of treatment | Intent-to-treat population (all patients treated with at least one dose of either study medication) | Percentage of patients | NUMBER |
| SECONDARY | SVR-12 (Scheduled Treatment Period) | 12 weeks after end of treatment | Intent-to-treat population (all patients treated with at least one dose of either study medication) | Percentage of patients | NUMBER |
| SECONDARY | SVR-12 (Actual Treatment Period) | 12 weeks after end of treatment | Intent-to-treat population (all patients treated with at least one dose of either study medication) | Percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sustained Virological Response (SVR)-24 (Scheduled Treatment Period) | PEG-IFN 180 µg + Ribavirin 1200 mg | 37.7 | Percentage of patients | ||
| Sustained Virological Response (SVR)-24 (Scheduled Treatment Period) | PEG-IFN 180 µg + Ribavirin 1400/1600 mg | 42.9 | Percentage of patients | ||
| Sustained Virological Response (SVR)-24 (Scheduled Treatment Period) | PEG-IFN 360/180 µg + Ribavirin 1200 mg | 43.5 | Percentage of patients | ||
| Sustained Virological Response (SVR)-24 (Scheduled Treatment Period) | PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg | 40.7 | Percentage of patients | ||
| SVR-24 (Actual Treatment Period) | PEG-IFN 180 µg + Ribavirin 1200 mg | 38.2 | Percentage of patients | ||
| SVR-24 (Actual Treatment Period) | PEG-IFN 180 µg + Ribavirin 1400/1600 mg | 43.9 | Percentage of patients | ||
| SVR-24 (Actual Treatment Period) | PEG-IFN 360/180 µg + Ribavirin 1200 mg | 43.5 | Percentage of patients | ||
| SVR-24 (Actual Treatment Period) | PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg | 40.7 | Percentage of patients | ||
| SVR-12 (Scheduled Treatment Period) | PEG-IFN 180 µg + Ribavirin 1200 mg | 40.3 | Percentage of patients | ||
| SVR-12 (Scheduled Treatment Period) | PEG-IFN 180 µg + Ribavirin 1400/1600 mg | 45.0 | Percentage of patients |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PEG-IFN 180 µg + Ribavirin 1200 mg | 195 | |
| Overall Study | STARTED | PEG-IFN 180 µg + Ribavirin 1400/1600 mg | 196 | |
| Overall Study | STARTED | PEG-IFN 360/180 µg + Ribavirin 1200 mg | 393 | |
| Overall Study | STARTED | PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg | 391 | |
| Overall Study | COMPLETED | PEG-IFN 180 µg + Ribavirin 1200 mg | 137 | |
| Overall Study | COMPLETED | PEG-IFN 180 µg + Ribavirin 1400/1600 mg | 136 | |
| Overall Study | COMPLETED | PEG-IFN 360/180 µg + Ribavirin 1200 mg | 273 | |
| Overall Study | COMPLETED | PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg | 266 | |
| Overall Study | NOT COMPLETED | PEG-IFN 180 µg + Ribavirin 1200 mg | 58 | |
| Overall Study | NOT COMPLETED | PEG-IFN 180 µg + Ribavirin 1400/1600 mg | 60 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events588
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 | Pyrexia | General disorders | PEG-IFN 180 µg + Ribavirin 1200 mg | 83 | 191 | |
| other | Pyrexia | General disorders | PEG-IFN 180 µg + Ribavirin 1400/1600 mg | 78 | 189 | |
| other | Pyrexia | General disorders | PEG-IFN 360/180 µg + Ribavirin 1200 mg | 176 | 382 | |
| other | Pyrexia | General disorders | PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg | 205 | 383 | |
| other | Fatigue | General disorders | PEG-IFN 180 µg + Ribavirin 1200 mg | 66 | 191 | |
| other | Fatigue | General disorders | PEG-IFN 180 µg + Ribavirin 1400/1600 mg | 102 | 189 | |
| other | Fatigue | General disorders | PEG-IFN 360/180 µg + Ribavirin 1200 mg | 184 | 382 | |
| other | Fatigue | General disorders | PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg | 182 | 383 | |
| other | Chills | General disorders | PEG-IFN 180 µg + Ribavirin 1200 mg | 42 | 191 | |
| other | Chills | General disorders | PEG-IFN 180 µg + Ribavirin 1400/1600 mg | 55 | 189 |
1 to 10 of 588Source ClinicalTrials.gov
See all 588 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PEG-IFN 180 µg + Ribavirin 1200 mg | ||
| Total, all-cause mortality | PEG-IFN 180 µg + Ribavirin 1400/1600 mg | ||
| Total, all-cause mortality | PEG-IFN 360/180 µg + Ribavirin 1200 mg | ||
| Total, all-cause mortality | PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg | ||
| Total, other adverse events | PEG-IFN 180 µg + Ribavirin 1200 mg | 186 | 191 |
| Total, other adverse events | PEG-IFN 180 µg + Ribavirin 1400/1600 mg | 179 | 189 |
| Total, other adverse events | PEG-IFN 360/180 µg + Ribavirin 1200 mg | 370 | 382 |
| Total, other adverse events | PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg | 373 | 383 |
| Total, serious adverse events | PEG-IFN 180 µg + Ribavirin 1200 mg | 22 | 191 |
| Total, serious adverse events | PEG-IFN 180 µg + Ribavirin 1400/1600 mg | 20 | 189 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20816836 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00394277
GET https://conductscience.org/api/trials/v1/NCT00394277/events?page=2