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

August 2, 2011
November 13, 2013
November 2013
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01589666 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers
Safety Study of Spray-Dried Solvent/Detergent-Treated Plasma for Infusion in Healthy Volunteers

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.

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Coagulation Defects
  • 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
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.
Interventions:
  • Biological: Spray-dried S/D-treated Plasma
  • Drug: Spray-dried S/D-treated plasma
  • Biological: Spray-dried S/D-treated Plasma
  • Biological: Spray-dried S/D-treated Plasma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
24
June 2014
June 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
United States
 
NCT01589666
RSX-102
Yes
Entegrion, Inc.
Entegrion, Inc.
Not Provided
Principal Investigator: Bradley Vince, DO Vince & Associates Clinical Research, Inc.
Entegrion, Inc.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP