Adverse Effects in the Therapeutic Use of Plasma SubstitutesPhase 4OctaplasNCT01938378
Octaplas Pediatric Plasma Exchange Trial
A Phase 4 study testing Octaplas™ in people with Adverse Effects in the Therapeutic Use of Plasma Substitutes, run by Octapharma at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Adverse Effects in the Therapeutic Use of Plasma Substitutes
- What is being tested?
- Octaplas™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 8 sitesUnited States
- Study dates
- Apr 2015to 27 Jan 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patient with known homozygous congenital deficiency of Protein S.
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Octapharma Research Site
Atlanta, Georgia, 30322
Octapharma Research Site
Birmingham, Alabama, 35233
Octapharma Research Site
Cincinnati, Ohio, 45229
Octapharma Research Site
Durham, North Carolina, 27710
Octapharma Research Site
Kansas City, Missouri, 64108
Octapharma Research Site
Minneapolis, Minnesota, 55455
Octapharma Research Site
New Orleans, Louisiana, 70118
Octapharma Research Site
St Louis, Missouri, 63130
About this study
Official title: 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
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.
- Being tested
- Octaplas™
- Keywords
- Octaplas
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octaplas™Biological
Also called octaplas
octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric patients undergoing TPE | Other | octaplas™ Receives: Biological: Octaplas™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 8 days including the 24 hour follow-up from treatment
Secondary outcomes (17)
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.
Measured: up to 8 days including the 24 hour follow-up
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: up to 8 days including the 24 hour follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2013 (estimated)
- Study startApr 2015
- Primary completion27 Jan 2019
- Study completion27 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adverse Effects in the Therapeutic Use of Plasma SubstitutesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wolfgang Frenzel, MD, Study director, Medical Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01938378
- Sponsor's protocol ID
- LAS-213
- Acronym
- Octaplas
- Status last verified
- Mar 2020
- First submitted
- 2 Sep 2013
- Last updated
- 24 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01938378
- Acronym / sponsor ID
- Octaplas / LAS-213
- Keywords
- Octaplas
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- 27 Jan 2019 (actual)
- Study completion
- 27 Jan 2019 (actual)
- First posted
- 10 Sep 2013 (estimated)
- Results
- Posted 24 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients undergoing TPE | Other | Biological: Octaplas™octaplas™ |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Patient with known homozygous congenital deficiency of Protein S.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octaplas™Also: octaplasoctaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg. | Biological | Pediatric patients undergoing TPE |
Primary outcome
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.
17 secondary outcomes
Assessment of Blood Urea Nitrogen Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Carbon Dioxide Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Chloride Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Creatinine Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Glucose Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Potassium Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Sodium Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Leukocyte Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Erythrocyte Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Hemoglobin Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Hematocrit Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Mean Corpuscular Volume Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Mean Corpuscular Hemoglobin Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Mean Corpuscular Hemoglobin Concentration Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Mean Red Cell Distribution Width Levels
Time frame: up to 8 days including the 24 hour follow-up
Assessment of Mean Ionized Calcium Levels
Time frame: up to 8 days including the 24 hour follow-up
Investigator's Assessment of Overall Safety
Time frame: up to 8 days including the 24 hour follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Frenzel, MD study director
Medical Director
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Octaplas™ in people with Adverse Effects in the Therapeutic Use of Plasma Substitutes, run by Octapharma at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.