Trial · NCT02690714
A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia
NCT02690714, Phase 2, Phase 3, Completed, Prometic Biotherapeutics, Inc.; results first posted 2021-04-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia. Trials, record NCT02690714. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02690714
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Prometic Plasminogen IV Infusion in Subjects With Hypoplasminogenemia
- NCT number
- NCT02690714
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 15 participants, actual
- Lead sponsor
- Prometic Biotherapeutics, Inc.
- Conditions
- Hypoplasminogenemia, Congenital Plasminogen Deficiency
- Interventions
- Plasminogen (Human) intravenous
- First posted
- 2016-02-24
- Last updated
- 2021-08-02
- Results first posted
- 2021-04-19
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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 | Overall clinical success was defined as 50% of participants with visible or other measurable lesions achieving at least a 50% improvement in lesion number/size or functionality impact from baseline. Visible lesions were defined as lesions that could be imaged and analyzed with digital photography. Non-visible lesions were defined as lesions whose dimensions could have been assessed by medical imaging studies (eg, computed tomography, magnetic resonance imaging, ultrasound, etc) or functional assessments (eg, spirometry, audiogram, oximetry, etc).Visible lesions that had both a length and width as measured by the 1mm scale, were referred to as "measurable lesions", and visible lesions that were too small to measure by the 1mm scale (length and/or width could not have been measured) were referred to as "non-measurable lesions". |
| 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 | Plasminogen activity is a measurement of functional plasminogen levels and is therefore the most accurate and specific method to quantify active Plasminogen (Human) Intravenous concentration in participants' plasma. Primary endpoint success was defined as at least 80% of evaluable participants (ie, 8 or more) achieving the target trough levels for at least 3 measurements in 12 weeks. The target trough level was defined as an increase in plasminogen activity level of at least an absolute 10% (10 U/dL) from the participant's individual baseline level. |
| 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 | Overall clinical success was defined as 50% of participants with visible or other measurable lesions achieving at least a 50% improvement in lesion number/size or functionality impact from baseline. Visible lesions were defined as lesions that could be imaged and analyzed with digital photography. Non-visible lesions were defined as lesions whose dimensions could have been assessed by medical imaging studies (eg, computed tomography, magnetic resonance imaging, ultrasound, etc) or functional assessments (eg, spirometry, audiogram, oximetry, etc).Visible lesions that had both a length and width as measured by the 1mm scale, were referred to as "measurable lesions", and visible lesions that were too small to measure by the 1mm scale (length and/or width could not have been measured) were referred to as "non-measurable lesions". |
| Secondary | Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 12 | 12 weeks | CGI-I scores are measured at 12 and 48 weeks after study drug treatment. The CGI-I Scale is a single, clinician completed scale designed to capture the clinician's impression of the participant's disease improvement over time. For this scale, clinicians were asked to consider their experience in this population and rate the change relative to the participant's state at Baseline using a 7-point scale (1 = very much improved, 7 = very much worse). |
| Secondary | Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 48 | 48 Weeks | CGI-I scores are measured at 12 and 48 weeks after study drug treatment. The CGI-I Scale is a single, clinician completed scale designed to capture the clinician's impression of the participant's disease improvement over time. For this scale, clinicians were asked to consider their experience in this population and rate the change relative to the participant's state at Baseline using a 7-point scale (1 = very much improved, 7 = very much worse). |
| Secondary | Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment | 12 weeks | Quality of life score (QOL) was measured at baseline and at 12 and 48 weeks after study drug treatment. For the QOL assessment, participants were asked to rate their overall QOL using an 11-point scale (0 = non-functioning, 10 = normal; The QOL scale was adapted from a scale developed by the American Chronic Pain Association. |
| Secondary | Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment | 48 weeks | Quality of life score (QOL) was measured at baseline and at 12 and 48 weeks after study drug treatment. For the QOL assessment, participants were asked to rate their overall QOL using an 11-point scale (0 = non-functioning, 10 = normal; The QOL scale was adapted from a scale developed by the American Chronic Pain Association. |
