CLINICAL TRIAL COMPARING PHARMACODYNAMIC, PHARMACOKINETIC AND SAFETY OFA BIOSIMILAR EPTACOG ALFA (ARYOSEVEN) AND NOVOSEVEN®, INPATIENTS WITH HAEMOPHILIA A OR B WITH INHIBITORS

Phase 1

• Conditions: HAEMOPHILIA A OR B WITH INHIBITORS; MedDRA version: 20.0Level: LLTClassification code 10053752Term: Hemophilia B with anti factor IXSystem Organ Class: 100000004850; MedDRA version: 20.0Level: LLTClassification code 10053751Term: Hemophilia A with anti factor VIIISystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2019-002854-22-BG
• Lead Sponsor: Aryogen Pharmed

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-10-22
• Last Update Posted: 29 June 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 48

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 subjects
- adult and children (>12 years)
- Patients to be enrolled must also provide voluntary written informed consent to the protocol
to be eligible for the study. For minor patients, parent/legal guardian will provide
consent and, when possible, patient assent will also be obtained. For compromised patients,
their designated proxy must provide informed consent.
- For the PK/PD phase, patients will be hospitalized at time of study medication
administration for plasma sampling (2 times during the study).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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 Novoseven or planned to occur during the
trial
- Patients who have received routine (prophylactic) treatment with rFVIIa in the period
between screening visit (visit 1) and visit 2 of this study (first dose administration)
- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified