Trial · NCT00727311
Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED)
NCT00727311, Completed, Merck Sharp & Dohme LLC; results first posted 2011-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED). Trials, record NCT00727311. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00727311
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real-life Surveillance Study of Patients With Chronic Hepatitis C Treated With PegIntron Injector and Rebetol (Study P04538)(COMPLETED)
- NCT number
- NCT00727311
- Status
- Completed
- Enrollment
- 2,302 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Interventions
- PegIntron (peginterferon alfa-2b; SCH 54031) injector, Rebetol (ribavirin; SCH 18908)
- First posted
- 2008-08-01
- Last updated
- 2015-10-09
- Results first posted
- 2011-01-10
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT) | 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6 | HCV-RNA level was measured by polymerase chain reaction (PCR). |
| Primary | Number of Participants With Early Virologic Response (EVR) | Treatment Week 12 | EVR was defined as at least a 2 log reduction in HCV-RNA or HCV-RNA negativity from baseline to Week 12 |
| Primary | Number of Participants With Sustained Virologic Response (SVR) | 24 weeks post-treatment (Week 48 or 72, depending on genotype) | SVR was defined as HCV-RNA negativity at EoT and at the follow-up 6 months after the EoT |
| Primary | Number of HCV-RNA Negative Participants at Follow-up | 24 weeks post-treatment (Weeks 48 or 72, depending on genotype) | HCV-RNA was measured by PCR. |
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 | Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT) | 24 weeks in genotypes 2 and 3, and 48 weeks in genotypes 1, 4, 5, and 6 | Number of evaluable participants at EoT | Participants | NUMBER |
| PRIMARY | Number of Participants With Early Virologic Response (EVR) | Treatment Week 12 | Number of evaluable participants at 12 weeks of treatment | Participants | NUMBER |
| PRIMARY | Number of Participants With Sustained Virologic Response (SVR) | 24 weeks post-treatment (Week 48 or 72, depending on genotype) | Number of evaluable participants with follow-up information | Participants | NUMBER |
| PRIMARY | Number of HCV-RNA Negative Participants at Follow-up | 24 weeks post-treatment (Weeks 48 or 72, depending on genotype) | Number of participants with results at the 6 month follow-up examination | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Negative Participants at End of Therapy (EoT) | PegIntron + Rebetol | 1306 | Participants | ||
| Number of Participants With Early Virologic Response (EVR) | PegIntron + Rebetol | 1168 | Participants | ||
| Number of Participants With Sustained Virologic Response (SVR) | PegIntron + Rebetol | 888 | Participants | ||
| Number of HCV-RNA Negative Participants at Follow-up | PegIntron + Rebetol | 887 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PegIntron + Rebetol | 2,302 | |
| Overall Study | COMPLETED | PegIntron + Rebetol | 1,195 | |
| Overall Study | NOT COMPLETED | PegIntron + Rebetol | 1,107 |
Source ClinicalTrials.gov
Adverse events60
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 | FATIGUE | General disorders | All Participants | 151 | 2,302 | 158 |
| serious | ANAEMIA | Blood and lymphatic system disorders | All Participants | 5 | 2,302 | 5 |
| serious | LEUKOPENIA | Blood and lymphatic system disorders | All Participants | 4 | 2,302 | 4 |
| serious | THROMBOCYTOPENIA | Blood and lymphatic system disorders | All Participants | 2 | 2,302 | 3 |
| serious | PALPITATIONS | Cardiac disorders | All Participants | 1 | 2,302 | 1 |
| serious | HYPERTHYROIDISM | Endocrine disorders | All Participants | 2 | 2,302 | 2 |
| serious | ABDOMINAL DISCOMFORT | Gastrointestinal disorders | All Participants | 1 | 2,302 | 1 |
| serious | ASCITES | Gastrointestinal disorders | All Participants | 2 | 2,302 | 2 |
| serious | DIARRHOEA | Gastrointestinal disorders | All Participants | 2 | 2,302 | 2 |
| serious | NAUSEA | Gastrointestinal disorders | All Participants | 5 | 2,302 | 5 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Participants | ||
| Total, other adverse events | All Participants | 151 | 2,302 |
| Total, serious adverse events | All Participants | 58 | 2,302 |
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 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/NCT00727311
GET https://conductscience.org/api/trials/v1/NCT00727311/events?page=2