Trial · NCT04552899
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change in Forced Vital Capacity (FVC [mL]) | From Baseline up to Week 52 | |
| Secondary | Absolute Change in 6-minute Walk Distance (6MWD) | From Baseline up to Week 52 | |
| Secondary | Absolute Change in FVC% Predicted | From Baseline up to Week 52 | |
| Secondary | Time to Disease Progression | From Baseline up to 1 year | |
| Secondary | Time to First Respiratory-related Hospitalizations | From Baseline up to 1 year | |
| Secondary | Change in University of California, San Diego-Shortness of Breath Questionnaire (UCSD-SOBQ) | At Baseline, Week 12, Week 24, Week 36 and Week 52 | The UCSD-SOBQ is a 24-item questionnaire used to assess dyspnea severity during specific activities (21 items) and limitations caused by dyspnea in daily life (4 items). Items are assessed using a 6-point scale. Total scores, once summed, can range from 0-120 with a higher score reflecting greater dyspnea severity. |
| Secondary | Change in St. George Respiratory Questionnaire (SGRQ) Total Score | At Baseline, Week 12, Week 24, Week 36 and Week 52 | The SGRQ is a 50-item respiratory-specific quality-of-life questionnaire. The questions assess the impact of disease on activity, functionality and symptoms. Each scale is scored from 0-100. A total score represents the weighted average of these three subscores. A lower score indicates best health while a higher score indicates worst health. |
| Secondary | Time to First Acute Exacerbation of Idiopathic Pulmonary Fibrosis (IPF) | From Baseline up to 1 year | |
| Secondary | Change in Carbon Monoxide Diffusing Capacity (DLCO) | At Baseline, Week 12, Week 24, Week 36 and Week 52 | |
| Secondary | Survival | From Baseline up to 1 year | Survival is measured by all-cause mortality |
| Secondary | Percentage of Participants With Adverse Events (AEs) | From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year) | |
| Secondary | Percentage of Participants With Infusion-related Reactions (IRRs) and Other Adverse Events of Special Interest | From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year) | |
| Secondary | Percentage of Participants Permanently Discontinuing Study Treatment Due to AEs | From Baseline up to 8 weeks after the last dose of study drug (up to an average of 1 year) | |
| Secondary | Plasma Concentrations of PRM-151 | Days 1, 5 and Weeks 4, 12, and 24 | |
| Secondary | Prevalence of Anti-drug Antibodies (ADAs) at Baseline | At Baseline | |
| Secondary | Percentage of Participants With ADAs During the Study | Days 1, 5 and Weeks 4, 12, 24, 36, 48, 52 and 56 |
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/NCT04552899/registered