Trial · NCT00724893
Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)
NCT00724893, Completed, Merck Sharp & Dohme LLC; results first posted 2013-11-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423). Trials, record NCT00724893. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00724893
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Pegetron® Redipen™ Treatment and Treatment Compliance of Patients With Chronic Hepatitis C in Canada (P04423)
- NCT number
- NCT00724893
- Status
- Completed
- Enrollment
- 2,430 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Interventions
- PegIFN-2b, Ribavirin
- First posted
- 2008-07-30
- Last updated
- 2015-08-14
- Results first posted
- 2013-11-20
Source ClinicalTrials.gov
Registered outcomes52
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1) | Up to 72 weeks | This is a measure of the number of participants achieving a viral response (negative hepatitis C virus ribonucleic acid \[HCV-RNA\]) at either of the follow-up evaluation time points (12 weeks \[window 10-14 weeks\] or ≥22 weeks after the end of treatment (EOT). Participants with no viral response information were considered viral response "no". |
| Primary | Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1) | Up to 62 weeks | This is a measure of the number of participants achieving a viral response (negative HCV-RNA) at 12 weeks (window 10-14 weeks) after EOT. Participants with no viral response information were considered viral response "no". |
| Primary | Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1) | Up to 72 weeks | This is a measure of the number of participants who achieved SVR, defined as HCV-RNA negative at ≥22 weeks after EOT. Participants with no viral response information were considered viral response "no". |
| Primary | Number of Participants Achieving SVR (Stage 2) | Up to 72 weeks | SVR was defined as HCV-RNA negative at six months after EOT. Participants with no viral response information were considered viral response "no". |
| Secondary | Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2) | Up to 48 weeks | An adverse event is any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment |
| Secondary | Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1) | Up to 72 weeks | Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no". |
| Secondary | Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) | Up to 62 weeks | Viral response was defined as negative HCV-RNA. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no". |
| Secondary | Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no". |
| Secondary | The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1) | Up to 62 weeks | Viral response was defined as negative HCV-RNA; evaluation was done 12 weeks (window 10-14 weeks) after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no". |
| Secondary | The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1) | Up to 72 weeks | SVR was defined as HCV-RNA negative at ≥22 weeks after EOT. EVR was defined as either HCV-RNA detectable with a ≥2 log reduction from baseline or HCV-RNA negative at Treatment Week 12. Participants with no viral response information were considered viral response "no". |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 registered outcomesOutcomes52
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1) | Up to 72 weeks | All participants who took at least one dose of study medication (ITT Population) | participants | NUMBER |
| PRIMARY | Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1) | Up to 62 weeks | All participants who took at least one dose of study medication (ITT population) | Participants | NUMBER |
| PRIMARY | Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1) | Up to 72 weeks | All participants who took at least one dose of study medication (ITT population) | Participants | NUMBER |
| PRIMARY | Number of Participants Achieving SVR (Stage 2) | Up to 72 weeks | All participants who took at least one dose of study medication (ITT Population) | participants | NUMBER |
| SECONDARY | Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2) | Up to 48 weeks | All participants who took at least one dose of study medication (ITT Population) | participants | NUMBER |
| SECONDARY | Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1) | Up to 72 weeks | Participants in the ITT population with EVR evaluation at Treatment Week 12 | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) | Up to 62 weeks | Participants in the ITT population with EVR evaluation at Treatment Week 12 | Participants | NUMBER |
| SECONDARY | Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) | Up to 72 weeks | Participants in the ITT population with EVR evaluation at Treatment Week 12 | Participants | NUMBER |
| SECONDARY | The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1) | Up to 62 weeks | Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data | Participants | NUMBER |
| SECONDARY | The Number of Participants Achieving SVR Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1) | Up to 72 weeks | Participants in the ITT population with EVR evaluation at Treatment Week 12 and no missing data | participants | NUMBER |
1 to 10 of 52Source ClinicalTrials.gov
See all 52 outcomesResults by group240
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Achieving Viral Response at Any Evaluation Point (Stage 1) | Stage 1 Participants | 685 | participants | ||
| Number of Participants Achieving Viral Response at 12 Weeks After EOT (Stage 1) | Stage 1 Participants | 660 | Participants | ||
| Number of Participants Achieving Sustained Viral Response (SVR) (Stage 1) | Stage 1 Participants | 638 | Participants | ||
| Number of Participants Achieving SVR (Stage 2) | Stage 2 Participants | 468 | participants | ||
| Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2) | Stage 1 Participants | 76 | participants | ||
| Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2) | Stage 2 Participants | 142 | participants | ||
| Number of Participants Achieving Viral Response at Any Evaluation Point, Excluding Participants Who Discontinued Treatment Prior to Early Virologic Response (EVR) Evaluation (Stage 1) | Stage 1 Participants | 685 | Participants | ||
| Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) | Stage 1 Participants | 660 | Participants | ||
| Number of Participants Achieving SVR, Excluding Participants Who Discontinued Prior to EVR Evaluation (Stage 1) | Stage 1 Participants | 638 | Participants | ||
| The Number of Participants Achieving Viral Response at 12 Weeks After EOT, Excluding Participants Who Discontinued Prior to EVR Evaluation and Participants With Missing Data (Stage 1) | Stage 1 Participants | 679 | Participants |
1 to 10 of 240Source ClinicalTrials.gov
See all 240 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Stage 1 Participants | 1,302 | |
| Overall Study | STARTED | Stage 2 Participants | 1,128 | |
| Overall Study | COMPLETED | Stage 1 Participants | 938 | |
| Overall Study | COMPLETED | Stage 2 Participants | 670 | |
| Overall Study | NOT COMPLETED | Stage 1 Participants | 364 | |
| Overall Study | NOT COMPLETED | Stage 2 Participants | 458 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1 Participants | ||
| Total, all-cause mortality | Stage 2 Participants | ||
| Total, other adverse events | Stage 1 Participants | 0 | 0 |
| Total, other adverse events | Stage 2 Participants | 0 | 0 |
| Total, serious adverse events | Stage 1 Participants | 0 | 0 |
| Total, serious adverse events | Stage 2 Participants | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Stage 1 Participants vs Stage 2 Participants: Number of Participants Discontinued From Study Treatment Due to Adverse Events (Stage 1 and Stage 2) |
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/NCT00724893
GET https://conductscience.org/api/trials/v1/NCT00724893/registered?page=2