Status:
COMPLETED
rFVIII-Fc (Produced by AryoGen Pharmed Co.) Pharmacokinetic Study
Lead Sponsor:
AryoGen Pharmed Co.
Conditions:
Severe Hemophilia A
Eligibility:
MALE
12+ years
Phase:
PHASE3
Brief Summary
The study is designed as a randomized, two-armed, double-blind, single-dose, crossover, two-sequence, active-controlled, multi-center, bioequivalence clinical trial with a primary endpoint of dose-nor...
Eligibility Criteria
Inclusion
- Male patients ≥ 12 years, with signed informed consent by the patient, or the patient's legally authorized representative for patients under the legal age
- Diagnosed with severe hemophilia A (endogenous FVIII \<1% \[1 IU/dL\])
- History of at least 150 documented prior exposure days to any FVIII product
- Having adequate bone marrow and organ function:
- Plt ≥ 80,000 cells/µL
- Hb ≥ 8 mg/dL
- eGFR ≥ 30 mL/min
- ALT or AST ≤ 5×ULN
- Serum bilirubin ≤ 1.5×ULN
Exclusion
- Measurable anti-drug antibody activity against FVIII (≥ 0.6 BU/mL) at screening or a history of developing anti FVIII antibody
- History of other coagulation disorders except for hemophilia A
- Acute hemorrhagic state
- Infection with HCV or HBV
- HIV-positive patients
- Infusion of any products containing FVIII within 7 days prior to first administration
- Previous treatment with commercially available extended half-life FVIII products
- Receiving drugs which increase bleeding tendency (e.g: Anti-coagulants, antiplatelets, omega 3, Vit E, etc.) within 2 weeks of screening. NSAIDs are permitted.
- Current systemic treatment with immunosuppressive drugs
- Hypersensitivity or anaphylaxis associated with any FVIII concentrate or intravenous immunoglobulin (IVIG)
- Planned elective surgery
- Current enrolment or willing to enroll in any other experimental study during the time of current trial
- Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol (e.g.: physical, psychological and mental problems)
Key Trial Info
Start Date :
July 22 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 27 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06137092
Start Date
July 22 2023
End Date
September 27 2023
Last Update
November 18 2023
Active Locations (5)
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1
Seyed-Al-Shohada Hospital
Isfahan, Iran
2
Sarvar Clinic
Mashhad, Iran
3
Dastqeib Hospital
Shiraz, Iran
4
Imam Khomeini
Tehran, Iran