A clinical trial to study the effects of Human Plasma-Derived Fibrinogen (FIB Grifols) in Patients with Congenital Afibrinogenaemia
- Conditions
- Health Condition 1: D682- Hereditary deficiency of other clotting factors
- Registration Number
- CTRI/2015/05/005798
- Lead Sponsor
- Instituto Grifols SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
Subjects (both adult and pediatric) will be eligible for entry into the study once they meet ALL of the following inclusion criteria:
1.Male or female subjects less than 70 years olda
2.Sign the written Informed Consent Form (ICF), or the subjectsâ??s parent or legal guardian signs the ICF where applicable, and the Subject Authorization Form (SAF) where applicable. Pediatric patients, as defined by local regulations, will be asked to sign an age appropriate assent form.
3.Subjects diagnosed with congenital fibrinogen deficiency manifested as afibrinogenaemia.
4.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 - will be tested locally) or at Screening Visit (sample should be drawn at least 14 days prior to infusion on Day 0 Visit to be tested at central laboratory).
5.Female subjects of child-bearing potentialb must have a negative test for pregnancy serum or urine human chorionic gonadotropin (HCG-based assay) at baseline (sample drawn within 24 hours prior to infusion on Day 0 visit)
6.Female subjects of child-bearing potentialb has agreed to practice contraception using a method of proven reliability (i.e., hormonal methods; barrier methods; intrauterine devices methods, abstinence) to prevent a pregnancy during the course of the clinical trial.
7.Subjects must be willing to comply with all aspects of the clinical trial protocol, including blood sampling, for the whole duration of the study.
a)The enrollment of pediatric subjects ( <18 years of age) will be initiated only after the safety of FIB Grifols in all adult subjects has been evaluated by the sponsor.
b)Women of child-bearing potential include any female who has experienced menarche and who has not undergone successful surgical sterilisation (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (post-menopausal is defined as amenorrhea for >12 consecutive months or women on hormone replacement therapy with documented serum follicle stimulating hormone level <35 mIU/mL). Even in women who are using oral, implanted or injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile, e.g. vasectomy, should be considered to be of child bearing potential.
Subjects will be ineligible for entry into the study if they meet ANY of the following exclusion criteria:
1.Subjects who received any fibrinogen-containing product within 21 days prior to Day 0 visit .
2.Subjects who present with active bleeding within 10 days prior to infusion on Day 0 .
3.Subjects with acquired (secondary) fibrinogen deficiency.
4.Subjects diagnosed with dysfibrinogenemia
5.Subjects with documented history of deep vein thrombosis (DVT), pulmonary embolism or arterial thrombosis within
1 year prior to enrolment in this clinical trial.
6.Subjects with known antibodies against fibrinogen.
7.Subjects with a history of severe anaphylactic reactions or reactions to any blood-derived product.
8.Subjects with a history of intolerance to any component of the investigational product.
9.Subjects with documented history of IgA deficiency and have antibody against IgA
10.Females who are pregnant or are nursing an infant child.
11.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).
12.Subjects with AST or (ALT) levels exceeding more than 2.5 times the ULN for the expected normal range for the testing laboratory at baseline (sample drawn within 24 hours prior to infusion on Day 0 visit).
13.Subjects with a history of chronic alcoholism or illicit drug addiction in the preceding 12 months prior to enrollment in this clinical trial.
14.Subjects with any medical condition which is likely to interfere with the evaluation of the study drug and/or the satisfactory conduct of the clinical trial according to the investigatorâ??s judgment (e.g. congenital or acquired bleeding disorders other than congenital fibrinogen deficiency, planned surgery needing blood transfusion).
15.Subjects who received aspirin-containing products and nonsteroidal anti-inflammatory drugs (NSAIDs) within 7 days prior to the Day 0 visit.
16.Subjects currently receiving, or having received within 3 months prior to enrolment into this clinical trial, any investigational drug or device.
17. Subjects who are previously administered the investigational product FIB Grifols during this clinical trial.
18.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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change on MCF from baselineTimepoint: 1-hour post-infusion
- Secondary Outcome Measures
Name Time Method Change on other thromboelastographic variables (CT, CFT, and α angle) from baselineTimepoint: 1-hour post-infusion.;Change on standard coagulation tests (TT, PT, and aPTT) from baselineTimepoint: 1-hour post-infusion.