Trial · NCT02690714
Outcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Clinical Success in Number and Size of Lesions as Measured by Photographic or Other Imaging Modality Depending on the Organ System Affected or Change in Affected Organ Functionality at 48 Weeks. | 48 weeks | Efficacy Population Week 48-Segment 3 included all 15 enrolled participants who completed the Week 48 visit at the time of the data cut-off date of 14Dec2017. This analysis included 11 participants with 47 visible and/or non-visible lesions at baseline. All 15 participants were assessed, however only 11 participants had visible and/or non-visible lesions at baseline. | Lesions | COUNT_OF_UNITS |
| PRIMARY | Number and Percentage of Particpants Who Achieved the Target Plasminogen Activity Trough Levels for at Least 3 Measurements in 12 Weeks During Segment 2 | 12 weeks | Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Clinical Success in Number and Size of Lesions as Measured by Photographic or Other Imaging Modality Depending on the Organ System Affected or Change in Affected Organ Functionality at 12 Weeks | 12 Weeks | Efficacy population week 12 included all 15 enrolled participants who completed the week 12 visit. All 15 participants were assessed, however only 11 participants had visible and/or non-visible lesions at baseline. | Number of Lesions | COUNT_OF_UNITS |
| SECONDARY | Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 12 | 12 weeks | CGI-I population included all 15 enrolled participants who completed the week 12 (and week 48) visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 48 | 48 Weeks | CGI-I population included all 15 enrolled participants who completed the week 48 (and week 12) visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment | 12 weeks | Efficacy Population Week 48-Segment 3 included all 15 enrolled participants who completed the Week 48 visit at the time of the data cut-off date of 14Dec2017 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment | 48 weeks | Efficacy Population Week 48-Segment 3 included all 15 enrolled participants who completed the Week 48 visit at the time of the data cut-off date of 14Dec2017 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasminogen Activity Trough Levels Between Week 2 and Week 120 | Week 2 to Week 120 | Pharmacokinetic Population included any participant who had completed Segment 2, 3 and post week 48 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels. | percentage of activity | MEAN |
| SECONDARY | Plasminogen Antigen Trough Levels Between Week 2 and Week 120 | Week 2 to Week 120 | Pharmacokinetic Population included any participant who had completed Segment 2, 3 and post week 48 dosing and had provided at least 3 blood samples to measure plasminogen antigen trough levels. | mg/dL | MEAN |
| SECONDARY | Half-life (t1/2) of Plasminogen Activity After First Dose and at Week 12 | First dose and 12 weeks | Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels. | Hours | MEAN |
| SECONDARY | AUClast of Plasminogen Activity After the First Dose and at Week 12 | First dose and 12 weeks | Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels. | hr*% | MEAN |
| SECONDARY | Cmax of Plasminogen Activity After First Dose and at Week 12 | First dose and 12 weeks | Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels. | % plasminogen activity | MEAN |
| SECONDARY | Cl of Plasminogen Activity After First Dose and at Week 12 | First dose and 12 weeks | Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels. | mL/hr/kg | MEAN |
| SECONDARY | AUCinf of Plasminogen Activity After First Dose and at Week 12 | First dose and 12 weeks | Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels. | hr*% | MEAN |
| SECONDARY | MRTlast for Plasminogen Activity After First Dose and at Week 12 | First dose and 12 weeks | Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels. | hours | MEAN |
| SECONDARY | Vss for Plasminogen Activity After First Dose and at Week 12 | First dose and 12 weeks | Pharmacokinetic Population included any participant who had completed Segment 2 dosing and had provided at least 3 blood samples to measure plasminogen activity trough levels. | mL/kg | 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
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GET https://conductscience.org/api/trials/v1/NCT02690714/outcomes