Trial · NCT01769196
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival | Up to 148 weeks | Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria. |
| Primary | PFS Among the Participants With sLOXL2 ≥ 50th Percentile | Up to 148 weeks | |
| Primary | PFS Among the Participants With sLOXL2 ≥ 75th Percentile | Up to 148 weeks | |
| Secondary | Overall Survival (OS) | Up to 151 weeks | Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days. |
| Secondary | Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile | Up to 151 weeks | |
| Secondary | Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile | Up to 151 weeks | |
| Secondary | Relative Change From Baseline in FVC % Predicted | Weeks 54, 106, and 130 | * FVC was defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted was defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition. * Adjusted means were from mixed model repeated measures (MMRM) model with baseline FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130 * The relative change was calculated as 100% \* ( value at later time point minus value at baseline ) / value at baseline, with lower values indicating a decrease and higher values indicating an increase. |
| Secondary | Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations | Up to 148 weeks | |
| Secondary | Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations | Up to 148 weeks | |
| Secondary | Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death | Up to 148 weeks | |
| Secondary | Absolute Change From Baseline in 6 Minute Walk Distance (6MWD) | Weeks 58, 106, and 130 | * Adjusted means were from MMRM model with baseline 6MWD, FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130. * The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase. |
| Secondary | Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score | Week 58, 106, and 130 | * The SGRQ is a disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency \& severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations. * The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase. |
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/NCT01769196/registered