Comparison of Octaplas LG and Octaplas SDPhase 1NCT01063595
A Trial to Investigate the Relative Efficacy, Safety, and Tolerability of Octaplas LG Versus Octaplas SD
A Phase 1 study testing Octaplas LG and Octaplas SD in people with Comparison of Octaplas LG and Octaplas SD, run by Octapharma at 1 site in Austria.
Trial summary
The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters. The secondary objective of the study was to compare the safety and tolerability of Octaplas LG with Octaplas SD in terms of haematological and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Comparison of Octaplas LG and Octaplas SD
- What is being tested?
- Octaplas LG and Octaplas SD
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2009to Jul 2010
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Capable of understanding and complying with all aspects of the protocol.
- Signed Informed Consent.
- Capable of understanding the plasmapheresis information sheet and sign it.
- Healthy male or female volunteers, age 18 years or older.
- Women must have negative pregnancy test (human chorionic gonadotropin [HCG] based assay).
- Women must have sufficient methods of contraception (eg, intrauterine device, oral contraception, etc).
- No clinically relevant abnormalities in medical history and general physical examination.
- Standard health insurance.
Who cannot join
- Pregnancy or lactation.
- Tattoos within the last 3 months.
- Subject was treated therapeutically with fresh frozen plasma, blood, or plasma-derived products within the last 6 months.
- Hypersensitivity to blood products or plasma proteins.
- History of angioedema.
- History of coagulation or bleeding disorder or any other known abnormality affecting coagulation, fibrinolysis, or platelet function.
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- Any clinically significant abnormal laboratory values.
- IgA deficiency.
- Seropositivity for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency virus type 1 or type 2 antibodies.
- Symptoms of a clinically relevant illness within 3 weeks before the first trial day.
- History of or suspected drug or alcohol abuse.
- Subjects currently participating in another clinical study.
- Any investigational medicinal product administration within the last 4 weeks.
Trial locations and contacts
1 site in 1 country.
Austria1 site
Department of Clinical Pharmacology - Medical University Vienna
Vienna
About this study
Official title: A Comparative, Open-label, Randomized, Cross-over Phase I Trial in Healthy Volunteers to Investigate the Relative Efficacy, Safety and Tolerability of Octaplas LG™ vs. Octaplas®
The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters. The secondary objective of the study was to compare the safety and tolerability of Octaplas LG with Octaplas SD in terms of haematological and clinical chemistry parameters and adverse event monitoring.
- Being tested
- Octaplas LG, Octaplas SD
- Keywords
- Octaplas LG, Octaplas SD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octaplas LGBiological
Octaplas LG was composed of human coagulation-active plasma treated with solvent/detergent for 1-1.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. An additional manufacturing step, involving an affinity ligand gel, removed prion proteins. Octaplas LG was provided frozen in pyrogen free plastic bags.
Octaplas SDBiological
Octaplas SD was composed of human coagulation-active plasma treated with solvent/detergent for 4-4.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. Octaplas SD was provided frozen in pyrogen free plastic bags.
| Study group | Role | What they receive |
|---|---|---|
| Octaplas LG | Experimental | Participants received 1200 mL of Octaplas LG intravenously once. Receives: Biological: Octaplas LG |
| Octaplas SD | Active comparator | Participants received 1200 mL of Octaplas SD intravenously once. Receives: Biological: Octaplas SD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI
Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.
Measured: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration
Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C
Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.
Measured: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration
Secondary outcomes (1)
Concentration of Plasmin Inhibitor
Values of plasmin inhibitor were measured by validated assays from blood samples obtained 30 minutes before plasmapheresis, 5 minutes after the end of plasmapheresis, 15 minutes and 2 hours after the end of study drug administration, and 24 hours and 7 days after initiation of plasmapheresis. The concentration of plasmin inhibitor is reported as the percentage of plasmin inhibition. A higher concentration of plasmin inhibitor results in a higher percentage of plasmin inhibition.
Measured: From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionJul 2010
- Study completionJul 2010
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Comparison of Octaplas LG and Octaplas SDStudies of the same condition, open and under way.
- More trials run by OctapharmaThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Octapharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01063595
- Sponsor's protocol ID
- LAS-203
- Status last verified
- May 2014
- First submitted
- 4 Feb 2010
- Last updated
- 20 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Jilma-Stohlawetz P, Kursten FW, Horvath M, Leitner G, List J, Marcek J, Quehenberger P, Schwameis M, Bartko J, Derhaschnig U, Jilma B. Recovery, safety, and tolerability of a solvent/detergent-treated and prion-safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers. Transfusion. 2013 Sep;53(9):1906-17. doi: 10.1111/trf.12075. Epub 2013 Jan 16.
