A Phase 2/3 interventional study of Plasminogen (Human) intravenous in Hypoplasminogenemia and Congenital Plasminogen Deficiency, sponsored by Prometic Biotherapeutics, Inc.. Completed at 2 sites in 2 countries. Open to participants aged 2 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-08-02.
Sponsored by Prometic Biotherapeutics, Inc. · Phase 2/3, Interventional, and Treatment
This is a Phase 2/3 pivotal study to evaluate pharmacokinetics (PK), efficacy, and safety of Prometic Plasminogen (Human) Intravenous Lyophilized Solution, the investigational medicinal product (IMP), in pediatric and adult subjects with hypoplasminogenemia.
This is a Phase 2/3, open-label, repeat-dose study of the PK, efficacy, and safety of the IMP, in pediatric and adult subjects with hypoplasminogenemia. The study consists of a screening period and 3 treatment segments (Segment 1,2, and 3). Subjects who have documented individual PK profiles do not need to undergo Segment 1 and can proceed directly to Segment 2. Subjects in Segment 1 will receive a single dose of 6.6 mg/kg IMP infusion. Blood samples for PK analysis will be drawn prior to infusion and subsequently through 96 hours after the infusion to establish individual PK profiles. The sample drawn prior to infusion will be used to measure the subject's baseline anti-plasminogen antibody, plasminogen activity and antigen as well as D-dimer levels. The resulting PK profile will be used to determine each subject's dosing interval in Segment 2.
Based on individual PK profiles from Segment 1 subjects will receive 6.6 mg/kg IMP infusion every second, third, or fourth day for 12 weeks in Segment 2. For subjects who directly enter Segment 2, baseline assessments will be conducted before the first dose of IMP, including a blood sample to measure the baseline anti-plasminogen antibody, plasminogen activity and antigen as well as D-dimer levels. Subjects will visit the study sites on Week 1 and subsequently every 4 weeks, and receive the IMP infusion at the study site. Blood samples will be obtained at each study visit at Weeks 4, 8 and 12 and by a home health nurse at Weeks 2, 6 and 10. Subjects will undergo clinical assessments of the disease, including but not limited to: photographic measurements of visible lesions, spirometry for subjects with pulmonary involvement, and imaging study of nonvisible lesions, as applicable. Plasma samples will be drawn before IMP administration every 2 weeks to measure the trough levels of plasminogen activity and antigen, and D-dimer.
At the end of Segment 2, subjects will have the option to participate in Segment 3 where they will continue to receive IMP for an additional 36 weeks in Norway, and until product licensing or study termination by the sponsor for subjects in the United States. Subjects will return to the study sites for assessments every 3 months to monitor subjects' clinical status and plasminogen trough levels. Subjects at the Norway site in Segment 3 should return to the study site for a safety follow-up visit 30 days after the final IMP dose. Due to the delay in product approval, subjects at the US site in Segment 3 will be allowed to enroll in treatment protocol 2002C018G and continue ongoing IMP treatment without any break in treatment. If subjects decide to not enter treatment protocol 2002C018G, then they will stop IMP and return to the study site for a safety follow-up visit 30 days after the final IMP dose.
The primary objective of this study is to achieve an increase of individual trough plasminogen activity by at least an absolute 10% (i.e., 10 U/dL) from baseline during the 12 weeks of plasminogen replacement therapy in Segment 2; and to evaluate the efficacy of plasminogen replacement therapy on clinically evident or visible symptoms of hypoplasminogenemia during the 48 weeks of dosing in Segments 2 and 3.
Prometic Biotherapeutics, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
6.6 mg/kg Plasminogen (Human) Intravenous given every 2 to 4 days by a 10- to 30-minute intravenous infusion
Biological: Plasminogen (Human) intravenous
Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
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.
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".
Time frame: 48 weeks
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 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.
Time frame: 12 weeks
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
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".
Time frame: 12 Weeks
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 12
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).
Time frame: 12 weeks
Clinical Global Impression-Global Improvement (CGI-I) Scores at Week 48
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).
