Trial · NCT07887347
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability of PM647a. Quantified by frequency and severity of treatment emergent adverse events (TEAEs) | Immediately post-infusion up to Week 48 | |
| Secondary | Frequency and severity of Dose Limiting Toxicities (DLTs) | Infusion up to and including 28 days | |
| Secondary | Percentage of participants with ≥ 11 µM total serum alpha-1 antitrypsin (AAT) levels | Week 12 post-infusion | For participants treated with a dose of PM647a at or above the OBD, central laboratory quantitative immunoturbidimetry |
| Secondary | Percentage of participants with ≥ 11 µM total serum AAT levels | Week 4, Week 6, Week 12, Week 24 and Week 48 post-infusion | Central laboratory quantitative immunoturbidimetry |
| Secondary | Percentage of participants with total serum AAT levels ≥ the lower limit of normal | Week 4, Week 6, Week 12, Week 24 and Week 48 post-infusion | Central laboratory quantitative immunoturbidimetry |
| Secondary | Change in total serum AAT levels, including changes in levels of pathogenic AAT (Z-AAT) and normal (M-AAT) | Baseline to Week 4, Week 6, Week 12, Week 24, and Week 48 post-infusion | Total AAT measured by immunoturbidimetry; M-AAT and Z-AAT isoforms by liquid chromatography/mass spectrometry (LC/MS) |
| Secondary | Time from PM647a infusion to total serum AAT levels ≥ 11 µM, ≥ 20 µM, or within the normal range | Measured over the course of the study (through Week 48) | |
| Secondary | Change in Forced Expiratory Volume (FEV1) | From baseline to Week 6 and to Week 48 post-infusion | Pulmonary function testing (PFT), using standardized pre- and post-bronchodilator spirometry |
| Secondary | Change in Forced Vital Capacity (FVC) | From baseline to Week 6 and to Week 48 post-infusion | Spirometry measuring the volume of air forcibly exhaled following maximal inspiration |
| Secondary | Change in FEV1/FVC | From baseline to Week 6 and to Week 48 post-infusion | |
| Secondary | Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | From baseline to Week 6 and to Week 48 post-infusion | |
| Secondary | Change in annualized Chronic Obstructive Pulmonary Disease (COPD) exacerbations | Infusion through the Week 48 Visit compared to the 2-years prior to signing ICF | Measured by GOLD healthcare utilization criteria (severity and frequency), higher frequencies and severity indicate greater COPD exacerbation burden |
| Secondary | Change in SGRQ-C | From baseline to Weeks 12, 24, 36, and 48 post-infusion | For participants who take the St. George's Respiratory Questionnaire for COPD Patients (SGRQ-C), scores range from 0 to 100, higher scores indicate greater respiratory health impairment and poorer respiratory-related quality of life |
| Secondary | Change in CAT | From baseline to Weeks 12, 24, 36, and 48 post-infusion | Assessed by COPD Assessment Test (CAT), scores range from 0 to 40, higher scores indicate greater COPD symptom burden and a more substantial impact of COPD on daily life. |
| Secondary | Evaluation of health-related quality of life (HRQoL) | From baseline to Week 24 and Week 48 | Using the age-appropriate EuroQol 5 Dimension 5-Level instrument (EQ-5D-5L) or alternative EQ-5D version (e.g., EQ-5D-3L) as indicated by country-specific availability, scores range from 0 to 100 with higher scores indicating better health |
| Secondary | Change in Liver Stiffness using transient or shear wave elastography | From baseline to Week 24 and Week 48 | Group B Only, measured using transient or shear wave elastography |
| Secondary | Change in pathogenic AAT (Z-AAT) in the liver | From baseline to Week 12 post-infusion and, for participants undergoing optional Week 48 liver biopsy, from baseline to Week 48 post-infusion | Group B Only, measured by liver biopsy specimen |
| Secondary | Change in pathogenic AAT globule burden score | From baseline to Week 12 post-infusion and, for participants undergoing optional Week 48 liver biopsy, from baseline to Week 48 post-infusion | Group B Only, measured by liver biopsy specimen. Score ranges from 0 to 5 with a higher score indicating greater globule burden. |
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.
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