Trial · NCT01598090
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part A | Assessed at Week 4 and Week 12, week 12 reported | 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. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | Follow-up Week 12 | 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. | Percentage of participants | NUMBER |
| 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 | Safety analysis included all treated participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part A | Follow-up Week 12 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Subjects With Sustained Virologic Response at Follow-Up Week 24 (SVR24) - Part A | Follow up week 24 | Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Treatment-Naïve Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) - Part B | Follow-up Week 12 | 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 treatment-naive treated participants. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Treatment Emergent Cytopenic Abnormalities - Part B | After Day 1 of treatment up to Week 48 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Extended Rapid Virologic Response (eRVR) - Part B | Week 4 and Week 12 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With On-Treatment Flu-Like Symptoms And Musculoskeletal Symptoms- Part B | After Day 1 of treatment up to Week 48 | 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. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Sustained Virologic Response at Follow- upWeek 24 (SVR24) - Part B | Follow-up Week 24 | Analysis was performed using Observed value method, defined as proportions of participants meeting response criteria in numerator and denominator - all treated participants with HCV RNA measured at follow-up Week 24. Analysis was performed in all treated participants with HCV RNA measured at follow-up Week 24 due to early study termination. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Rash | After Day 1 of treatment up to Week 48 | The analysis was performed in all treated participants. | Percentage of participants | NUMBER |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01598090/outcomes