PubMed 23320451
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Open-label, Randomized, Cross-over Phase I Trial in Healthy Volunteers to Investigate the Relative Efficacy, Safety and Tolerability of Octaplas LG™ vs. Octaplas®
- ClinicalTrials.gov ID
- NCT01063595
- Acronym / sponsor ID
- LAS-203
- Keywords
- Octaplas LG, Octaplas SD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- OctapharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 5 Feb 2010 (estimated)
- Results
- Posted 1 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study was to compare the efficacy of Octaplas LG with Octaplas SD in terms of recovery of coagulation factors and other haemostatic parameters. The secondary objective of the study was to compare the safety and tolerability of Octaplas LG with Octaplas SD in terms of haematological and clinical chemistry parameters and adverse event monitoring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Octaplas LG | Experimental | Biological: Octaplas LGParticipants received 1200 mL of Octaplas LG intravenously once. |
| Octaplas SD | Active comparator | Biological: Octaplas SDParticipants received 1200 mL of Octaplas SD intravenously once. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Capable of understanding and complying with all aspects of the protocol.
- Signed Informed Consent.
- Capable of understanding the plasmapheresis information sheet and sign it.
- Healthy male or female volunteers, age 18 years or older.
- Women must have negative pregnancy test (human chorionic gonadotropin [HCG] based assay).
Key exclusion criteria (13 listed)
- Pregnancy or lactation.
- Tattoos within the last 3 months.
- Subject was treated therapeutically with fresh frozen plasma, blood, or plasma-derived products within the last 6 months.
- Hypersensitivity to blood products or plasma proteins.
- History of angioedema.
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 LGOctaplas LG was composed of human coagulation-active plasma treated with solvent/detergent for 1-1.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. An additional manufacturing step, involving an affinity ligand gel, removed prion proteins. Octaplas LG was provided frozen in pyrogen free plastic bags. | Biological | Octaplas LG |
| Octaplas SDOctaplas SD was composed of human coagulation-active plasma treated with solvent/detergent for 4-4.5 hours to remove enveloped viruses, eg, HIV, HBV, and HCV. Octaplas SD was provided frozen in pyrogen free plastic bags. | Biological | Octaplas SD |
Primary outcome
Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI
Time frame: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration
Recovery was defined as the maximum percentage change of the coagulation factor value measured 5 minutes after the end of plasmapheresis to the coagulation factor value measured at 15 minutes or 2 hours after the end of study drug administration. The coagulation parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.
Recovery of the Haemostatic Parameters Prothrombin Time, Activated Partial Thromboplastin Time, and Protein C
Time frame: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration
Recovery was defined as the maximum (minimum for activated partial thromboplastin time) percentage change of the haemostatic parameter value measured 5 minutes after the end of plasmapheresis to the haemostatic parameter value measured at 15 minutes or 2 hours after the end of study drug administration. The haemostatic parameters were measured by validated assays from blood samples obtained 5 minutes after the end of plasmapheresis and 15 minutes and 2 hours after the end of study drug administration.
1 secondary outcome
Concentration of Plasmin Inhibitor
Time frame: From 30 minutes before plasmapheresis up to 24 hours after the end of plasmapheresis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23320451Jilma-Stohlawetz P, Kursten FW, Horvath M, Leitner G, List J, Marcek J, Quehenberger P, Schwameis M, Bartko J, Derhaschnig U, Jilma B. Recovery, safety, and tolerability of a solvent/detergent-treated and prion-safeguarded transfusion plasma in a randomized, crossover, clinical trial in healthy volunteers. Transfusion. 2013 Sep;53(9):1906-17. doi: 10.1111/trf.12075. Epub 2013 Jan 16.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Octaplas LG and Octaplas SD in people with Comparison of Octaplas LG and Octaplas SD, run by Octapharma at 1 site in Austria.
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 8 inclusion and 13 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 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 1 May 2014). 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?
Recovery of the Coagulation Factors I, II, V, VII, VIII, IX, X, and XI (time frame: From 5 minutes after the end of plasmapheresis up to 2 hours after the end of study drug administration). 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?
On the ClinicalTrials.gov record for NCT01063595, which also lists 1 linked publication.
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 20 May 2014.