Trial · NCT01429792
A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
NCT01429792, Phase 4, Completed, Hoffmann-La Roche; results first posted 2018-10-23
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin). Trials, record NCT01429792. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01429792
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study Evaluating Slow Response/Non-Rapid Response in Patients With Chronic Hepatitis C, Genotype 1, 2, 3 & 4 Treated With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)
- NCT number
- NCT01429792
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,013 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Hepatitis C, Chronic
- Interventions
- peginterferon alfa-2a [Pegasys], ribavirin [Copegus]
- First posted
- 2011-09-07
- Last updated
- 2018-10-23
- Results first posted
- 2018-10-23
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment | Week 12 | The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12. |
| Primary | Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment | Week 12 | The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment |
| Primary | Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24 | Week 24 | The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment |
| Primary | Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | Week 4 | The rate of participants with RVR was defined as negative HCV-RNA level at Week 4 of study treatment. |
| Primary | Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment | Week 4 | The rate of participants without a RVR (non-RVR) was defined as detectible HCV-RNA level at Week 4 of standard treatment. |
| Primary | Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24 | Week 24 | The rate of participants with non-RVR and undetectable HCV-RNA at Week 24 was defined as detectable HCV-RNA level at Week 4 of study treatment and undetectable HCV-RNA at Week 24 of study. |
| Secondary | Percentage of Participants With pEVR to Study Treatment at Week 12 | Week 12 | The rate of participants with pEVR to study treatment was defined as ≥ 2 log reduction in HCV-RNA level from baseline value to Week 12 of study treatment but with detectable HCV-RNA at Week 12. |
| Secondary | Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment | Week 12 | The rate of participants with a cEVR to study treatment was defined as negative HCV-RNA level at Week 12 of study treatment. |
| Secondary | Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24 | Week 24 | The rate of participants with undetectable HCV-RNA at ETR at Week 24 was defined as at least a 2-log decrement in HCV-RNA from the start of treatment, but with detectable HCV-RNA at Week 12 of study treatment and undetectable HCV-RNA at Week 24 of study treatment. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment | Week 12 | Participants with CHC Genotype 1 \& 4 at week 12 | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment | Week 12 | Participants with CHC Genotype 1 \& 4 at Week 12 | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24 | Week 24 | Participants with CHC Genotype 1 \& 4 at Week 24 | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | Week 4 | Participants with CHC Genotype 2 \& 3 at Week 4 | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment | Week 4 | Participants with CHC Genotype 2 \& 3 at Week 4 | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24 | Week 24 | Participants with CHC Genotype 2 \& 3 at Week 24 | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With pEVR to Study Treatment at Week 12 | Week 12 | As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4. | ||
| SECONDARY | Percentge of Participants With a cEVR to Study Treatmen at Week 12 of Study Treatment | Week 12 | As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4. | ||
| SECONDARY | Percentage of Participants With Undetectable HCV-RNA at Week 24, But With Detectable HCV-RNA atWeek 12 and Undetectable HCV-RNA at Week 24 | Week 24 | As pre-specified in the protocol, genotypes 1 and 4 were combined due to insufficient enrollment for genotype 4. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Partial Early Virological Response (pEVR) to Study Treatment | Pegylated Interferon Alfa 2a (Peginterferon) | 15.7 | 95% Confidence Interval 12.6 to 18.1 | Percentage of participants | |
| Percentage of Participants With Complete Early Virologic Response (cEVR) to Study Treatment | Pegylated Interferon Alfa 2a (Peginterferon) | 50.8 | 95% Confidence Interval 46.8 to 54.4 | Percentage of participants | |
| Percentage of Participants With Undetectable HCV-RNA at End of Treatment Response (ETR) at Week 24 | Pegylated Interferon Alfa 2a (Peginterferon) | 15.6 | 95% Confidence Interval 12.9 to 19.2 | Percentage of participants | |
| Percentage of Participants With Rapid Virologic Response (RVR) at Week 4 | Pegylated Interferon Alfa 2a (Peginterferon) | 48.03 | 95% Confidence Interval 42.3 to 53.6 | Percentage of participants | |
| Percentage of Participants Without a RVR (Non-RVR) at Week 4 of Standard Treatment | Pegylated Interferon Alfa 2a (Peginterferon) | 51.97 | 95% Confidence Interval 46.2 to 57.6 | Percentage of participants | |
| Percentage of Participants With Non-RVR and Undetectable HCV-RNA at Week 24 | Pegylated Interferon Alfa 2a (Peginterferon) | 6.9 | 95% Confidence Interval 4.3 to 10.3 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Pegylated Interferon Alfa 2a (Peginterferon) | 1,013 | |
| Overall Study | Genotype 1 | Pegylated Interferon Alfa 2a (Peginterferon) | 687 | |
| Overall Study | Genotype 2 & 3 | Pegylated Interferon Alfa 2a (Peginterferon) | 305 | |
| Overall Study | Genotype 4 | Pegylated Interferon Alfa 2a (Peginterferon) | 5 | |
| Overall Study | COMPLETED | Pegylated Interferon Alfa 2a (Peginterferon) | 607 | |
| Overall Study | NOT COMPLETED | Pegylated Interferon Alfa 2a (Peginterferon) | 406 |
Source ClinicalTrials.gov
Adverse events51
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 | Anemia | Blood and lymphatic system disorders | Pegylated Interferon Alfa 2a (Peginterferon) | 103 | 1,013 | |
| other | Neutropenia | Blood and lymphatic system disorders | Pegylated Interferon Alfa 2a (Peginterferon) | 57 | 1,013 | |
| other | Asthenia | General disorders | Pegylated Interferon Alfa 2a (Peginterferon) | 103 | 1,013 | |
| serious | Anemia | Blood and lymphatic system disorders | Pegylated Interferon Alfa 2a (Peginterferon) | 8 | 1,013 | |
| serious | Haemolytic anemia | Blood and lymphatic system disorders | Pegylated Interferon Alfa 2a (Peginterferon) | 1 | 1,013 | |
| serious | Neutropenic fever | Blood and lymphatic system disorders | Pegylated Interferon Alfa 2a (Peginterferon) | 1 | 1,013 | |
| serious | Pancytopenia | Blood and lymphatic system disorders | Pegylated Interferon Alfa 2a (Peginterferon) | 3 | 1,013 | |
| serious | Acute myocardial infarction | Cardiac disorders | Pegylated Interferon Alfa 2a (Peginterferon) | 2 | 1,013 | |
| serious | Atrial fibrillation | Cardiac disorders | Pegylated Interferon Alfa 2a (Peginterferon) | 1 | 1,013 | |
| serious | Optic nerve disorder | Eye disorders | Pegylated Interferon Alfa 2a (Peginterferon) | 1 | 1,013 |
1 to 10 of 51Source ClinicalTrials.gov
See all 51 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Pegylated Interferon Alfa 2a (Peginterferon) | ||
| Total, other adverse events | Pegylated Interferon Alfa 2a (Peginterferon) | 131 | 1,013 |
| Total, serious adverse events | Pegylated Interferon Alfa 2a (Peginterferon) | 50 | 1,013 |
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/NCT01429792
GET https://conductscience.org/api/trials/v1/NCT01429792/events?page=2