| Secondary | Plasminogen Activity Trough Levels Between Week 2 and Week 120 | Week 2 to Week 120 | Plasminogen activity trough levels were measured at Weeks 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120. |
| Secondary | Plasminogen Antigen Trough Levels Between Week 2 and Week 120 | Week 2 to Week 120 | Plasminogen antigen trough levels were measured at Weeks 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120. |
| Secondary | Half-life (t1/2) of Plasminogen Activity After First Dose and at Week 12 | First dose and 12 weeks | t1/2 is time required for the plasma concentration of Plasminogen to decrease 50% in the final stage of its elimination |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group90
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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. | Plasminogen (Human) Intravenous | Total Visible/Non-Visible lesions resolved (%) | 34 | Lesions | |
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. | Plasminogen (Human) Intravenous | Total Visible/Non-Visible lesions improved (%) | 10 | Lesions | |
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. | Plasminogen (Human) Intravenous | Not applicable (not assessed) | 3 | Lesions | |
| Number and Percentage of Particpants Who Achieved the Target Plasminogen Activity Trough Levels for at Least 3 Measurements in 12 Weeks During Segment 2 | Plasminogen (Human) Intravenous | 15 | Participants | ||
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 | Plasminogen (Human) Intravenous | Total Visible/Non-Visible lesions resolved | 26 | Number of Lesions | |
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 | Plasminogen (Human) Intravenous | Total Visible/Non-Visible lesions improved | 14 | Number of Lesions | |
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 | Plasminogen (Human) Intravenous | Total Visible/Non-visible unchanged | 2 | Number of Lesions | |
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 | Plasminogen (Human) Intravenous | Not applicable/Not assessed | 5 | Number of Lesions | |
| Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 12 | Plasminogen (Human) Intravenous | CGI score 0 = Not assessed: Week 12 | 0 | Participants | |
| Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 12 | Plasminogen (Human) Intravenous | CGI score 1 = Very much improved: Week 12 | 11 | Participants |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Segment 1: Single-dose Day -4 to Day 0 | STARTED | 6.6 mg/kg Plasminogen (Human) Intravenous | 9 | |
| Segment 1: Single-dose Day -4 to Day 0 | COMPLETED | 6.6 mg/kg Plasminogen (Human) Intravenous | 9 | |
| Segment 1: Single-dose Day -4 to Day 0 | NOT COMPLETED | 6.6 mg/kg Plasminogen (Human) Intravenous | 0 | |
| Segment 2: Multi-dose Day 0 to Week 12 | STARTED | 6.6 mg/kg Plasminogen (Human) Intravenous | 15 | |
| Segment 2: Multi-dose Day 0 to Week 12 | COMPLETED | 6.6 mg/kg Plasminogen (Human) Intravenous | 15 | |
| Segment 2: Multi-dose Day 0 to Week 12 | NOT COMPLETED | 6.6 mg/kg Plasminogen (Human) Intravenous | 0 | |
| Segment 3: Extended Treatment Wks 12-48 | STARTED | 6.6 mg/kg Plasminogen (Human) Intravenous | 15 | |
| Segment 3: Extended Treatment Wks 12-48 | COMPLETED | 6.6 mg/kg Plasminogen (Human) Intravenous | 15 | |
| Segment 3: Extended Treatment Wks 12-48 | NOT COMPLETED | 6.6 mg/kg Plasminogen (Human) Intravenous | 0 | |
| Post-Wk 48: Safety Week 48 to EoS Visit | STARTED | 6.6 mg/kg Plasminogen (Human) Intravenous | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events171
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Lymph node pain | Blood and lymphatic system disorders | 6.6 mg/kg Plasminogen (Human) Intravenous | 1 | 15 | |
| other | Lymphadenopathy | Blood and lymphatic system disorders | 6.6 mg/kg Plasminogen (Human) Intravenous | 2 | 15 | |
| other | Cardiac flutter | Cardiac disorders | 6.6 mg/kg Plasminogen (Human) Intravenous | 1 | 15 | |
| other | Ehlers-Danlos syndrome | Congenital, familial and genetic disorders | 6.6 mg/kg Plasminogen (Human) Intravenous | 1 | 15 | |
| other | Deafness unilateral | Ear and labyrinth disorders | 6.6 mg/kg Plasminogen (Human) Intravenous | 1 | 15 | |
| other | Ear pain | Ear and labyrinth disorders | 6.6 mg/kg Plasminogen (Human) Intravenous | 2 | 15 | |
| other | Excessive cerumen production | Ear and labyrinth disorders | 6.6 mg/kg Plasminogen (Human) Intravenous | 1 | 15 | |
| other | Hypoacusis | Ear and labyrinth disorders | 6.6 mg/kg Plasminogen (Human) Intravenous | 1 | 15 | |
| other | Motion sickness | Ear and labyrinth disorders | 6.6 mg/kg Plasminogen (Human) Intravenous | 1 | 15 | |
| other | Tinnitus | Ear and labyrinth disorders | 6.6 mg/kg Plasminogen (Human) Intravenous | 1 | 15 |
1 to 10 of 171Source ClinicalTrials.gov
See all 171 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 6.6 mg/kg Plasminogen (Human) Intravenous | 0 | 15 |
| Total, other adverse events | 6.6 mg/kg Plasminogen (Human) Intravenous | 15 | 15 |
| Total, serious adverse events | 6.6 mg/kg Plasminogen (Human) Intravenous | 3 | 15 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02690714
GET https://conductscience.org/api/trials/v1/NCT02690714/results?page=2