Trial · NCT02557646
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| 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. |
| Secondary | Percentage of Participants With Viral Relapse or Breakthrough | Up to 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. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough is reported. |
| Secondary | Percentage of Participants With Viral Relapse or Breakthrough According to Cumulative Dose of Ribavirin | Up to 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. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with viral relapse or breakthrough in each cumulative dose group is presented. Cumulative dose was calculated as: (administered dose divided by planned dose) multiplied by 100. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each cumulative dose group (\<60%, 60-69%, 70-79%, 80-89%, and \>90%) is reported. |
| Secondary | Percentage of Participants With Viral Relapse or Breakthrough According to Starting Dose of Ribavirin | Week 4, 12, 24, at EOT Visit, 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. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose group (600 mg, 800 mg, 1000 mg, 1200 mg, and 1400 mg) is presented. |
| Secondary | Percentage of Participants With Viral Relapse or Breakthrough According to Body Weight-normalized Dose of Ribavirin | Up to 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. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each body weight-normalized dose group (\<5mg/kg/day, 5-10 mg/kg/day, 10-15 mg/kg/day, 15-20 mg/kg/day, and \>20 mg/kg/day) is presented. |
| Secondary | Percentage of Participants With Viral Relapse or Breakthrough According to Dose Reduction of Ribavirin | Up to 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. In participants with virological response, positive HCV titers measured during 24-week follow-up was interpreted as viral relapse, and positive HCV titers measured during the treatment period was interpreted as viral breakthrough. Percentage of participants with no relapse/breakthrough (none), with relapse, and with breakthrough in each dose-reduction group (none, dose reduction within 12 weeks, dose reduction after 12 weeks, dose reduction not specified) is presented. |
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.
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