EUCTR2013-000261-36-FR
Active, not recruiting
Phase 1
Clinical pharmacology, efficacy and safety study of FGTW in paediatric patients with severe congenital fibrinogen deficiency
FB Biotechnologies0 sites16 target enrollmentApril 4, 2014
ConditionsAfibrinogenaemia or severe hypofibrinogenaemiaMedDRA version: 16.1Level: LLTClassification code 10052651Term: AfibrinogenaemiaSystem Organ Class: 100000004850MedDRA version: 16.1Level: PTClassification code 10051125Term: HypofibrinogenaemiaSystem Organ Class: 10005329 - Blood and lymphatic system disordersTherapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Afibrinogenaemia or severe hypofibrinogenaemia
- Sponsor
- FB Biotechnologies
- Enrollment
- 16
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed and dated informed consent form by parents or a legal representative
- •2\. Age 12 years old
- •3\. Patients with inherited afibrinogenaemia (fibrinogen antigen levels 0\.2 g/L and unclottable PT, aPTT and TT) or severe hypofibrinogenaemia defined as fibrinogen antigen levels 0\.5 g/L and activity to antigen ratio ˜ 1
- •4\. Negative results on HCG\-based pregnancy test at the selection visit, before PK/PD part and before each event to be treated for females of childbearing potential (presence of menstruation)
- •5\. Covered by healthcare insurance in accordance with local requirements
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 12
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •1\. Dysfibrinogenaemia
- •2\. Acquired fibrinogen deficiency
- •3\. Suspected present or past anticoagulation inhibitor
- •4\. Personal history of venous or arterial thrombosis or thromboembolic event
- •5\. Co\-morbidity with other/unrelated coagulopathies
- •6\. Administration of any fibrinogen concentrate or fibrinogen containing blood product during the last 15 days (applicable only if fibrinogen levels to be measured at inclusion)
- •7\. Platelet count less than 100 x 109/L
- •8\. Serum creatinine \> 2 times the upper limit of normal
- •9\. AST and / or ALT \> 5 times the upper limit of normal
- •10\. Known history of hypersensitivity or other severe reaction to any component of the investigational medicinal product
Outcomes
Primary Outcomes
Not specified
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