Trial · NCT01447446
An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
NCT01447446, Completed, Hoffmann-La Roche; results first posted 2017-03-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C. Trials, record NCT01447446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01447446
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Observational Study on Dual And Triple Therapies Based on Peginterferon Alfa (e.g. Pegasys) in Patients With Chronic Hepatitis C
- NCT number
- NCT01447446
- Status
- Completed
- Enrollment
- 4,442 participants, actual
- Lead sponsor
- Hoffmann-La Roche
- Conditions
- Hepatitis C, Chronic
- Interventions
- Peg-IFN Alfa-2a, Peg-IFN Alfa-2b, Ribavirin, Boceprevir, Telaprevir
- First posted
- 2011-10-06
- Last updated
- 2017-03-30
- Results first posted
- 2017-03-30
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) | 24 weeks after end of treatment (up to 118 weeks) | SVR24 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to \[\<=\] 50 IU/mL) at 24 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be \<=50 IU/mL. SVR24 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection \<= 50 IU/mL at 24 weeks post completion of the treatment period. |
| Primary | Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) | 12 weeks after end of treatment (up to 118 weeks) | SVR12 rate for dual therapy participants is defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to \[\<=\] 50 IU/mL) at 12 weeks post completion of the treatment period. If a quantitative test was used, the lower limit of quantification had to be \<=50 IU/mL. SVR12 for triple therapy participants is defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection \<= 50 IU/mL at 12 weeks post completion of the treatment period. |
| Secondary | Virological Response at Various on Treatment Time Points and End of Treatment (EOT) | Week 4, 12 and End of treatment (EOT) (up to 96 weeks) | Virological response (VR) for dual therapy participants is defined as HCV RNA \<50 IU/mL as assessed by a qualitative HCV RNA test with a lower limit of detection (LLD) \<=50 IU/mL or as assessed by a quantitative test with a lower limit of quantification (LLQ) \<=50 IU/mL for all time points concerned. Results of HCV RNA tests with LLD and LLQ \>50 IU/mL were considered as non-response. VR for triple therapy participants is defined as undetectable HCV RNA assessed by a test with lower limit of detection \<=50 IU/mL (UVR). Results of HCV RNA tests with an LLD \>50 IU/mL were considered as non-response for triple therapy participants. |
| Secondary | Virological Relapse After End of Treatment | Up to 24 weeks after EOT (up to 118 weeks) | Virological relapse defined as non-virological response (non-VR)/non-undetectable virological response (non-UVR) at the last HCV RNA assessment during the treatment-free follow-up period in participants with VR/UVR at EOT. Here, number of participants analyzed is the participants with end of treatment response (EoT-R) who also had an HCV RNA test at least 12 weeks after EoT or whose last follow-up HCV RNA test showed non-response (HCV RNA \>=50 IU/mL). |
| Secondary | Virological Breakthrough | Up to EOT (up to 118 weeks) | Virological breakthrough/rebound defined as non-VR/non-UVR during the treatment period (including end of treatment) in participants with prior VR/UVR or an increase of HCV RNA by \>=1 log10 during the treatment period in comparison to the lowest HCV RNA (nadir) previously measured during the treatment period in participants without VR/UVR during the treatment period. Here, Number of participants analyzed is the participants with at least 2 on-treatment HCV RNA assessments (including EoT) or 1 on-treatment HCV RNA assessment (excluding EoT) and response at EoT by backward imputation. |
| Secondary | Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions | Up to first 12 weeks of treatment | SVR 12 and 24 rates for dual therapy participants are defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) less than (\<) 50 international unit/milliliters (IU/mL) (as measured by a commercially available HCV RNA test with lower limit of detection less than or equal to \[\<=\] 50 IU/mL) at 12 or 24 weeks post completion of the treatment period. If a qualitative test was used, then the lower limit of detection has to be \<=50 IU/mL. SVR12 and 24 rates for triple therapy participants are defined as percentage of participants with undetectable HCV RNA assessed by a test with lower limit of detection \<= 50 IU/mL at 12 or 24 weeks post completion of the treatment period. Here, number of participants analyzed excluded the participants with premature withdrawal due to lack of efficacy or non-safety reasons and participants without dose reductions or interruptions during the first 99 study days. |
| Secondary | Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks | Up to 12 weeks | Percentage of participants with very rapid virological response (VRVR) (defined as VR/UVR by study week 2), rapid virological response (RVR) (defined as VR/UVR by study week 4, but no VRVR), complete early virological response (cEVR) (defined as VR/UVR by study week 12, but no VRVR or RVR) and partial early virological response (pEVR) (defined as a 2 log10 drop of HCV RNA by study week 12, but no VRVR, RVR or cEVR) were reported. |
| Secondary | Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR) | Up to 98 weeks | Extended (rapid) virological response (eRVR) defined as UVR at weeks 4 and 12 for telaprevir, and as UVR at weeks 8 and 24 for boceprevir. |
| Secondary | Duration of Overall Treatment | Up to 118 weeks | Duration of overall treatment was defined as the time between first and last administration of any study drug, in weeks. |
| Secondary | Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC) | Up to 118 weeks |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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 Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) | 24 weeks after end of treatment (up to 118 weeks) | Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy). | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) | 12 weeks after end of treatment (up to 118 weeks) | Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy). | percentage of participants | NUMBER |
| SECONDARY | Virological Response at Various on Treatment Time Points and End of Treatment (EOT) | Week 4, 12 and End of treatment (EOT) (up to 96 weeks) | Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy). | percentage of participants | NUMBER |
| SECONDARY | Virological Relapse After End of Treatment | Up to 24 weeks after EOT (up to 118 weeks) | Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy). | percentage of participants | NUMBER |
