Trial · NCT00048724
Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)
NCT00048724, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-06-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569). Trials, record NCT00048724. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00048724
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Peg-Intron for Prevention of Disease Progress in Chronic Hepatitis C Patients With Cirrhosis (Study P02569)
- NCT number
- NCT00048724
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 631 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Chronic Hepatitis C, Cirrhosis
- Interventions
- peginterferon alfa-2b (SCH 54031)
- First posted
- 2002-11-08
- Last updated
- 2017-04-04
- Results first posted
- 2009-06-11
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Observation of the First Clinical Event Experienced by a Subject | Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event | Clinical events are liver decompensation \[variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites\], hepatic carcinoma, death, and/or liver transplantation |
| Secondary | Time to Observation of the Disease Progression Experienced by a Subject | Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event | Disease progression was observation of any clinical event defined for the primary outcome, plus any of development of Child-Pugh Class B, emergence of varices, or enlargement of pre-existing varices requiring additional therapy. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Observation of the First Clinical Event Experienced by a Subject | Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event | Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses. | Participants | NUMBER |
| SECONDARY | Time to Observation of the Disease Progression Experienced by a Subject | Up to 60 months of treatment or observation, or when 98 subjects experience at least one clinical event | Analysis population is modified intent to treat (MITT), comprising all randomized subjects from sites compliant with GCP (Good Clinical Practice). Two sites were closed due to GCP noncompliance, and the 5 subjects from these sites were excluded from efficacy analyses. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group44
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Observation of the First Clinical Event Experienced by a Subject | PegIntron | <=6 Months | 3 | Participants | |
| Time to Observation of the First Clinical Event Experienced by a Subject | Untreated Control | <=6 Months | 2 | Participants | |
| Time to Observation of the First Clinical Event Experienced by a Subject | PegIntron | >6 to 12 Months | 5 | Participants | |
| Time to Observation of the First Clinical Event Experienced by a Subject | Untreated Control | >6 to 12 Months | 5 | Participants | |
| Time to Observation of the First Clinical Event Experienced by a Subject | PegIntron | >12 to 18 Months | 4 | Participants | |
| Time to Observation of the First Clinical Event Experienced by a Subject | Untreated Control | >12 to 18 Months | 4 | Participants | |
| Time to Observation of the First Clinical Event Experienced by a Subject | PegIntron | >18 to 24 Months | 3 | Participants | |
| Time to Observation of the First Clinical Event Experienced by a Subject | Untreated Control | >18 to 24 Months | 7 | Participants | |
| Time to Observation of the First Clinical Event Experienced by a Subject | PegIntron | >24 to 30 Months | 7 | Participants | |
| Time to Observation of the First Clinical Event Experienced by a Subject | Untreated Control | >24 to 30 Months | 6 | Participants |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | PegIntron | 311 | |
| Overall Study | STARTED | Untreated Control | 315 | |
| Overall Study | COMPLETED | PegIntron | 195 | |
| Overall Study | COMPLETED | Untreated Control | 197 | |
| Overall Study | NOT COMPLETED | PegIntron | 116 | |
| Overall Study | NOT COMPLETED | Untreated Control | 118 |
Source ClinicalTrials.gov
Adverse events516
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 | LEUKOPENIA | Blood and lymphatic system disorders | PegIntron | 20 | 311 | 31 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Untreated Control | 8 | 315 | 9 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | PegIntron | 43 | 311 | 119 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Untreated Control | 18 | 315 | 26 |
| other | SPLENOMEGALY | Blood and lymphatic system disorders | PegIntron | 60 | 311 | 69 |
| other | SPLENOMEGALY | Blood and lymphatic system disorders | Untreated Control | 54 | 315 | 61 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | PegIntron | 52 | 311 | 122 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Untreated Control | 20 | 315 | 41 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | PegIntron | 33 | 311 | 40 |
| other | ABDOMINAL PAIN | Gastrointestinal disorders | Untreated Control | 21 | 315 | 27 |
1 to 10 of 516Source ClinicalTrials.gov
See all 516 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | PegIntron | ||
| Total, all-cause mortality | Untreated Control | ||
| Total, other adverse events | PegIntron | 290 | 311 |
| Total, other adverse events | Untreated Control | 260 | 315 |
| Total, serious adverse events | PegIntron | 93 | 311 |
| Total, serious adverse events | Untreated Control | 74 | 315 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21419770 | 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 |
|---|
| PegIntron vs Untreated Control: 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/NCT00048724
GET https://conductscience.org/api/trials/v1/NCT00048724/results?page=2