IRCT20161202031193N3
Completed
Phase 2
An Exploratory Study to Evaluate the Dose Response Relationship of Pharmacodynamic Parameters of Aryoseven in Patients with Hemophilia A and B with Inhibitors
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Condition 1: Congenital Hemophilia A with inhibitors. Condition 2: Congenital Hemophilia B with inhibitors.
- Sponsor
- AryoGen Pharmed
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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, non in bleeding episode
- •Male adult and adolescents (\>12 years)
- •Patients 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 Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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