Trial · NCT01447446
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| 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 | |
| Secondary | Percentage of Participants Who Discontinued Treatment With PEG-IFN and Ribavirin (RBV) | Up to 72 weeks of treatment | Participants who prolonged the treatment period from 72 weeks were not reported. |
| Secondary | Percentage of Participants Who Discontinued Treatment With Direct-Acting Anti-viral (DAA) | Up to 72 weeks of treatment | Participants who prolonged the treatment period from 72 weeks were not reported. Participants who discontinued their treatment as planned were included. Here, number of participant analyzed is the total number of participants who received direct-acting anti-viral (DAA). |
| Secondary | Percentage of Participants With Concomitant Medical Condition at Baseline | Baseline | |
| Secondary | Percentage of Participants With Adverse Events (AE) | Up to 118 weeks | An AE was defined as any adverse medical event that occurred after the participant used the investigational medicinal product (IMP) or other intervention behaviors specified by the protocol in the clinical trial regardless of relationship to the study treatment. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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