Status:
COMPLETED
Study on the Dose-response Relationship of Pharmacodynamic Parameters in Patients With Hemophilia With Inhibitors
Lead Sponsor:
AryoGen Pharmed Co.
Conditions:
Hemophilia A With Inhibitor
Hemophilia B With Inhibitor
Eligibility:
MALE
12+ years
Phase:
EARLY_PHASE1
Brief Summary
Randomized, double-blind, single-dose, 5 ways crossover, exploratory clinical trial evaluating four different doses of AryoSeven (eptacog alfa, activated) and NovoSeven on selected pharmacodynamic par...
Detailed Description
Randomized, double-blind, single dose, 5 ways crossover, clinical trial evaluating four different doses (10 µg/kg, 30 µg/kg, 90 µg/kg, and 270 µg/kg) of AryoSeven (recombinant human FVII activated or ...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of congenital haemophilia A or B with inhibitors to FVIII or FIX titer \>5 Bethesda Units \[BU\]
- with \> 2 episodes of bleeding/year requiring treatment with FVII infusions, not in bleeding episode
- Male adults and adolescents (\>12 years)
- Patient informed consent has been obtained \[Patients to be enrolled must also provide voluntary written informed consent to the protocol prior to screening to be eligible for the study. For adolescents, parent/legal guardian must provide consent and, wherever possible, patient assent will also be obtained. For compromised patients, their designated proxy must provide informed consent\].
- Patients willing and able to be hospitalized prior to time of study medication administration for plasma sampling (5 times during the study).
Exclusion
- Any other type of congenital or acquired coagulopathy, such as: liver disease (hepatitis), vitamin k deficiency, uremia, malignancy.
- Antibodies against Factor VII
- Ongoing bleeding prophylaxis regimens with AryoSeven/NovoSeven or planned to occur during the trial
- Platelet count less than 100.000 platelets/mcL (at screening visit)
- Any clinical sign or known history of arterial thrombotic event or deep venous- thrombosis or pulmonary embolism
- HIV positive with current CD4+ count of less than 200/µL
- Liver cirrhosis
- Factor VIII/IX immune tolerance induction regimen planned to occur during the trial
- Known hypersensitivity to the study medication
- Parallel participation in another experimental drug trial.
- Parallel participation in another marketed drug trial that may affect the primary end-point of the study.
- Concomitant diseases and/or medications, or any other conditions, that render the patient unsuitable for inclusion into the study in the judgement of the investigator.
Key Trial Info
Start Date :
December 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04789954
Start Date
December 29 2020
End Date
July 31 2022
Last Update
September 10 2022
Active Locations (1)
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1
Comprehensive Hemophilia Care Center
Tehran, Iran