NCT00586521

Brief Summary

The purpose of the study is to evaluate the effect of prophylactic treatment on the number of joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand treatment in a one-group two-treatment schedule design. In addition, 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 and health-economic data will be assessed.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2006

Typical duration for phase_4

Geographic Reach
5 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 4, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 19, 2009

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

2.1 years

First QC Date

December 21, 2007

Results QC Date

April 3, 2009

Last Update Submit

October 27, 2014

Conditions

Hematologic DiseaseHemophilia A

Keywords

Coagulation Disorders

Outcome Measures

Primary Outcomes (1)

  • Number of Joint Bleeds

    Number of joint bleeds during Months 8-13 compared to number of joint bleeds during Months 1-6

    Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)

Secondary Outcomes (3)

  • Number of All Bleeds

    Months 1-6 (on-demand treatment) and 8-13 (prophylactic treatment)

  • Physical Assessment Compared to On-demand Treatment as Determined by the Gilbert Score

    Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)

  • Quality of Life Compared to On-demand Treatment as Measured by the Haemo-QoL A Questionnaire

    Month 13 (end of prophylactic treatment) and Month 6 (end of on-demand treatment)

Study Arms (1)

rFVIII-FS (octocog-alfa), (Kogenate FS)

EXPERIMENTAL

On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.

Drug: Kogenate (BAY14-2222)

Interventions

Kogenate (BAY14-2222)DRUG

One group two treatment schedules, first on-demand then switch to prophylaxis

rFVIII-FS (octocog-alfa), (Kogenate FS)

Eligibility Criteria

Age30 Years - 45 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Severe hemophilia A (\< 1% FVIII)
  • years of age
  • Previously treated subject (\> 100 Exposure days to any FVIII)
  • On-demand therapy with any FVIII

You may not qualify if:

  • No history of inhibitor
  • No planned elective orthopedic surgery during the study duration (13 months)
  • No severe concomitant disease
  • No history of anaphylactic or other severe reaction to previous FVIII treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Unknown Facility

Aurora, Colorado, 80045, United States

Location

Unknown Facility

Chapel Hill, North Carolina, 27599, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Strasbourg, 67098, France

Location

Unknown Facility

Florence, 50134, Italy

Location

Unknown Facility

Pavia, 27100, Italy

Location

Unknown Facility

Roma, 00161, Italy

Location

Unknown Facility

Madrid, Madrid, 28046, Spain

Location

Unknown Facility

Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38009, Spain

Location

Unknown Facility

Cardiff, South Glamorgan, CF14 4XW, United Kingdom

Location

Unknown Facility

Sheffield, South Yorkshire, S10 2JF, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Hematologic DiseasesHemophilia AHemostatic Disorders

Interventions

F8 protein, humanBAY 14-2222

Condition Hierarchy (Ancestors)

Hemic and Lymphatic DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesVascular DiseasesCardiovascular Diseases

Limitations and Caveats

The short observation period of 6 months may be responsible for the lack of statistical significance between treatments in the subject's overall assessment of disease-related quality of life; however, a positive trend was noted.

Results Point of Contact

Title
Therapeutic Area Head
Organization
BAYER
clinical-trials-contact@bayerhealthcare.com

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2007

First Posted

January 4, 2008

Study Start

February 1, 2006

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

November 3, 2014

Results First Posted

November 19, 2009

Record last verified: 2014-10

Locations

GB(2)IT(3)FR(1)US(3)ES(2)