Health Condition 1: Z00-Z99- Factors influencing health status and contact with health services
Conditions
Interventions
Intervention1: Factor IX: GENERIC NAME Human Coagulation Factor IX QUALITATIVE AND
QUANTITATIVE COMPOSITION Each lyophilized powder vial contains
Factor IX IP 250 IU Protein IP NMT 0.62 g per L Sodium
Sponsors
Reliance Life science Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Aged 6 months to 65 years at the start of treatment Documented diagnosis of Fibrinogen deficiency manifested as afibrinogenaemia or severe hypofibrinogenaemia Historical plasma fibrinogen activity of 50 mgdL or levels below the limit of detection of the local assay method Acute bleeding episode spontaneous or after trauma expected to require on demand treatment for bleeding Written and signed informed consent form by adult subject or parent of minor subject or assent form signed by the subject as well as subject s legal guardian
Exclusion criteria
Exclusion criteria: Life expectancy 6 months Bleeding disorder other than congenital fibrinogen deficiency including dysfibrinogenemia Prophylactic treatment with a fibrinogen concentrate 2 weeks prior to start of treatment Treatment with Any fibrinogen concentrates or other fibrinogen containing blood product within 2 weeks prior to start of treatment for the PK phase Any coagulation active drug non-steroidal anti inflammatory drugs warfarin, coumarin derivatives, platelet aggregation inhibitors within 1 week prior to start of the PK phase or treatment for the bleeding episode or as a planned or expected medication during the time period from Day 1 until 24 hours after the last Fibrinogen infusion. Presence or history of Hypersensitivity to study medication Deep vein thrombosis or pulmonary embolism within 1 year prior to start of treatment for the bleeding episode or surgery Arterial thrombosis within 1 year prior to start of treatment for the bleeding episode or surgery Hypersensitivity to human plasma proteins Sero-positive for HIV with CD4 count 200 cells mm3 Polytrauma 1 year prior to start of treatment for the bleeding episode or surgery Acute or chronic medical condition which may in the opinion of investigator affect the conduct of the study including subjects receiving immune-modulating drugs other than anti retroviral chemotherapy such as alpha interferon prednisone equivalent to 10 mg day or similar drugs at study start Treatment with IMP in another interventional clinical study currently or during the past 4
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1). To determine the pharmacokinetics of FibrinoRel in subjects with severe congenital fibrinogen deficiency 2). To demonstrate the efficacy of FibrinoRel for on-demand treatment of acute bleeding episodes (spontaneous or after trauma) Timepoint: 1). Day1(60 minutes before infusion, 1.00, 3.00, 6.00, 12.00, 24.00 hrs. post infusion), Day2 (24 hrs), Day 4 [72 hrs (+2 Days), Day 7 [144 hrs(+2 Days )], Day 10 [216 hrs(+2 Days )], Day 14 [312 hrs(+2 Days )] 2). Screening Visit, Day 01 and Day 02 (telephonic) | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the concentration time curve AUC Response Incremental In Vivo Recovery Classical IVR Terminal elimination half life Maximum plasma concentration Time to reach maximum plasma concentration Rotational thromboelastometryTimepoint: MCF assessment at 30 min prior to drug administration 0 00 hour 1 00 3 00 and 6 00 hours after end of first infusion of documented bleeding episode Fibrinogen plasma level before and 1 hour after the end of each subsequent infusion as well as at the time of the overall clinical assessment of haemostatic efficacy | — |
Countries
India
Contacts
Public ContactDr Shailendra Prasad Verma
King George s Medical University
Outcome results
None listed