Trial · NCT00724854
Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427)
NCT00724854, Completed, Merck Sharp & Dohme LLC; results first posted 2011-01-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427). Trials, record NCT00724854. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00724854
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427)
- NCT number
- NCT00724854
- Status
- Completed
- Enrollment
- 1,146 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Interventions
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- First posted
- 2008-07-30
- Last updated
- 2015-02-25
- Results first posted
- 2011-01-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment | Assessed at Treatment Week 4 | Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment. |
| Secondary | Number of Participants Who Achieved Sustained Virologic Response (SVR) | Assessed at 24 weeks post-treatment | SVR was defined as non-detectable HCV RNA 24 weeks post-treatment. |
| Secondary | Number of Participants With RVR Who Also Achieved SVR | Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR) | RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment. |
| Secondary | Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR | Treatment Week 48 and Treatment Week 72 | Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5. |
| Secondary | Assessment of Baseline Characteristics in Participants With SVR | 24 Weeks post-treatment | Baseline characteristics assessed were age, gender, and genotype. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment | Assessed at Treatment Week 4 | Participants | NUMBER | |
| SECONDARY | Number of Participants Who Achieved Sustained Virologic Response (SVR) | Assessed at 24 weeks post-treatment | Participants | NUMBER | |
| SECONDARY | Number of Participants With RVR Who Also Achieved SVR | Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR) | Participants who achieved RVR at Treatment Week 4. | Participants | NUMBER |
| SECONDARY | Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR | Treatment Week 48 and Treatment Week 72 | Participants who achieved RVR at Treatment Week 4. | Participants | NUMBER |
| SECONDARY | Assessment of Baseline Characteristics in Participants With SVR | 24 Weeks post-treatment | Participants with SVR | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment | Mono-infected With HCV | 551 | Participants | ||
| Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment | Co-infected With HCV and HIV | 32 | Participants | ||
| Number of Participants Who Achieved Sustained Virologic Response (SVR) | Mono-infected With HCV | 375 | Participants | ||
| Number of Participants Who Achieved Sustained Virologic Response (SVR) | Co-infected With HCV and HIV | 24 | Participants | ||
| Number of Participants With RVR Who Also Achieved SVR | Mono-infected With HCV | 300 | Participants | ||
| Number of Participants With RVR Who Also Achieved SVR | Co-infected With HCV and HIV | 19 | Participants | ||
| Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR | Mono-infected With HCV | No SVR | 251 | Participants | |
| Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR | Co-infected With HCV and HIV | No SVR | 13 | Participants | |
| Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR | Mono-infected With HCV | SVR | 300 | Participants | |
| Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR | Co-infected With HCV and HIV | SVR | 19 | Participants |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Mono-infected With HCV | 1,010 | |
| Overall Study | STARTED | Co-infected With HCV and HIV | 72 | |
| Overall Study | COMPLETED | Mono-infected With HCV | 607 | |
| Overall Study | COMPLETED | Co-infected With HCV and HIV | 41 | |
| Overall Study | NOT COMPLETED | Mono-infected With HCV | 403 | |
| Overall Study | NOT COMPLETED | Co-infected With HCV and HIV | 31 |
Source ClinicalTrials.gov
Adverse events288
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 | Mono-Infected With HCV | 165 | 1,010 | 171 |
| other | ANAEMIA | Blood and lymphatic system disorders | Co-Infected With HCV and HIV | 18 | 72 | 19 |
| other | ANAEMIA | Blood and lymphatic system disorders | Not Evaluated | 5 | 64 | 6 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Mono-Infected With HCV | 38 | 1,010 | 39 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Co-Infected With HCV and HIV | 6 | 72 | 6 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Not Evaluated | 1 | 64 | 1 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Mono-Infected With HCV | 59 | 1,010 | 60 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Co-Infected With HCV and HIV | 7 | 72 | 9 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Not Evaluated | 5 | 64 | 5 |
| other | THROMBOCYTOPENIA | Blood and lymphatic system disorders | Mono-Infected With HCV | 34 | 1,010 | 34 |
1 to 10 of 288Source ClinicalTrials.gov
See all 288 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Mono-Infected With HCV | ||
| Total, all-cause mortality | Co-Infected With HCV and HIV | ||
| Total, all-cause mortality | Not Evaluated | ||
| Total, other adverse events | Mono-Infected With HCV | 762 | 1,010 |
| Total, other adverse events | Co-Infected With HCV and HIV | 61 | 72 |
| Total, other adverse events | Not Evaluated | 42 | 64 |
| Total, serious adverse events | Mono-Infected With HCV | 52 | 1,010 |
| Total, serious adverse events | Co-Infected With HCV and HIV | 0 | 72 |
| Total, serious adverse events | Not Evaluated | 8 | 64 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21871496 | 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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Mono-infected With HCV vs Co-infected With HCV and HIV: Number of Participants With RVR Who Also Achieved SVR | Trial comparisons |
| Mono-infected With HCV vs Co-infected With HCV and HIV: Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment | Trial comparisons |
| Mono-infected With HCV vs Co-infected With HCV and HIV: Number of Participants Who Achieved Sustained Virologic Response (SVR) | 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/NCT00724854
GET https://conductscience.org/api/trials/v1/NCT00724854/results?page=2