Ascending Doses of Autologous FDP vs FFP

Completed · Phase 1

Conditions studied: Freeze Dried Plasma in Healthy Volunteers

In brief

Assess the safety of single infusions with RePlas FDP product at increasing fixed doses

Key facts

Study ID

NCT02930226

Run by

U.S. Army Medical Research and Development Command

People needed

30

Starts

2017-02-13

Expected to finish

2018-08-02

Last updated by the study team

2021-02-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males and non-pregnant/non-breastfeeding females;
• Minimum weight is 140 pounds, maximum weight is 220 pounds;
• Ages 18-55 years;
• Self-reports that he or she feels well and healthy;
• Scores ≥ 35 on the Duke Activity Status Index;
• Able to donate 1 unit of WB based on the AABB donor history questionnaire with modifications indicated. Subjects with history of travel which puts them at risk for Creutzfeldt-Jakob Disease (CJD) or malaria will be eligible to participate;
• Has read the educational materials on donating blood and has had his or her questions answered;
• Able and willing to provide written informed consent;
• Available for the duration of the trial, which is approximately 12 weeks for subjects in Cohort 1 and Cohort 2, Arm 4; approximately 16 weeks for Cohort 2, Arm 3 and Cohort 3 (includes time for collections, product manufacture, and infusions), and able to come to the treatment clinic for scheduled study visits;
• Females of childbearing potential should either be surgically sterile (hysterectomy or tubal ligation), or should use a highly effective, medically accepted contraceptive regimen. Highly effective methods of birth control are defined as those which result in a lower failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence, or vasectomized partner;
• All females must have a negative urine pregnancy test prior to enrollment; and
• Understands the English language.

You may not qualify if…

• Known liver, kidney, cardiovascular, neurologic, gastrointestinal, blood, endocrine/metabolic, autoimmune or pulmonary disease, or treated or untreated hypertension;
• Cancer of any kind, under treatment or resolved;
• Known or past coagulopathy conditions;
• Any conditions, medications, etc. on the AABB medical deferral list;
• Past history of asthma (defined as use of a prescribed daily asthma controller medication or required asthma medication in the past 2 weeks);
• Past diagnosis of stroke, deep vein thrombosis, or transient ischemic attack
• Family history of venous or arterial thrombosis before the age of 50 in first-degree relatives (i.e., biological parents, full siblings, or children);
• History of abnormal electrocardiogram (EKG);
• Current smoker (defined as having smoked within the last 6 months);
• Known Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS)-related illness or received a positive test result for HIV infection;
• Positive test for Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) or Human T-cell Lymphotropic Virus (HTLV);
• History or significant treated or untreated mental health issues;
• Female subject who is pregnant, lactating, or with a positive pregnancy test;
• Currently taking an antibiotic or another medication for an infection;
• Treatment or use of aspirin (or other platelet inhibiting agents) within 14 days of study donation and infusion visits;
• Currently using any medications for anticoagulant therapy;
• Previous use of clotting factor concentrate(s);
• Receipt of blood or blood products within the past 12 months;
• In the past week, has had a headache and fever at the same time;
• Known intolerance to any excipients (citrate) in the study drug formulation;
• Systolic blood pressure greater than 140 mmHg;
• Diastolic blood pressure greater than 90 mmHg;
• Temperature greater than 100°F;
• Known hematocrit less than 38% for both male and female donors;
• Positive direct antiglobulin test (DAT);

Where it is running

• Hoxworth Blood Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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