Time frame: 48 Weeks
Number of Participants With Improved Quality of Life (QOL) Score After 12 Weeks of Study Treatment
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.
Time frame: 12 weeks
Number of Participants With Improved Quality of Life (QOL) Score After 48 Weeks of Study Treatment
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.
Time frame: 48 weeks
Plasminogen Activity Trough Levels Between Week 2 and 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.
Time frame: Week 2 to Week 120
Plasminogen Antigen Trough Levels Between Week 2 and 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.
Time frame: Week 2 to Week 120
Half-life (t1/2) of Plasminogen Activity After First Dose and at Week 12
t1/2 is time required for the plasma concentration of Plasminogen to decrease 50% in the final stage of its elimination
Time frame: First dose and 12 weeks
AUClast of Plasminogen Activity After the First Dose and at Week 12
AUCLast is the area under the plasma concentration-curve of Plasminogen from time 0 to the last measured concentration.
Time frame: First dose and 12 weeks
Cmax of Plasminogen Activity After First Dose and at Week 12
Cmax is the maximum plasma concentration of Plasminogen
Time frame: First dose and 12 weeks
Cl of Plasminogen Activity After First Dose and at Week 12
Cl is the volume of plasma cleared of Plasminogen per unit time
Time frame: First dose and 12 weeks
AUCinf of Plasminogen Activity After First Dose and at Week 12
AUCinf is the area under the plasma concentration-curve of Plasminogen from time 0 extrapolated to infinity
Time frame: First dose and 12 weeks
MRTlast for Plasminogen Activity After First Dose and at Week 12
MRTLast is the mean residence time of Plasminogen from time 0 to the last measured concentration
Time frame: First dose and 12 weeks
Vss for Plasminogen Activity After First Dose and at Week 12
Vss is the apparent volume of distribution at steady state of Plasminogen
Time frame: First dose and 12 weeks
This study was conducted at 2 sites, 1 in the United States (US) and 1 in Norway. The first participant was screened in May 2016 and the last participant visit was in October 2018.
| Milestone | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| Started | 9 |
| Completed | 9 |
| Not completed | 0 |
| Milestone | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
| Milestone | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
| Milestone | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| Started | 12 |
| Completed | 10 |
| Not completed | 2 |
| Withdrew: Physician decision | 1 |
| Withdrew: Withdrawal by subject | 1 |
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".
| Lesions | Plasminogen (Human) Intravenous |
|---|---|
| Total Visible/Non-Visible lesions resolved (%) | 34 |
| Total Visible/Non-Visible lesions improved (%) | 10 |
| Not applicable (not assessed) | 3 |
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.
| Participants | Plasminogen (Human) Intravenous |
|---|---|
| Number and Percentage of Particpants Who Achieved the Target Plasminogen Activity Trough Levels for at Least 3 Measurements in 12 Weeks During Segment 2 | 15 |
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".
| Number of Lesions | Plasminogen (Human) Intravenous |
|---|---|
| Total Visible/Non-Visible lesions resolved | 26 |
| Total Visible/Non-Visible lesions improved | 14 |
| Total Visible/Non-visible unchanged | 2 |
| Not applicable/Not assessed | 5 |
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).
| Participants | Plasminogen (Human) Intravenous |
|---|---|
| CGI score 0 = Not assessed: Week 12 | 0 |
| CGI score 1 = Very much improved: Week 12 | 11 |
| CGI score 2 = Much improved : Week 12 | 4 |
| CGI score 3 = Minimally improved : Week 12 | 0 |
| CGI score 4= No change : Week 12 | 0 |
| CGI score 5 = Minimally worse : Week 12 | 0 |
| CGI score 6 = Much worse : Week 12 | 0 |
| CGI score 7 = Very much worse : Week 12 | 0 |
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).
| Participants | Plasminogen (Human) Intravenous |
|---|---|
| CGI Score 0= Not assessed: Week 48 | 0 |
| CGI Score 1= Very much improved: Week 48 | 13 |
| CGI Score 2= Much improved: Week 48 | 2 |
| CGI Score 3= Minimally improved: Week 48 | 0 |
| CGI Score 4= No change: Week 48 | 0 |
| CGI Score 5= Minimally worse: Week 48 | 0 |
| CGI Score 6= Much worse: Week 48 | 0 |
| CGI Score 7= Very much worse: Week 48 | 0 |
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.
