Coagulation DefectsPhase 1NCT01589666
Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers
A Phase 1 study testing Spray-dried S/D-treated Plasma in people with Coagulation Defects, run by Entegrion, Inc. at 1 site in United States.
Trial summary
This study is a Phase 1, single-center, open-label, ascending dose study which will assess the safety and tolerability of 5 doses of spray-dried solvent/detergent treated plasma (Resusix®) in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Coagulation Defects
- What is being tested?
- Spray-dried S/D-treated Plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to 9 Sep 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject must provide written informed consent for participation in this study and valid contact information.
- Subject must be a male or postmenopausal female.
- Subject must be at least 18 years of age and not older than 55 years of age.
- Subject must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening, including no history or symptoms of respiratory or cardiac disease.
- Vital signs should be within normal limits at Screening:
- Body temperature within 97°F to 99°F
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- Heart rate 45 to 100 beats per minute (bpm)
- Systolic blood pressure (SBP) within 90 to 140 mmHg and DBP within 50 to 90 mmHg.
- Subject must have a normal (no clinically significant abnormality) EKG at Screening and prior to administration of Resusix
- PR interval within 120 and 200 mm/s
- QRS interval <120 mm/s
- QTc interval ≤440 mm/s
- Subject must have laboratory hematology values within following normal ranges:
- White blood cell count (WBC): 4,500 to 11,000/mL
- Platelet (PLT) count: 150,000 to 400,000/mL;
- Hemoglobin (Hb): 12.5 to 15.5 g/dL;
- Activated partial thromboplastin time (aPTT): 24.6 to 36.7 seconds;
- Normal PT, International Normalized Ratio (INR): 0.8 to 1.2;
- Protein C ≥90%, Protein S ≥77%;
- Antithrombin III levels (ATIII) ≥100%.
- Subject must have laboratory clinical chemistry values within normal range specified by the testing laboratory.
- BMI ≤30 kg/m2.
- Subject must have a negative toxicology screening panel (urine test including qualitative identification of PCP, barbiturates, THC, amphetamines, benzodiazepines, opiates, and cocaine.)
- Subject must be a non-drinker (≤2 alcoholic beverages per week) and a non-smoker (any tobacco products within six months prior to Screening).
- Subject must have no history of recreational (including IV) drug use (by self-declaration).
- Subject must have the ability and willingness to attend frequent visits to the study center.
Who cannot join
- Subject with lower extremity deep vein thrombosis (DVT) at Screening.
- Subject has a history of coagulopathy or thromboembolic disease.
- Subject has a first degree family member with history of venous thromboembolic disease <55 years of age or arterial thromboembolic disease <45 years of age.
- Subject has documented drug allergies with well-described reactions.
- Subject has hepatomegaly, splenomegaly, adenopathy, bruising, and/or ecchymoses identified at Screening.
- Subject is found to have positive NAT test for HIV, HBV or HCV.
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- Subject has any murmurs, rubs, or gallops on cardiac auscultation.
- Subject has had a previous transfusion at any time.
- Subject is unlikely to comply with the study protocol or, in the opinion of the investigator, would not be a suitable candidate for participation in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince & Associates Clinical Research
Overland Park, Kansas, 66212
About this study
This study is a Phase 1, single-center, open-label, ascending dose study which will assess the safety and tolerability of 5 doses of spray-dried solvent/detergent treated plasma (Resusix®) in healthy volunteers.
