NCT01938378CompletedPhase 4
An Open-label, Multicenter, Post-Marketing Requirement Study to Investigate the Safety and Tolerability of Octaplas™ in the Management of Pediatric Patients Who Require Therapeutic Plasma Exchange
Conditions
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Octapharma
- Enrollment
- 41
- Locations
- 9
- Primary Endpoint
- Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange.
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 2 Years to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients in whom therapeutic plasma exchange (TPE) is required.
- •Patient is male or female ≥ 2 years to ≤ 20 years of age.
- •Patient or patient's legal representative(s)/guardian(s) has /have given voluntarily written and signed informed consent before any study-related procedure is to be performed. If children are old enough (age usually deemed by each institution) to understand the risks and benefits of the study, they should also be informed and provide their written assent.
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-
- •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.
Outcomes
Primary Outcomes
Monitoring of Adverse Drug Reactions Caused by the Octaplas™Used for Plasma Exchange.
Time Frame: up to 8 days including the 24 hour follow-up from treatment
Monitoring of adverse drug reactions caused by the octaplas™used for plasma exchange.
Monitoring of TEs and TEEs Caused by the Octaplas™Used for Plasma Exchange.
Time Frame: up to 8 days including the 24 hour follow-up from treatment
Monitoring of Thrombotic Events (TEs) and Thromboembolic Events (TEEs) caused by the octaplas™used for plasma exchange.
Secondary Outcomes
- Assessment of Erythrocyte Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Carbon Dioxide Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Chloride Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Sodium Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Hematocrit Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Leukocyte Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Blood Urea Nitrogen Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Creatinine Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Potassium Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Mean Corpuscular Hemoglobin Concentration Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Glucose Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Hemoglobin Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Mean Corpuscular Volume Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Mean Corpuscular Hemoglobin Levels(up to 8 days including the 24 hour follow-up)
- Assessment of Mean Ionized Calcium Levels(up to 8 days including the 24 hour follow-up)
- Investigator's Assessment of Overall Safety(up to 8 days including the 24 hour follow-up)
- Assessment of Mean Red Cell Distribution Width Levels(up to 8 days including the 24 hour follow-up)
Investigators
Study Sites (9)
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