Trial · NCT00922779
A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C
NCT00922779, Phase 4, Completed, Hoffmann-La Roche; results first posted 2016-01-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C. Trials, record NCT00922779. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00922779
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Ribavirin in Combination With PEGASYS (Peginterferon Alfa-2a (40KD))in Patients With Chronic Hepatitis C
- NCT number
- NCT00922779
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 6,661 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Hepatitis C, Chronic
- Interventions
- peginterferon alfa-2a [Pegasys], ribavirin
- First posted
- 2009-06-17
- Last updated
- 2016-01-20
- Results first posted
- 2016-01-20
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 Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) | From signing of informed consent up to end of study (up to Week 72) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Number of participants with non-serious AEs were exclusive of serious AEs. |
| Secondary | Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy | 24 weeks after end of therapy (Week 72) | SVR at 24 weeks after end of therapy was defined as a negative result of HCV Ribonucleic Acid (HCV RNA) qualitative assay 24 weeks after end of therapy. Percentage of participants with SVR was calculated as \[number of participants with negative results of HCV RNA qualitative assay 24 weeks after end of therapy divided by the total number of participants analyzed\] multiplied by 100. The participants who failed to undergo tests at 24 weeks after completion of therapy were considered not amenable to therapy. |
| Secondary | Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation | Weeks 12,24 and 48 After Therapy Initiation | HCV RNA levels of \< 50 International Units per milliliter (IU/mL) were defined as undetectable HCV RNA. The percentage of participants with undetectable HCV RNA was calculated as \[number of participants with undetectable HCV RNA divided by the total number of participants analyzed\] multiplied by 100 for Weeks 12, 24 and 48. |
| Secondary | Percentage of Participants With Change in Hemoglobin Level | Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72) | Change in hemoglobin level (compared to baseline) was reported as "significant decrease", "Normal" (no change), "Increase", "Decrease", and "Missing". Significant decrease was defined as per Investigator's discretion. |
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 Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) | From signing of informed consent up to end of study (up to Week 72) | Safety analysis population included all participants who received at least one therapeutic dose of ribavirin. | Participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy | 24 weeks after end of therapy (Week 72) | Intent-to-treat (ITT) population included all participants who received at least one therapeutic dose of ribavirin. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation | Weeks 12,24 and 48 After Therapy Initiation | ITT Population. | Percentage of Participants | NUMBER |
| SECONDARY | Percentage of Participants With Change in Hemoglobin Level | Baseline, Weeks 2, 4, 8, 12, 24, 36, 48 and follow-up Weeks 4 (Week 52), 12 (Week 60), and 24 (Week 72) | ITT Population. | Percentage of Participants | NUMBER |
Source ClinicalTrials.gov
Results by group56
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 Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) | Ribavirin + Peginterferon Alfa-2a | Non Serious AEs | 2058 | Participants | |
| Number of Participants With Non-Serious Adverse Events (AEs) And Serious Adverse Events (SAEs) | Ribavirin + Peginterferon Alfa-2a | SAEs | 67 | Participants | |
| Percentage of Participants With Sustained Virological Response (SVR) at 24 Weeks After End of Therapy | Ribavirin + Peginterferon Alfa-2a | 50.9 | Percentage of Participants | ||
| Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation | Ribavirin + Peginterferon Alfa-2a | Week 12 | 58.8 | Percentage of Participants | |
| Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation | Ribavirin + Peginterferon Alfa-2a | Week 24 | 69.7 | Percentage of Participants | |
| Percentage of Participants With Undetectable HCV RNA at Weeks 12, 24 and 48 After Therapy Initiation | Ribavirin + Peginterferon Alfa-2a | Week 48 | 24.8 | Percentage of Participants | |
| Percentage of Participants With Change in Hemoglobin Level | Ribavirin + Peginterferon Alfa-2a | Week 2, Significant decrease | 13.5 | Percentage of Participants | |
| Percentage of Participants With Change in Hemoglobin Level | Ribavirin + Peginterferon Alfa-2a | Week 2, Normal | 32.4 | Percentage of Participants | |
| Percentage of Participants With Change in Hemoglobin Level | Ribavirin + Peginterferon Alfa-2a | Week 2, Increase | 11.7 | Percentage of Participants | |
| Percentage of Participants With Change in Hemoglobin Level | Ribavirin + Peginterferon Alfa-2a | Week 2, Decrease | 32.3 | Percentage of Participants |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ribavirin + Peginterferon Alfa-2a | 6,661 | |
| Overall Study | COMPLETED | Ribavirin + Peginterferon Alfa-2a | 4,334 | |
| Overall Study | NOT COMPLETED | Ribavirin + Peginterferon Alfa-2a | 2,327 |
Source ClinicalTrials.gov
Adverse events70
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 | Asthenia | General disorders | Ribavirin + Peginterferon Alfa-2a | 905 | 6,661 | |
| other | Influenza like illness | General disorders | Ribavirin + Peginterferon Alfa-2a | 833 | 6,661 | |
| other | Pyrexia | General disorders | Ribavirin + Peginterferon Alfa-2a | 371 | 6,661 | |
| other | Anaemia | Blood and lymphatic system disorders | Ribavirin + Peginterferon Alfa-2a | 459 | 6,661 | |
| other | Weight loss poor | Metabolism and nutrition disorders | Ribavirin + Peginterferon Alfa-2a | 343 | 6,661 | |
| serious | Pyelonephritis acute | Infections and infestations | Ribavirin + Peginterferon Alfa-2a | 2 | 6,661 | |
| serious | Acute tonsillitis | Infections and infestations | Ribavirin + Peginterferon Alfa-2a | 1 | 6,661 | |
| serious | Appendicitis | Infections and infestations | Ribavirin + Peginterferon Alfa-2a | 1 | 6,661 | |
| serious | Chronic hepatitis C | Infections and infestations | Ribavirin + Peginterferon Alfa-2a | 1 | 6,661 | |
| serious | Enteritis infectious | Infections and infestations | Ribavirin + Peginterferon Alfa-2a | 1 | 6,661 |
1 to 10 of 70Source ClinicalTrials.gov
See all 70 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ribavirin + Peginterferon Alfa-2a | ||
| Total, other adverse events | Ribavirin + Peginterferon Alfa-2a | 1,674 | 6,661 |
| Total, serious adverse events | Ribavirin + Peginterferon Alfa-2a | 67 | 6,661 |
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/NCT00922779
GET https://conductscience.org/api/trials/v1/NCT00922779/results?page=2