Trial · NCT00039871
PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)
NCT00039871, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2008-12-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370). Trials, record NCT00039871. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00039871
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)
- NCT number
- NCT00039871
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 2,333 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hepatitis, Hepatitis C, Chronic, Fibrosis, Liver Cirrhosis
- Interventions
- PegIntron (peginterferon alfa-2b; SCH 54031), REBETOL (ribavirin; SCH 18908)
- First posted
- 2002-06-14
- Last updated
- 2017-04-04
- Results first posted
- 2008-12-11
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sustained Virologic Response (SVR) Rate | Assessed at end of 24 weeks posttreatment follow-up | Number of participants with undetectable hepatitis C virus RNA (HCV-RNA) |
| Secondary | Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12 | 24 weeks posttreatment | Number of participants with undetectable HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up |
| Secondary | Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12 | 24 weeks posttreatment | Number of participants with detectable HCV-RNA but ≥2 log drop from baseline in HCV-RNA at Treatment Week 12 who had subsequent undetectable HCV-RNA after 24 weeks of posttreatment follow-up |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sustained Virologic Response (SVR) Rate | Assessed at end of 24 weeks posttreatment follow-up | Participants who received at least one dose of study medication | Participants | NUMBER |
| SECONDARY | Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12 | 24 weeks posttreatment | Participants who had undetectable HCV-RNA at Treatment Week 12 | Participants | NUMBER |
| SECONDARY | Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12 | 24 weeks posttreatment | Participants with detectable but \>=2 log drop in HCV-RNA at Treatment Week 12 | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sustained Virologic Response (SVR) Rate | PegIntron Plus Rebetol | 497 | Participants | ||
| Sustained Virologic Response (SVR) for Participants With Undetectable HCV-RNA at Treatment Week 12 | PegIntron Plus Rebetol | 463 | Participants | ||
| Sustained Virologic Response (SVR) for Participants With Detectable But ≥2 Log Drop in HCV-RNA at Treatment Week 12 | PegIntron Plus Rebetol | 23 | 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 Plus Rebetol | 2,312 | |
| Overall Study | COMPLETED | PegIntron Plus Rebetol | 928 | |
| Overall Study | NOT COMPLETED | PegIntron Plus Rebetol | 1,384 |
Source ClinicalTrials.gov
Adverse events273
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 | ANAEMIA | Blood and lymphatic system disorders | PegIntron Plus Rebetol | 372 | 2,312 | 721 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | PegIntron Plus Rebetol | 239 | 2,312 | 538 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | PegIntron Plus Rebetol | 455 | 2,312 | 1,271 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | PegIntron Plus Rebetol | 174 | 2,312 | 436 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | PegIntron Plus Rebetol | 155 | 2,312 | 206 |
| other | DIARRHOEA | Gastrointestinal disorders | PegIntron Plus Rebetol | 342 | 2,312 | 486 |
| other | DRY MOUTH | Gastrointestinal disorders | PegIntron Plus Rebetol | 145 | 2,312 | 155 |
| other | DYSPEPSIA | Gastrointestinal disorders | PegIntron Plus Rebetol | 129 | 2,312 | 150 |
| other | NAUSEA | Gastrointestinal disorders | PegIntron Plus Rebetol | 587 | 2,312 | 925 |
| other | VOMITING | Gastrointestinal disorders | PegIntron Plus Rebetol | 210 | 2,312 | 281 |
1 to 10 of 273Source ClinicalTrials.gov
See all 273 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PegIntron Plus Rebetol | ||
| Total, other adverse events | PegIntron Plus Rebetol | 2,201 | 2,312 |
| Total, serious adverse events | PegIntron Plus Rebetol | 200 | 2,312 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21056496 | RESULT |
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/NCT00039871
GET https://conductscience.org/api/trials/v1/NCT00039871/events?page=2