Pharmacokinetics, Efficacy, and Safety of Human Plasma-Derived Fibrinogen (FIB Grifols) in Participants With Congenital Afibrinogenemia

Completed · Phase 1/Phase 2

Conditions studied: Congenital Afibrinogenemia

In brief

The main objective of this study was to evaluate the pharmacokinetics (PK), efficacy, and safety of human plasma-derived fibrinogen concentrate FIB Grifols after a single-dose 70 milligrams/kilogram (mg/kg) body weight administration.

Key facts

Study ID

NCT02281500

Run by

Grifols Therapeutics LLC

People needed

24

Starts

2016-07-22

Expected to finish

2019-11-11

Last updated by the study team

2022-03-31

Who can join

Age: any, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female participants less than 70 years old.
• Sign the written Informed Consent Form (ICF), or the subjects parent or legal guardian signs the ICF where applicable, and the subjects. Authorization Form where applicable. Pediatric subjects, as defined by local regulations, will be asked to sign an age appropriate assent form.
• Subjects diagnosed with congenital fibrinogen deficiency manifested as afibrinogenemia.
• Subjects with a fibrinogen level undetectable or equal or less than 30 mg/dL determined by both Clauss and antigen methods at baseline (sample drawn within 24 hours prior to infusion on Day 0 Visit) or at Screening Visit (sample drawn at least 14 days prior to infusion on Day 0 Visit).
• Female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (HCG-based assay) at baseline (sample drawn within 24 hours prior to infusion on Day 0 Visit).
• Female subjects of child-bearing potential and their partners have agreed to practice contraception using a method of proven reliability (i.e., hormonal methods; barrier methods; intrauterine devices methods) to prevent a pregnancy during the course of the clinical trial.
• Subjects ants must be willing to comply with all aspects of the clinical trial protocol, including blood sampling, for the whole duration of the study.

You may not qualify if…

• Subjects who received any fibrinogen-containing product within 21 days prior to Day 0 Visit - infusion day.
• Subjects who present with active bleeding within 10 days prior to infusion on Day 0 Visit.
• Subjects with acquired (secondary) fibrinogen deficiency.
• Subjects diagnosed with dysfibrinogenemia.
• Subjects with documented history of deep vein thrombosis, pulmonary embolism, or arterial thrombosis within 1 year prior to enrollment in this clinical trial.
• Subjects with known antibodies against fibrinogen.
• Subjects with a history of anaphylactic reactions or severe reactions to any blood-derived product.
• Subjects with a history of intolerance to any component of the investigational products.
• Subjects with a documented history of Immunoglobulin A (IgA) deficiency and antibodies against IgA.
• Females who are pregnant or are breastfeeding.
• Subjects with renal impairment (i.e., serum creatinine exceeds more than 2.0 times the upper limit of normal [ULN] at baseline [sample drawn within 24 hours prior to infusion on Day 0 Visit]).
• Subjects with aspartate aminotransferase or alanine aminotransferase levels exceeding more than 2.5 times the ULN at baseline (sample drawn within 24 hours prior to infusion on Day 0 Visit).
• Subjects with a history of chronic alcoholism or illicit drug addiction in the preceding 12 months prior to enrollment in this clinical trial.
• Subjects with any medical condition which is likely to interfere with the evaluation of the study drugs and/or the satisfactory conduct of the clinical trial according to the investigator's judgment (e.g., congenital or acquired bleeding disorders other than congenital fibrinogen deficiency, planned surgery needing blood transfusion).
• Subjects received aspirin-containing products and nonsteroidal anti-inflammatory drugs within 7 days prior to Day 0 Visit.
• Subjects currently receiving, or having received within 3 months prior to enrollment into this clinical trial, any investigational drug or device.
• Subjects who were previously administered the investigational product FIB Grifols during this clinical trial (i.e., every subject can only participate in the study once).
• Subjects who are unlikely to adhere the protocol requirements, or are likely to be uncooperative, or unable to provide a storage serum sample prior to investigational drug infusion.

Where it is running

• Northshore Long Island Jewish Medical Center — New Hyde Park, New York, United States
• S.S. Institute of Medical Sciences and Research Centre — Davangere, Karnataka, India
• St. Johns Medical College and Hospital — Bangalore, India
• Sahyadri Specialty Hospital — Pune, India
• Agenzia per l'Emofilia Centro di Riferimento Regionale per le Coaugulopatie Congenite A.O. di Carreggi — Florence, Italy
• Hôtel-Dieu de France Hospital — Beirut, Lebanon

Full record on ClinicalTrials.gov

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