| Participants | Plasminogen (Human) Intravenous |
|---|---|
| QOL score 0 : Week 12 | 0 |
| QOL score = 1 : Week 12 | 0 |
| QOL score = 2 : Week 12 | 0 |
| QOL score = 3 : Week 12 | 0 |
| QOL score = 4 : Week 12 | 0 |
| QOL score = 5 : Week 12 | 1 |
| QOL score = 6 : Week 12 | 0 |
| QOL score = 7 : Week 12 | 0 |
| QOL score = 8 : Week 12 | 0 |
| QOL score = 9 : Week 12 | 1 |
| QOL score = 10 : Week 12 | 13 |
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.
| Participants | Plasminogen (Human) Intravenous |
|---|---|
| QOL Score 0: Week 48 | 0 |
| QOL Score 1: Week 48 | 0 |
| QOL Score 2: Week 48 | 0 |
| QOL Score 3: Week 48 | 0 |
| QOL Score 4: Week 48 | 0 |
| QOL Score 5: Week 48 | 1 |
| QOL Score 6: Week 48 | 0 |
| QOL Score 7: Week 48 | 0 |
| QOL Score 8: Week 48 | 0 |
| QOL Score 9: Week 48 | 1 |
| QOL Score 10: Week 48 | 13 |
Plasminogen activity trough levels were measured at Weeks 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.
| percentage of activity | Plasminogen (Human) Intravenous |
|---|---|
| Week 2 | 45.1 ± 15.05 |
| Week 4 | 48.9 ± 14.56 |
| Week 6 | 52.4 ± 11.45 |
| Week 8 | 48.3 ± 17.43 |
| Week 10 | 50.2 ± 12.39 |
| Week 12 | 51.0 ± 12.01 |
| Week 24 | 45.0 ± 12.88 |
| Week 36 | 45.5 ± 13.18 |
| Week 48 | 41.7 ± 16.99 |
| Week 60 | 49.0 ± 8.88 |
| Week 72 | 46.7 ± 10.97 |
| Week 84 | 51.7 ± 20.76 |
| Week 96 | 50.1 ± 20.08 |
| Week 108 | 45.0 ± 25.19 |
| Week 120 | 36.5 ± 12.02 |
Plasminogen antigen trough levels were measured at Weeks 2, 4, 6, 8, 10, 12, 24, 36, 48, 60, 72, 84, 96, 108, and 120.
| mg/dL | Plasminogen (Human) Intravenous |
|---|---|
| Week 2 | 6.550 ± 3.0457 |
| Week 4 | 7.800 ± 3.8813 |
| Week 6 | 7.268 ± 3.3155 |
| Week 8 | 6.607 ± 3.0046 |
| Week 10 | 9.460 ± 7.1543 |
| Week 12 | 7.340 ± 2.9342 |
| Week 24 | 5.913 ± 2.2181 |
| Week 36 | 6.667 ± 2.7336 |
| Week 48 | 6.973 ± 3.1299 |
| Week 60 | 6.415 ± 1.7578 |
| Week 72 | 6.083 ± 2.2851 |
| Week 84 | 7.183 ± 3.8129 |
| Week 96 | 7.656 ± 4.2030 |
| Week 108 | 6.529 ± 4.0852 |
| Week 120 | 6.550 ± 6.2933 |
t1/2 is time required for the plasma concentration of Plasminogen to decrease 50% in the final stage of its elimination
| Hours | Plasminogen (Human) Intravenous |
|---|---|
| Mean (SD) t1/2 of plasminogen after the first dose | 34 ± 11.73 |
| Mean (SD) t1/2 of plasminogen at week 12 | 39.2 ± 6.22 |
AUCLast is the area under the plasma concentration-curve of Plasminogen from time 0 to the last measured concentration.
