A prospective controlled study on the effect on bleeding events and joint function in young adults with severe hemophilia A after a 6 month prophylaxis treatment compared to on demand treatment

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002757-45-GB

Enrollment

Registered

2005-09-12

Start date

2005-11-28

Completion date

Unknown

Last updated

2019-11-25

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

Conditions

Hemophilia A MedDRA version: 7.1 Level: low Classification code 10018937

Interventions

Trade Name: Kogenate Bayer 500 IU Product Name: Kogenate Bayer 500 IU Product Code: BAY 14-2222 Pharmaceutical Form: Powder and solvent for solution for

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: • Male • Severe hemophilia A (100 Exposure days to any FVIII) • On on-demand therapy with any FVIII • No history of inhibitor (screening must include a negative inhibitor assay) • Informed consent signed • Available results for HIV, HAV, HBV, HCV (can be tested at screening if not available) 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • Current or prior inhibitor (inhibitor titer of = 0.6 Bethesda units (BU)) • Planned elective orthopedic surgery during the study duration (13 months) • Presence of an additional bleeding disorder or other medical or psychological condition which could affect treatment efficacy and QoL outcome (e.g. severe symptomatic HIV infection, advanced liver disease, renal failure). • History of anaphylactic or other severe reaction to previous AHF treatment • Known hypersensitivity to the active substance, to mouse or hamster protein or to any of the excipients

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary objective is to evaluate the effect of prophylactic treatment on the number of joint bleeds in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design. ; Secondary Objective: Secondary objective is to evaluate the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment. Health-economic data will also be assessed. ;Primary end point(s): The primary endpoint will be the number of joint bleeds which will be recorded during 6 months (i.e. months 7 – 13)of prophylactic treatment and will be compared to the number of joint bleeds during the 6 months (i.e. months 1 – 6) on-demand treatment. The first month on prophylaxis will be a run-in period for stabilization and washout and will not be evaluated.	—

Measure

Time frame

Main Objective: Primary objective is to evaluate the effect of prophylactic treatment on the number of joint bleeds in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design. ; Secondary Objective: Secondary objective is to evaluate the effect of prophylactic treatment on the joint function, the number of all bleeds, and on the quality of life compared to on-demand treatment. Health-economic data will also be assessed. ;Primary end point(s): The primary endpoint will be the number of joint bleeds which will be recorded during 6 months (i.e. months 7 – 13)of prophylactic treatment and will be compared to the number of joint bleeds during the 6 months (i.e. months 1 – 6) on-demand treatment. The first month on prophylaxis will be a run-in period for stabilization and washout and will not be evaluated.

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Countries

Italy, United Kingdom

Outcome results

None listed

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