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To assess the safety and tolerability of octaplas™ in the pediatric population by monitoring serious adverse drug reactions, adverse drug reactions (ADRs), thrombotic events (TEs), thromboembolic events (TEEs) and by measuring safety laboratory parameters in pediatric patients who require therapeutic plasma exchange.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pediatric patients undergoing TPE | Other | octaplas™ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Octaplas™ | Biological | octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange. | Monitoring of adverse drug reactions caused by the octaplas™used for plasma exchange. | up to 8 days including the 24 hour follow-up from treatment |
| Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange. | Monitoring of Thrombotic Events (TEs) and Thromboembolic Events (TEEs) caused by the octaplas™used for plasma exchange. | up to 8 days including the 24 hour follow-up from treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of Blood Urea Nitrogen Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Carbon Dioxide Levels |
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Inclusion Criteria:
Exclusion Criteria:
Patient with known homozygous congenital deficiency of Protein S.
Exclusion Criteria:
Patient has a history of severe hypersensitivity reaction to plasma-derived products or to any excipient of the investigational product.
Patient has an already known IgA deficiency with documented antibodies against IgA.
Patient is currently participating in another interventional clinical study or has participated during the past 1 month prior to study inclusion. This is not applicable to non-interventional trials and does not exclude patients who have been exposed to Investigational Medicinal Product with a washout of at least 30 days from enrollment in LAS-213. Concurrent participation in a device study will be considered on a case by case basis.
Patient is pregnant.
Use of Angiotensin-Converting-Enzyme-inhibitors within 72 hours of the start of the first infusion episode or planned used of these medications while on study.
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Frenzel, MD | Medical Director | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Octapharma Research Site | Birmingham | Alabama | 35233 | United States | ||
| Octapharma Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pediatric Patients Undergoing TPE | octaplas™ Octaplas™: octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pediatric Patients Undergoing TPE Age Group 1 | Ages 2-<12 |
| BG001 | Pediatric Patients Undergoing TPE Age Group 2 | Ages 12-<17 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange. | Monitoring of adverse drug reactions caused by the octaplas™used for plasma exchange. | Posted | Number | event | up to 8 days including the 24 hour follow-up from treatment |
|
Up to 8 days
ADRs will be elicited using a standard non-leading question such as "How have you been since the last evaluation?" If children or adolescent patients are unable to adequately understand and respond to this question, the information will be obtained from the patient's guardian and/or Investigator or study nurse
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pediatric Patients Undergoing TPE Age Group 1 | Ages 2-<12 | 1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multi-organ failure | General disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Citrate toxicity | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Eppolito | Octapharma | 201-604-1155 | michael.eppolito@octapharma.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 19, 2018 | Feb 7, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 22, 2018 | Feb 7, 2020 | SAP_001.pdf |
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|
Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. |
| up to 8 days including the 24 hour follow-up |
| Assessment of Chloride Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Creatinine Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Glucose Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Potassium Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Sodium Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Leukocyte Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Erythrocyte Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Hemoglobin Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Hematocrit Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Mean Corpuscular Volume Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Mean Corpuscular Hemoglobin Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Mean Corpuscular Hemoglobin Concentration Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Mean Red Cell Distribution Width Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Assessment of Mean Ionized Calcium Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange), during each TPE, and after each TPE. Pre-TPE is within 24 hours before TPE start; Follow-Up is 24 (+/-2) hours after TPE end. | up to 8 days including the 24 hour follow-up |
| Investigator's Assessment of Overall Safety | Excellent: defined as the treatment was well tolerated by the patient; Moderate: defined as Adverse Drug Reaction (ADR(s)) were observed, but easily resolved or not clinically significant; Poor: defined as ADR(s) were observed requiring significant medical intervention | up to 8 days including the 24 hour follow-up |
