Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Entegrion, Inc.
Sponsor:
Information provided by (Responsible Party):
Entegrion, Inc.
ClinicalTrials.gov Identifier:
NCT01589666
First received: August 2, 2011
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

This study is a Phase 1, single-center, open-label, ascending dose study which will assess the safety and tolerability of 4 doses of spray-dried solvent/detergent treated plasma (Resusix®) in healthy volunteers.


Condition Intervention Phase
Coagulation Defects
Biological: Spray-dried S/D-treated Plasma
Drug: Spray-dried S/D-treated plasma
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Entegrion, Inc.:

Primary Outcome Measures:
  • Incidence of treatment-emergent SAEs [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Incidence of treatment-emergent SAEs reported for up to 12 weeks post Resusix infusion


Secondary Outcome Measures:
  • Change from baseline of select coagulation factors [ Time Frame: 30 minutes post infusion ] [ Designated as safety issue: No ]
    To evaluate the recovery of select coagulation factors after infusion of 2 Resusix

  • Incidence of AEs [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    To evaluate the incidence of AEs for up to 12 weeks after infusion of Resusix


Estimated Enrollment: 24
Study Start Date: November 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spray-dried S/D-treated plasma
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.
Biological: Spray-dried S/D-treated Plasma
1-hour infusion of 500 mL Spray-dried S/D-treated Plasma
Other Name: Resusix
Drug: Spray-dried S/D-treated plasma
1-hour infusion of 1000mL Spray-dried S/D-treated plasma
Other Name: Resusix
Biological: Spray-dried S/D-treated Plasma
1-hour infusion of 100 mL Spray-dried S/D-treated plasma
Other Name: Resusix
Biological: Spray-dried S/D-treated Plasma
1-hour infusion of 200 mL Spray-dried S/D-treated Plasma
Other Name: Resusix

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subject must provide written informed consent for participation in this study and valid contact information.
  2. Subject must be a male or postmenopausal female.
  3. Subject must be at least 18 years of age and not older than 55 years of age.
  4. 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.
  5. Vital signs should be within normal limits at Screening:

    1. Body temperature within 97°F to 99°F
    2. Heart rate 45 to 100 beats per minute (bpm)
    3. Systolic blood pressure (SBP) within 90 to 140 mmHg and DBP within 50 to 90 mmHg.
  6. Subject must have a normal (no clinically significant abnormality) EKG at Screening and prior to administration of Resusix

    1. PR interval within 120 and 200 mm/s
    2. QRS interval <120 mm/s
    3. QTc interval ≤440 mm/s
  7. Subject must have laboratory hematology values within following normal ranges:

    1. White blood cell count (WBC): 4,500 to 11,000/mL
    2. Platelet (PLT) count: 150,000 to 400,000/mL;
    3. Hemoglobin (Hb): 12.5 to 15.5 g/dL;
    4. Activated partial thromboplastin time (aPTT): 21 to 33 seconds;
    5. Normal PT, International Normalized Ratio (INR): 0.8 to 1.2;
    6. Protein C and S >50% of lower limit of the reference range;
    7. Antithrombin III levels (ATIII) >75% of lower limit of the reference range.
  8. Subject must have laboratory clinical chemistry values within normal range specified by the testing laboratory.
  9. Subject must have a negative toxicology screening panel (urine test including qualitative identification of PCP, barbiturates, THC, amphetamines, benzodiazepines, opiates, and cocaine.)
  10. Subject must be a non-drinker (≤2 alcoholic beverages per week) and a non-smoker (any tobacco products within six months prior to Screening).
  11. Subject must have no history of recreational (including IV) drug use (by self-declaration).
  12. Subject must have the ability and willingness to attend frequent visits to the study center.

Exclusion Criteria:

  1. Subject with lower extremity deep vein thrombosis (DVT) at Screening.
  2. Subject has a history of coagulopathy or thromboembolic disease.
  3. 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.
  4. Subject has documented drug allergies with well-described reactions.
  5. Subject has hepatomegaly, splenomegaly, adenopathy, bruising, and/or ecchymoses identified at Screening.
  6. Subject is found to have positive NAT test for HIV, HBV or HCV.
  7. Subject has any murmurs, rubs, or gallops on cardiac auscultation.
  8. Subject has had a previous transfusion at any time.
  9. 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01589666

Locations
United States, Kansas
Vince & Associates Clinical Research Recruiting
Overland Park, Kansas, United States, 66212
Contact: Bradley Vince, DO    913-696-1601    BVince@vinceandassociates.com   
Principal Investigator: Bradley Vince, DO         
Sponsors and Collaborators
Entegrion, Inc.
Investigators
Principal Investigator: Bradley Vince, DO Vince & Associates Clinical Research, Inc.
  More Information

No publications provided

Responsible Party: Entegrion, Inc.
ClinicalTrials.gov Identifier: NCT01589666     History of Changes
Other Study ID Numbers: RSX-102
Study First Received: August 2, 2011
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Entegrion, Inc.:
Entegrion
Spray-dried Solvent/Detergent Plasma
Fresh Frozen Plasma
Transfusion
Resuscitation
Hemorrhage
Coagulopathy

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on July 24, 2014