EFFICACY AND SAFETY STUDY OF vWF SD-35-DH (WILFACTIN) IN PATIENTS UNDER LONG TERM PROPHYLAXIS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001746-17-BE

Enrollment

Registered

2007-11-12

Start date

2005-04-13

Completion date

Unknown

Last updated

2017-08-21

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

Conditions

von Willebrand disease Classification code 10047715

Interventions

Trade Name: WILFACTIN Product Name: WILFACTIN Product Code: VWF SD-35-DH Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Human von Willebrand Factor Current S

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Type 1, 2 and 3 VWD patient (VWF:RCo =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: positive VWF and/or FVIII inhibitor screening, platelets 5 times the upper normal limit, pregnant or nursing women,

Design outcomes

Primary

Measure	Time frame
Main Objective: to evaluate the efficacy of vWF SD-35-DH (WILFACTIN) in a long-term prophylaxis treatment regimen for the prevention of haemorrhages. ;Secondary Objective: to evaluate the safety of vWF SD-35-DH for long-term prophylaxis. ;Primary end point(s): Efficacy of long-term prophylaxis treatment with vWF SD-35-DH will be judged by the absence of spontaneous bleeding episodes or the clear reduction of haemorrhages. The biological efficacy of vWF SD-35-DH will be evaluated 1°) at inclusion from VWF:RCo recovery at 15 min. and 2°) during the course of the study from FVIII trough levels at 72 hours post-injection.	—

Measure

Time frame

Main Objective: to evaluate the efficacy of vWF SD-35-DH (WILFACTIN) in a long-term prophylaxis treatment regimen for the prevention of haemorrhages. ;Secondary Objective: to evaluate the safety of vWF SD-35-DH for long-term prophylaxis. ;Primary end point(s): Efficacy of long-term prophylaxis treatment with vWF SD-35-DH will be judged by the absence of spontaneous bleeding episodes or the clear reduction of haemorrhages. The biological efficacy of vWF SD-35-DH will be evaluated 1°) at inclusion from VWF:RCo recovery at 15 min. and 2°) during the course of the study from FVIII trough levels at 72 hours post-injection.

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Countries

Belgium

Outcome results

None listed

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