International clinical study to investigate the efficacy and safety of Wiloctin in patients with inherited von willebrand disease (vWD)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-002857-54-DE

Enrollment

Registered

2006-08-10

Start date

2006-11-10

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

von Willebrand Jürgends syndrom in children under 6 years of age

Interventions

Trade Name: WILATE Product Name: Wiloctin Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with defined inherited vWD of any type, not responding to DDAVP treatment, who need treatment with plasma derived vWF may be included. Age > 6 and =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Administration of other plasma derived or blood product 72 hours before treatment. Administration of DDAVP 15 days before treatment. Administration of acetylsalicylic acid 7 days before treatment. Known history of intolerance versus plasma derived or blood products. Symptomatic infection. Severe liver or kidney disease (ALAT 5x > normal value, creatinine > 120 µmol/l). Participation in another clinical study currently or during the past four weeks. Pregnancy or lactating women.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to confirm the clinical efficacy of WILOCTIN using surrogate markers, i.e. the plasma levels of FVIII:C, vWF:Ag, vWF:CBA and vWF:RCoF before and after administration. ;Secondary Objective: Secondary objectives are to measure bleeding time (BT); to assess overall efficacy and safety and tolerability of WILOCTIN.;Primary end point(s): Plasma levels of FVIII:C, vWF:Ag, vWF:CBA and vWF:RCoF are the primary endpoints and will be measured as predefined time-points.	—

Measure

Time frame

Main Objective: The primary objective of this study is to confirm the clinical efficacy of WILOCTIN using surrogate markers, i.e. the plasma levels of FVIII:C, vWF:Ag, vWF:CBA and vWF:RCoF before and after administration. ;Secondary Objective: Secondary objectives are to measure bleeding time (BT); to assess overall efficacy and safety and tolerability of WILOCTIN.;Primary end point(s): Plasma levels of FVIII:C, vWF:Ag, vWF:CBA and vWF:RCoF are the primary endpoints and will be measured as predefined time-points.

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Countries

Germany

Outcome results

None listed

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