| hr*% | Plasminogen (Human) Intravenous |
|---|---|
| Mean (SD) AUClast after first dose of plasminogen | 3063.6 ± 778.67 |
| Mean (SD) AUClast at Week 12 | 4656.0 ± 1012.66 |
Cmax is the maximum plasma concentration of Plasminogen
| % plasminogen activity | Plasminogen (Human) Intravenous |
|---|---|
| Mean (SD) Cmax of plasminogen after first dose | 95 ± 23.5 |
| Mean (SD) Cmax of plasminogen at Week 12 | 125 ± 23.3 |
Cl is the volume of plasma cleared of Plasminogen per unit time
| mL/hr/kg | Plasminogen (Human) Intravenous |
|---|---|
| Mean (SD) Cl of plasminogen after first dose | 1.44 ± 0.460 |
| Mean (SD) Cl of plasminogen at Week 12 | 0.92 ± 0.257 |
AUCinf is the area under the plasma concentration-curve of Plasminogen from time 0 extrapolated to infinity
| hr*% | Plasminogen (Human) Intravenous |
|---|---|
| Mean (SD) AUCinf of plasminogen after first dose | 3605.8 ± 1023.88 |
| Mean (SD) AUCinf of plasminogen at Week 12 | 5731.8 ± 1431.70 |
MRTLast is the mean residence time of Plasminogen from time 0 to the last measured concentration
| hours | Plasminogen (Human) Intravenous |
|---|---|
| Mean (SD) MRTlast of plasminogen after first dose | 30.6 ± 3.22 |
| Mean (SD) MRTlast of plasminogen at Week 12 | 33.5 ± 1.60 |
Vss is the apparent volume of distribution at steady state of Plasminogen
| mL/kg | Plasminogen (Human) Intravenous |
|---|---|
| Mean (SD) Vss of plasminogen after first dose | 63.3 ± 11.44 |
| Mean (SD) Vss of plasminogen at Week 12 | 49.3 ± 10.36 |
Collected over Safety was assessed during the treatment period (up to 124 weeks) and a 30-day post-treatment period.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 6.6 mg/kg Plasminogen (Human) Intravenous | 0/15 (0%) | 3/15 (20%) | 15/15 (100%) |
| Event | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| IleusGastrointestinal disorders | 1/15 |
| PneumoniaInfections and infestations | 1/15 |
| Ear operationSurgical and medical procedures | 1/15 |
| OssiculoplastySurgical and medical procedures | 1/15 |
| Event | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| NasopharyngitisInfections and infestations | 10/15 |
| HeadacheNervous system disorders | 8/15 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 8/15 |
| DiarrhoeaGastrointestinal disorders | 7/15 |
| CoughRespiratory, thoracic and mediastinal disorders | 7/15 |
| Abdominal pain upperGastrointestinal disorders | 6/15 |
| NauseaGastrointestinal disorders | 6/15 |
| PyrexiaGeneral disorders | 6/15 |
| RhinorrhoeaRespiratory, thoracic and mediastinal disorders | 6/15 |
| Abdominal painGastrointestinal disorders | 5/15 |
| Age, Continuous(years) | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| Mean | 23.0 ± 13.05 |
| Age, Customized(Participants) | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| 2-11 years | 4 |
| 12-17 years | 2 |
| > 17 years | 9 |
| Sex: Female, Male(Participants) | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| Female | 11 |
| Male | 4 |
| Race (NIH/OMB)(Participants) | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 15 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| Hispanic/Latino | 1 |
| Non-Hispanic/Latino | 14 |
| Region of Enrollment(Participants) | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| United States | 12 |
| Norway | 3 |
| Weight(Kg) | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| Mean | 60.37 ± 26.803 |
| Visible and Non-Visible Lesions by Participant(Participants) | 6.6 mg/kg Plasminogen (Human) Intravenous |
|---|---|
| None | 4 |
| >= 1 Visible or non-visible lesion | 11 |
6 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Plasminogen
Congenital Plasminogen Deficiency
Prometic Biotherapeutics, Inc.