Russian Kogenate Pediatric Study

Conditions: Hemophilia A
MedDRA version: 17.1Level: LLTClassification code 10060612Term: Hemophilia ASystem Organ Class: 100000004850
Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

Registration Number: EUCTR2014-005253-39-Outside-EU/EEA

Lead Sponsor: Bayer HealthCare AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: A

Sex: Male

Target Recruitment: 20

Inclusion Criteria

Male - Severe hemophilia A or moderate hemophilia A - 1-12 years of age - Requiring treatment with FVIII
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) no
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

Current or prior inhibitor or familial antecedents of inhibitor - Surgery required during the study (9 months) - Positive for HIV

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objectives is to evaluate and compare the effect on frequency of joint bleeding events in severe and moderate pediatric hemophilia A patients using 3 different prophylactic regimens: once a week prophylactic treatment, twice a week or three times a week prophylactic treatment regimens.;Secondary Objective: Secondary objectives are to assess the effect of prophylactic treatment on the number of all bleeds, the clinical status (Stockholm Hemophilia Joint Score), the number of patients in each treatment group at the end of study, total monthly consumption of rFVIII-FS for each patient and to evaluate the effect of prophylaxis with rFVIII-FS on quality of life in severe and moderate Hemophilia A patients using Haemo-QoL questionnaire.;Primary end point(s): Percentage of participants with less than 2 joint bleeds during the 9-month treatment period;Timepoint(s) of evaluation of this end point: Up to 9 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • Number of Bleeds Per Participant During the 9-month Treatment Period <br>• Number of Participants With Bleeding Events During the 9-month Treatment Period<br>• Number of Participants With Joint Bleeds During the 9-month Treatment Period <br>• Number of Participants in Each Group at the End of the Study <br>• Actual Monthly rFVIII-FS Consumption<br>• Change From Baseline in Stockholm Hemophilia Joint Score at 9 Months of Treatment <br>• Haemo-QoL Standardized Total Score at 9 Months of Treatment (Completed by Participants in the Total Group)<br>• Haemo-QoL Standardized Total Score (Completed by Parents/Caregivers in the Total Group) at 9 Months of Treatment <br><br>;Timepoint(s) of evaluation of this end point: 9 months