INCIDENCE OF INHIBITORS IN PREVIOUSLY UNTREATED PATIENTS WITH SEVERE HEAMOPHILIA A TREATED WITH OCTANATE - AVI-40-3

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004435-22-CZ

Enrollment

Registered

2005-11-29

Start date

2005-12-13

Completion date

Unknown

Last updated

2015-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previously untreated patients with severe (FVIII:C<2%) haemophilia A, no inhibitor activity prior to admission, no concomitant therapy with Interferon, patients registered for regular treatment at the study site, informed consent obtained from parent/legal guardian or patient, no previous treatment with FVIII or blood products containing FVIII, no participation in another clinical trial 4 weeks before study start and during the study. MedDRA version: 8.0 Level: PT Classification code 10016080

Interventions

Product Name: OCTANATE Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: Factor VIII concentrate Other descriptive name: OCTANATE Concentration unit: IU international unit(s)

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: • Previously untreated patients with severe (FVIII:C =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Patients with any defined bleeding disorder other than haemophilia A (e.g. von Willebrand disease). • Patients with a FVIII:C above 2%. • Patients requiring Interferon therapy • Participation in another clinical study currently or during the past four weeks.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess immunogenicity of Octanate® in PUPs by monitoring the levels of inhibitor against FVIII (Bethesda assay) every 3-4 exposure days until the 20th exposure day and every 10th exposure day or every 3 months, whichever comes first.;Secondary Objective: To assess viral safety of Octanate® in PUPs by monitoring of viral markers for HIV, HBV, HCV, HAV, Parvovirus B19 and ALAT at baseline and at 3 month intervals. To assess the efficacy of Octanate® for prevention and/or treatment of bleeding episodes and in surgical procedures. To assess the tolerability of Octanate® by monitoring the occurrence of adverse events.;Primary end point(s): The primary endpoint is the absence or occurence of inhibitor activity after treatment start with Octanate® determined by Bethesda assay (Nijmegen method, cut-off point: 0.6 B.U.).	—

Measure

Time frame

Main Objective: To assess immunogenicity of Octanate® in PUPs by monitoring the levels of inhibitor against FVIII (Bethesda assay) every 3-4 exposure days until the 20th exposure day and every 10th exposure day or every 3 months, whichever comes first.;Secondary Objective: To assess viral safety of Octanate® in PUPs by monitoring of viral markers for HIV, HBV, HCV, HAV, Parvovirus B19 and ALAT at baseline and at 3 month intervals. To assess the efficacy of Octanate® for prevention and/or treatment of bleeding episodes and in surgical procedures. To assess the tolerability of Octanate® by monitoring the occurrence of adverse events.;Primary end point(s): The primary endpoint is the absence or occurence of inhibitor activity after treatment start with Octanate® determined by Bethesda assay (Nijmegen method, cut-off point: 0.6 B.U.).

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Countries

Czech Republic, France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026