| SECONDARY | Virological Breakthrough | Up to EOT (up to 118 weeks) | Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Virological Response (SVR) in Participants With Dose Reductions or Treatment Interruptions | Up to first 12 weeks of treatment | Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy). | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Very Rapid Virological Response, Rapid Virological Response, Complete Early Virological Response and Partial Early Virological Response (pEVR) During First 12 Weeks | Up to 12 weeks | The data for all of the above mentioned virological responses were not collected and was not analyzed. | ||
| SECONDARY | Percentage of Participants Achieving Extended (Rapid) Virological Response (eRVR) | Up to 98 weeks | Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy). | percentage of participants | NUMBER |
| SECONDARY | Duration of Overall Treatment | Up to 118 weeks | Core population: treatment-naive/experienced participants who were without contraindication to Peg-IFN and RBV, end stage renal disease, major organ transplantation, co-infection with hepatitis B or HIV, acute hepatitis and with positive HCV RNA at baseline, known genotype, 1 of 6 treatment (excluding non-G1 participants receiving triple therapy). | Weeks | MEAN |
| SECONDARY | Percentage of Participants Treated According to Label/Summary of Product Characteristics (SPC) | Up to 118 weeks | The data for this outcome measure were not collected and analyzed because the standard of care has changed significantly since the development of the study protocol, this comparison was no longer of practical value. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group144
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 Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | 52.1 | 95% Confidence Interval 50.1 to 54.2 | percentage of participants | |
| Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | 49.4 | 95% Confidence Interval 44.9 to 53.9 | percentage of participants | |
| Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | 46.6 | 95% Confidence Interval 40.7 to 52.5 | percentage of participants | |
| Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | 50.5 | 95% Confidence Interval 40.0 to 61.1 | percentage of participants | |
| Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | 57.7 | 95% Confidence Interval 54.3 to 61.1 | percentage of participants | |
| Percentage of Participants With Sustained Virological Response at 24 Weeks Post Completion of the Treatment Period (SVR24) | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin | 47.7 | 95% Confidence Interval 36.8 to 58.7 | percentage of participants | |
| Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | 54.3 | 95% Confidence Interval 52.2 to 56.3 | percentage of participants | |
| Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | 51.0 | 95% Confidence Interval 46.5 to 55.5 | percentage of participants | |
| Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | 50.0 | 95% Confidence Interval 44.1 to 55.9 | percentage of participants | |
| Percentage of Participants With Sustained Virological Response at 12 Weeks Post Completion of the Treatment Period (SVR12) | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | 53.8 | 95% Confidence Interval 43.1 to 64.2 | percentage of participants |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | 2,312 | |
| Overall Study | STARTED | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | 496 | |
| Overall Study | STARTED | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | 292 | |
| Overall Study | STARTED | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | 93 | |
| Overall Study | STARTED | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | 821 | |
| Overall Study | STARTED | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin | 86 | |
| Overall Study | COMPLETED | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | 1,590 | |
| Overall Study | COMPLETED | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | 331 | |
| Overall Study | COMPLETED | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | 192 | |
| Overall Study | COMPLETED | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | 60 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events1,860
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 | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | 435 | 2,312 | |
| other | Anaemia | Blood and lymphatic system disorders | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | 141 | 496 | |
| other | Anaemia | Blood and lymphatic system disorders | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | 112 | 292 | |
| other | Anaemia | Blood and lymphatic system disorders | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | 42 | 93 | |
| other | Anaemia | Blood and lymphatic system disorders | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | 351 | 821 | |
| other | Anaemia | Blood and lymphatic system disorders | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin | 43 | 86 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | 258 | 2,312 | |
| other | Neutropenia | Blood and lymphatic system disorders | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | 64 | 496 | |
| other | Neutropenia | Blood and lymphatic system disorders | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | 35 | 292 | |
| other | Neutropenia | Blood and lymphatic system disorders | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | 25 | 93 |
1 to 10 of 1,860Source ClinicalTrials.gov
See all 1,860 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | ||
| Total, all-cause mortality | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | ||
| Total, all-cause mortality | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | ||
| Total, all-cause mortality | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | ||
| Total, all-cause mortality | Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin | ||
| Total, all-cause mortality | Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin | ||
| Total, other adverse events | Dual Therapy: Peg-IFN Alfa-2a + Ribavirin | 1,225 | 2,312 |
| Total, other adverse events | Dual Therapy: Peg-IFN Alfa-2b + Ribavirin | 287 | 496 |
| Total, other adverse events | Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin | 207 | 292 |
| Total, other adverse events | Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin | 79 | 93 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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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