| Atlanta |
| Georgia |
| 30322 |
| United States |
| Octapharma Research Site | New Orleans | Louisiana | 70118 | United States |
| Octapharma Research Site | Minneapolis | Minnesota | 55455 | United States |
| Octapharma Research Site | Kansas City | Missouri | 64108 | United States |
| Octapharma Research Site | St Louis | Missouri | 63130 | United States |
| Octapharma Research Site | Durham | North Carolina | 27710 | United States |
| Octapharma Research Site | Cincinnati | Ohio | 45229 | United States |
| BG002 | Pediatric Patients Undergoing TPE Age Group 3 | Ages ≥17 |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
Ages ≥17
| OG003 | All Patients | All ages |
|
|
| Primary | Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange. | Monitoring of Thrombotic Events (TEs) and Thromboembolic Events (TEEs) caused by the octaplas™used for plasma exchange. | Posted | Number | event | up to 8 days including the 24 hour follow-up from treatment |
|
|
|
| Secondary | Assessment of Blood Urea Nitrogen Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | mg/dL | up to 8 days including the 24 hour follow-up |
|
|
|
| Secondary | Assessment of Carbon Dioxide Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | mmol/L | up to 8 days including the 24 hour follow-up |
|
|
|
| Secondary | Assessment of Chloride Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | mmol/L | up to 8 days including the 24 hour follow-up |
|
|
|
| Secondary | Assessment of Creatinine Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | mg/dl | up to 8 days including the 24 hour follow-up |
|
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|
| Secondary | Assessment of Glucose Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | mg/dl | up to 8 days including the 24 hour follow-up |
|
|
|
| Secondary | Assessment of Potassium Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | mmol/L | up to 8 days including the 24 hour follow-up |
|
|
|
| Secondary | Assessment of Sodium Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | mmol/L | up to 8 days including the 24 hour follow-up |
|
|
|
| Secondary | Assessment of Leukocyte Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | 10^9 cells/L | up to 8 days including the 24 hour follow-up |
|
|
|
| Secondary | Assessment of Erythrocyte Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | 10^12 cells/L | up to 8 days including the 24 hour follow-up |
|
|
|
| Secondary | Assessment of Hemoglobin Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | g/dL | up to 8 days including the 24 hour follow-up |
|
|
|
| Secondary | Assessment of Hematocrit Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | % of the blood that is red blood cells | up to 8 days including the 24 hour follow-up |
|
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| Secondary | Assessment of Mean Corpuscular Volume Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | fL | up to 8 days including the 24 hour follow-up |
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| Secondary | Assessment of Mean Corpuscular Hemoglobin Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | pg | up to 8 days including the 24 hour follow-up |
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| Secondary | Assessment of Mean Corpuscular Hemoglobin Concentration Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | g/dL | up to 8 days including the 24 hour follow-up |
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| Secondary | Assessment of Mean Red Cell Distribution Width Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange) and after each TPE. Pre-TPE is within 24 hours before TPE start; Post-TPE is 30 minutes to 3 hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | % red blood cell variation volume/size | up to 8 days including the 24 hour follow-up |
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| Secondary | Assessment of Mean Ionized Calcium Levels | Blood samples compare levels before each TPE (therapeutic plasma exchange), during each TPE, and after each TPE. Pre-TPE is within 24 hours before TPE start; Follow-Up is 24 (+/-2) hours after TPE end. | Not all patients received blood draws/multiple TPEs | Posted | Mean | Standard Deviation | mmol/L | up to 8 days including the 24 hour follow-up |
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| Secondary | Investigator's Assessment of Overall Safety | Excellent: defined as the treatment was well tolerated by the patient; Moderate: defined as Adverse Drug Reaction (ADR(s)) were observed, but easily resolved or not clinically significant; Poor: defined as ADR(s) were observed requiring significant medical intervention | Not all patients received multiple TPEs | Posted | Count of Participants | Participants | up to 8 days including the 24 hour follow-up |
|
|
|
| 15 |
| 1 |
| 15 |
| 0 |
| 15 |
| EG001 | Pediatric Patients Undergoing TPE Age Group 2 | Ages 12 - <17 | 0 | 13 | 0 | 13 | 3 | 13 |
| EG002 | Pediatric Patients Undergoing TPE Age Group 3 | Ages ≥17 | 0 | 13 | 0 | 13 | 1 | 13 |
| EG003 | All Patients | All ages | 1 | 41 | 1 | 41 | 4 | 41 |
| Pyrexia | General disorders | Systematic Assessment |
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| Inflammatory marker increased | Investigations | Systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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