- Conditions
- Coagulation Defects
- Being tested
- Spray-dried S/D-treated Plasma
- Keywords
- Entegrion, Spray-dried Solvent/Detergent Plasma, Fresh Frozen Plasma, Transfusion, Resuscitation, Hemorrhage, Coagulopathy
- Medical subject headings
- Hemostatic Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spray-dried S/D-treated PlasmaBiological
Also called Resusix
Infusion of 100 mL Spray-dried S/D-treated Plasma
Spray-dried S/D-treated plasmaDrug
Also called Resusix
Infusion of 200mL Spray-dried S/D-treated plasma
Spray-dried S/D-treated PlasmaBiological
Also called Resusix
Infusion of 500 mL Spray-dried S/D-treated plasma
Spray-dried S/D-treated PlasmaBiological
Also called Resusix
Infusion of 750 mL Spray-dried S/D-treated Plasma
Spray-dried S/D-treated PlasmaBiological
Also called Resusix
Infusion of 800 mL Spray-dried S/D-treated Plasma
| Study group | Role | What they receive |
|---|---|---|
| Spray-dried S/D-treated plasma | Experimental | Resusix (Spray-Dried Solvent/Detergent-Treated Plasma) uses source plasma from U.S.-licensed facilities as the starting material. Source plasma donors are selected from the AB blood type, which is considered a "universal" product. Receives: Biological: Spray-dried S/D-treated Plasma; Drug: Spray-dried S/D-treated plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent SAEs
Incidence of treatment-emergent SAEs reported for up to 12 weeks post Resusix infusion
Measured: 12 weeks
Secondary outcomes (2)
Change from baseline of select coagulation factors
To evaluate the recovery of select coagulation factors after infusion of 2 Resusix
Measured: 30 minutes post infusion
Incidence of AEs
To evaluate the incidence of AEs for up to 12 weeks after infusion of Resusix
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startNov 2013
- Primary completion9 Sep 2016
- Study completion9 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coagulation DefectsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Entegrion, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bradley Vince, DO, Principal investigator, Vince & Associates Clinical Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01589666
- Sponsor's protocol ID
- RSX-102
- Status last verified
- Feb 2017
- First submitted
- 2 Aug 2011
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01589666
- Acronym / sponsor ID
- RSX-102
- Conditions
- Coagulation Defects
- Keywords
- Entegrion, Spray-dried Solvent/Detergent Plasma, Fresh Frozen Plasma, Transfusion, Resuscitation, Hemorrhage, Coagulopathy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Entegrion, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- 9 Sep 2016 (actual)
- Study completion
- 9 Sep 2016 (actual)
- First posted
- 2 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a Phase 1, single-center, open-label, ascending dose study which will assess the safety and tolerability of 5 doses of spray-dried solvent/detergent treated plasma (Resusix®) in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spray-dried S/D-treated plasma | Experimental | Biological: Spray-dried S/D-treated Plasma, Drug: Spray-dried S/D-treated plasmaResusix (Spray-Dried Solvent/Detergent-Treated Plasma) uses source plasma from U.S.-licensed facilities as the starting material. Source plasma donors are selected from the AB blood type, which is considered a "universal" product. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (26 listed)
- Subject must provide written informed consent for participation in this study and valid contact information.
- Subject must be a male or postmenopausal female.
- Subject must be at least 18 years of age and not older than 55 years of age.
- Subject must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening, including no history or symptoms of respiratory or cardiac disease.
- Vital signs should be within normal limits at Screening:
Key exclusion criteria (9 listed)
- Subject with lower extremity deep vein thrombosis (DVT) at Screening.
- Subject has a history of coagulopathy or thromboembolic disease.
- Subject has a first degree family member with history of venous thromboembolic disease <55 years of age or arterial thromboembolic disease <45 years of age.
- Subject has documented drug allergies with well-described reactions.
- Subject has hepatomegaly, splenomegaly, adenopathy, bruising, and/or ecchymoses identified at Screening.
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 |
|---|---|---|
| Spray-dried S/D-treated PlasmaAlso: ResusixInfusion of 100 mL Spray-dried S/D-treated Plasma | Biological | Spray-dried S/D-treated plasma |
| Spray-dried S/D-treated plasmaAlso: ResusixInfusion of 200mL Spray-dried S/D-treated plasma | Drug | Spray-dried S/D-treated plasma |
| Spray-dried S/D-treated PlasmaAlso: ResusixInfusion of 500 mL Spray-dried S/D-treated plasma | Biological | Spray-dried S/D-treated plasma |
| Spray-dried S/D-treated PlasmaAlso: ResusixInfusion of 750 mL Spray-dried S/D-treated Plasma | Biological | Spray-dried S/D-treated plasma |
| Spray-dried S/D-treated PlasmaAlso: ResusixInfusion of 800 mL Spray-dried S/D-treated Plasma | Biological | Spray-dried S/D-treated plasma |
Primary outcome
Incidence of treatment-emergent SAEs
Time frame: 12 weeks
Incidence of treatment-emergent SAEs reported for up to 12 weeks post Resusix infusion
2 secondary outcomes
Change from baseline of select coagulation factors
Time frame: 30 minutes post infusion
Incidence of AEs
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
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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.
Bradley Vince, DO principal investigator
Vince & Associates Clinical Research, Inc.
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 Spray-dried S/D-treated Plasma in people with Coagulation Defects, run by Entegrion, Inc. at 1 site 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 26 inclusion and 9 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 7 Feb 2017. 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 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment-emergent SAEs (time frame: 12 weeks). 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 7 Feb 2017.