Health Condition 1: D67- Hereditary factor IX deficiency
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 So
Sponsors
Reliance Life Science Pvt.Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: Male subjects aged 18 years and above at the start of treatment Documented diagnosis of severe Hemophilia B FIX deficiency FIX coagulant levels of less than 1percent Negative for serology testing of HIV 1 and 2 If serology test results of HBsAg or Hepatitis C is positive subject enrolment will be allowed only if no active disease/virus is confirmed Written and signed informed consent form by adult subject Able to adhere to study schedules and requirements
Exclusion criteria
Exclusion criteria: Subjects with history of inhibitors to FIX Any other inherited or acquired bleeding disorder Subjects who had not been previously exposed to pdFIX Subjects with abnormal laboratory parameters like Serum creatinine less than 1 point 5 times of upper normal limit AST or ALT greater than 3 times of upper normal limit Platelet count less than 100000 per micro litre Hemoglobin less than 10 gm per dL Neutrophils less than 1 point 5 into 103 per micro litre Presence or history of Hypersensitivity to pdFIX 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 Oesophageal varicose bleeding End-stage liver disease ie Child-Pugh score B or C Ongoing break-through bleeding Positive result for HIV 1 and 2 Polytrauma 1 year prior to start of treatment for the bleeding episode or surgery History of any clinically significant diseases or any 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 antiretroviral chemotherapy such as alpha-interferon prednisone equivalent to 10 mg per day or similar drugs at study start Subject participation in any other clinical trial 30 days prior to administration of IP Any other condition which investigator feels would affect interpretation of the results or render the subject at high risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the pharmacokinetics of Factor IX in subjects with severe Hemophilia B FIX deficiency FIX coagulant levels of less than 1 percentTimepoint: A total of 10 blood samples 3 mL each will be collected First sample will be collected within 1 hour prior to drug administration 0 hour and subsequent samples will be collected at 10 minutes and half hour 1hr 2hr 4hr 8hr 24hr 32hr and 48 hours after infusion | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the safety of Factor IX in subjects with severe Hemophilia BTimepoint: Vital signs will be assessed at screening & within 1 hour prior to infusion of Factor IX & then at 1hr 3hr 6hr 24hr & 48 hours post infusion Physical examination will be performed at Screening Routine clinical laboratory assessment including coagulation parameters Adverse events including early signs of allergic or hypersensitivity reactions | — |
Countries
India
Contacts
Public ContactDr Nimish Narkar
K J SOMAIYA HOSPITAL AND RESEARCH CENTRE
Outcome results
None listed