Trial · NCT01866930
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) | Follow-up week 12 | The analysis was performed in all treated subjects using modified intent-to-treat algorithm, where the numerator is based on subjects meeting the response criteria and the denominator is based on all treated subjects (Non-completer = Failure). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Rapid Virologic Response (RVR) and Extended Rapid Virologic Response (eRVR) | Treatment weeks 4 and 12 | The analysis was performed in all treated subjects using modified intent-to-treat algorithm, where the numerator is based on subjects meeting the response criteria and the denominator is based on all treated subjects (Non-completer = Failure). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Subjects With Sustained Virologic Response at Post-treatment Week 24 (SVR24) | Follow-up week 24 | The analysis was performed in all treated subjects using modified intent-to-treat algorithm (numerator is based on subjects meeting the response criteria and the denominator is based on all treated subjects (Non-completer = Failure). Data was not collected for any participants due to termination of the study. | ||
| SECONDARY | Number of Participants With Treatment Emergent Cytopenic Abnormalities | After Day 1 to end of treatment; up to Weeks 24 or 48 | Analysis was performed in all treated participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With On-treatment IFN-associated Flu-like or Musculoskeletal Symptoms | After Day 1 to end of treatment; up to Weeks 24 or 48 | Analysis was performed in all treated participants. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Died or Experienced Severe Adverse Events (SAEs), Dose Reductions of Lambda or Discontinuation Due to Adverse Events (AEs) | After Day 1 to end of treatment; up to Weeks 24 or 48 | The analysis included all treated subjects up to the end of the treatment period (Day 1 to week 24, or Day 1 to week 48 for subjects requiring those visits). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Grade 3/4 Lab Abnormalities | After Day 1 to end of treatment; up to Weeks 24 or 48 | The analysis included all treated subjects up to the end of the treatment period (Day 1 to week 24, or Day 1 to week 48 for subjects requiring those visits). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | The analysis was performed in all evaluable treated participants. | Cells/uL | MEAN |
| SECONDARY | Mean Percent Change in Absolute CD4 T Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | The analysis was performed in all evaluable treated participants. | Percent change | MEAN |
| SECONDARY | Mean Change in Total Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | The analysis was performed in all evaluable treated participants. | Cells/µL | MEAN |
| SECONDARY | Mean Percent Change in Total Lymphocyte Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | The analysis was performed in all evaluable treated participants. | Percent change | MEAN |
| SECONDARY | Mean Change in Platelet Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | The analysis was performed in all evaluable treated participants. | 10^9 cells/L | MEAN |
| SECONDARY | Mean Percent Change in Platelet Count From Baseline to End of Treatment | Day 1 to end of treatment; up to week 24 or week 48 | The analysis was performed in all evaluable treated participants. | Percent change | MEAN |
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.
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GET https://conductscience.org/api/trials/v1/NCT01866930/outcomes