Trial · NCT01598090
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A | Assessed at Week 4 and Week 12, week 12 reported | eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL). |
| Primary | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | Follow-up Week 12 | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL). |
| Primary | Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Drug Related AEs, Discontinuation Due to AEs, Dose Reductions and Death - Part A | Day 1 of treatment up to Week 48 | An AE was defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a participant or clinical investigation participant administered an investigational (medicinal product. An SAE was defined as any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or caused prolongation of existing hospitalization. |
| Secondary | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A | Follow-up Week 12 | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ =25 IU/mL; limit of detection \~ 10 IU/mL). |
| Secondary | Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A | Follow up week 24 | SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection \~ 10 IU/mL). The analysis was performed using Modified Intent-to-Treat method defined as the proportions of participants meeting the response criteria in numerator and denominator based on all treated participants. The analysis was performed in all treated participants. |
| Secondary | Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | Follow-up Week 12 | SVR12 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation, target detected or not detected at Week 12 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL). |
| Secondary | Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B | After Day 1 of treatment up to Week 48 | Cytopenic abnormalities included anemia defined as hemoglobin \<10 grams/decilitre; neutropenia defined as Absolute neutrophil count (ANC) \<750 cubic millimetre (mm\^3); thrombocytopenia defined as platelets \<50,000 mm\^3. |
| Secondary | Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B | Week 4 and Week 12 | eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL). |
| Secondary | Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B | After Day 1 of treatment up to Week 48 | Flu-like symptoms included pyrexia, chills, and pain. Musculoskeletal symptoms included arthralgia, myalgia, and back pain. |
| Secondary | Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B | Follow-up Week 24 | SVR24 was defined as Hepatitis C virus (HCV) RNA level below lower limit of quantitation (LLOQ), target detected or not detected at Week 24 of post-treatment follow-up. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (LLOQ) =25 IU/mL; limit of detection \~ 10 IU/mL). |
| Secondary | Percentage of Participants With Rash | After Day 1 of treatment up to Week 48 | All skin reactions involving rash or rash-like events that occurred on treatment were reported. |
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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