Trial · NCT02557646
An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C
NCT02557646, Completed, Hoffmann-La Roche; results first posted 2016-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C. Trials, record NCT02557646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02557646
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study to Assess the Effect of Cumulative Ribavirin Dose in Participants With Chronic Hepatitis C
- NCT number
- NCT02557646
- Status
- Completed
- Enrollment
- 697 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Hepatitis C, Chronic
- Interventions
- Peginterferon alfa-2a, Ribavirin
- First posted
- 2015-09-23
- Last updated
- 2016-03-28
- Results first posted
- 2016-02-10
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin | 24 weeks after EOT (maximum up to 96 Weeks) | Determination of hepatitis C virus (HCV) titers was performed using COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C, at Weeks 4, 12 and 24 of the treatment period (and, optionally, at the end of treatment \[EOT\] visit), and at the end of the 24-week follow-up period. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. |
| Secondary | Percentage of Participants With Virologic Response | Week 4, 12, 24 and at EOT (maximum up to 72 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. |
| Secondary | Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin | Up to EOT (maximum up to 72 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose group is presented. |
| Secondary | Percentage of Participants With SVR According to Starting Dose of Ribavirin | 24 weeks after EOT (maximum up to 96 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose group is presented. |
| Secondary | Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin | Up to EOT (maximum up to 72 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each body weight-normalized (measured in milligram per kilogram per day \[mg/kg/day\]) dose group is presented. |
| Secondary | Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin | 24 weeks after EOT (maximum up to 96 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each body weight-normalized dose group is presented. |
| Secondary | Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin | Up to EOT (maximum up to 72 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24, and at EOT were interpreted as virological response. Percentage of participants achieving virological response in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented. |
| Secondary | Percentage of Participants With SVR According to Dose Reduction of Ribavirin | 24 weeks after EOT (maximum up to 96 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented. |
| Secondary | Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism | Up to EOT (maximum up to 72 weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response. Percentage of participants achieving virological response for each IL-28B allele (CC allele, CT allele, TT allele) is presented. |
| Secondary | Percentage of Participants With SVR According to IL-28B Polymorphism | 24 weeks after EOT (maximum up to 96 Weeks) | Determination of HCV titers was performed by using the COBAS AmpliPrep/COBAS TaqMan HCV technique, upon decision of the treating physician and respecting the therapeutic protocol for the treatment of hepatitis C. Negative HCV titers measured at Weeks 4, 12, 24 and at EOT were interpreted as virological response, and negative HCV titers measured at the end of the 24-week follow-up period were interpreted as SVR. Percentage of participants achieving SVR for each IL-28B allele (CC allele, CT allele, TT allele) is presented. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin | 24 weeks after EOT (maximum up to 96 Weeks) | ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virologic Response | Week 4, 12, 24 and at EOT (maximum up to 72 weeks) | ITT Population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin | Up to EOT (maximum up to 72 weeks) | ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With SVR According to Starting Dose of Ribavirin | 24 weeks after EOT (maximum up to 96 weeks) | ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virologic Response According to Body Weight-normalized Dose of Ribavirin | Up to EOT (maximum up to 72 weeks) | ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With SVR According to Body Weight-normalized Dose of Ribavirin | 24 weeks after EOT (maximum up to 96 weeks) | ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virologic Response According to Dose Reduction of Ribavirin | Up to EOT (maximum up to 72 weeks) | ITT Population. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With SVR According to Dose Reduction of Ribavirin | 24 weeks after EOT (maximum up to 96 weeks) | ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Virologic Response According to Interleukin-28B (IL-28B) Polymorphism | Up to EOT (maximum up to 72 weeks) | ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With SVR According to IL-28B Polymorphism | 24 weeks after EOT (maximum up to 96 Weeks) | ITT Population. Here, 'N' (number of participants analyzed) signifies the number of participants analyzed for this outcome measure and 'n' signifies the number of participants analyzed for specified category. | percentage of participants | NUMBER |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group107
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin | Peginterferon Alfa-2a + Ribavirin | Cumulative dose of ribavirin <60% (n=35) | 54.29 | percentage of participants | |
| Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin | Peginterferon Alfa-2a + Ribavirin | Cumulative dose of ribavirin = 60-69% (n=23) | 60.87 | percentage of participants | |
| Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin | Peginterferon Alfa-2a + Ribavirin | Cumulative dose of ribavirin = 70-79% (n=32) | 53.13 | percentage of participants | |
| Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin | Peginterferon Alfa-2a + Ribavirin | Cumulative dose of ribavirin = 80-89% (n=52) | 50.00 | percentage of participants | |
| Percentage of Participants Achieving Sustained Virological Response (SVR) According to Cumulative Dose of Ribavirin | Peginterferon Alfa-2a + Ribavirin | Cumulative dose of ribavirin >90% (n=264) | 68.56 | percentage of participants | |
| Percentage of Participants With Virologic Response | Peginterferon Alfa-2a + Ribavirin | Week 4 | 18.7 | percentage of participants | |
| Percentage of Participants With Virologic Response | Peginterferon Alfa-2a + Ribavirin | Week 12 | 32.7 | percentage of participants | |
| Percentage of Participants With Virologic Response | Peginterferon Alfa-2a + Ribavirin | Week 24 | 14.8 | percentage of participants | |
| Percentage of Participants With Virologic Response | Peginterferon Alfa-2a + Ribavirin | EOT | 1.8 | percentage of participants | |
| Percentage of Participants With Virologic Response According to Starting Dose of Ribavirin | Peginterferon Alfa-2a + Ribavirin | Starting dose of ribavirin = 200mg (n=1) | 0.00 | percentage of participants |
1 to 10 of 107Source ClinicalTrials.gov
See all 107 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Peginterferon Alfa-2a + Ribavirin | 693 | |
| Overall Study | COMPLETED | Peginterferon Alfa-2a + Ribavirin | 417 | |
| Overall Study | NOT COMPLETED | Peginterferon Alfa-2a + Ribavirin | 276 |
Source ClinicalTrials.gov
Adverse events53
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 | Peginterferon Alfa-2a + Ribavirin | 103 | 697 | |
| other | Leukopenia | Blood and lymphatic system disorders | Peginterferon Alfa-2a + Ribavirin | 39 | 697 | |
| other | Neutropenia | Blood and lymphatic system disorders | Peginterferon Alfa-2a + Ribavirin | 37 | 697 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Peginterferon Alfa-2a + Ribavirin | 40 | 697 | |
| other | Asthenia | General disorders | Peginterferon Alfa-2a + Ribavirin | 51 | 697 | |
| other | Fatigue | General disorders | Peginterferon Alfa-2a + Ribavirin | 91 | 697 | |
| other | Influenza like illness | General disorders | Peginterferon Alfa-2a + Ribavirin | 65 | 697 | |
| other | Pyrexia | General disorders | Peginterferon Alfa-2a + Ribavirin | 49 | 697 | |
| other | Decreased appetite | Metabolism and nutrition disorders | Peginterferon Alfa-2a + Ribavirin | 35 | 697 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Peginterferon Alfa-2a + Ribavirin | 49 | 697 |
1 to 10 of 53Source ClinicalTrials.gov
See all 53 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Peginterferon Alfa-2a + Ribavirin | ||
| Total, other adverse events | Peginterferon Alfa-2a + Ribavirin | 353 | 697 |
| Total, serious adverse events | Peginterferon Alfa-2a + Ribavirin | 52 | 697 |
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.
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