NCT00927667

Brief Summary

The joint status (knees, ankles) of patients suffering from severe Hemophilia A (too little blood clotting factor VIII in blood) is evaluated in a single magnetic resonance imaging session. No study medication is given.

Trial Health

93
On Track

Trial Health Score

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

Enrollment
156

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2009

Geographic Reach
6 countries

15 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

February 20, 2013

Status Verified

February 1, 2013

Enrollment Period

1.5 years

First QC Date

June 23, 2009

Last Update Submit

February 16, 2013

Conditions

Hemophilia A

Keywords

Hemophilia AJoint StatusBleedsMagnetic Resonce Imaging

Outcome Measures

Primary Outcomes (1)

  • Maximum ankle MRI score

    no timeframe (single visit, "snapshot" of the actual joint status)

Secondary Outcomes (4)

  • Total MRI score of the maximum index joint

    no timeframe (single visit, "snapshot" of the actual joint status)

  • Number of bleeds in each index joint over previous 5 years

    no timeframe (medical history status)

  • Number of total joint bleeds and their locations over previous 5 years

    no timeframe (medical history status)

  • Physical joint score (Gilbert Score)

    no timeframe (single visit, "snapshot" of the actual joint status)

Study Arms (5)

Arm 1

EXPERIMENTAL
Procedure: No Drug

Arm 2

EXPERIMENTAL
Procedure: No Drug

Arm 3

EXPERIMENTAL
Procedure: No Drug

Arm 4

EXPERIMENTAL
Procedure: No Drug

Arm 5

EXPERIMENTAL
Procedure: No Drug

Interventions

No DrugPROCEDURE

Patients have received primary FVIII prophylaxis (started \< 2 years of age)

Arm 1

Eligibility Criteria

Age12 Years - 35 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Males aged 12 - 35 years
  • Severe hemophilia A ( \< 1 % FVIII:C)
  • No history of Factor VIII inhibitory antibody
  • For prophylaxis groups, having received at least two prophylactic infusions per week for 45 weeks per year for the prevention of bleeding without relevant interruption and continuing until the present.
  • Complete documentation of joints bleeds and their locations prior to start of prophylaxis,
  • Bleeding history and/or treatments received during the last 5 years documented in the subjects medical records.
  • For the on-demand subjects \> 12 bleeds/year in the last 5 years.
  • Written informed consent by subject and parent/legal representative, if \< 18 years

You may not qualify if:

  • Individuals with other coagulopathies (e.g., von Willebrand disease)
  • HIV seropositive subjects
  • Individuals for whom the most clinically severe joint is not one of the 4 index joints (ankle, knee)
  • HCV seropositive individuals who underwent interferon therapy during the last 12 months
  • Individuals for whom high-magnetic exposure is contraindicated (see section 7.1)
  • Synovectomy performed within the six months prior to investigation enrollment or orthopedic surgery planned to be performed within the investigation period
  • Joint replacement
  • For the on-demand treatment group, any period greater than 8 consecutive months having received \>/= 50 IU per kg per week Factor VIII for the prevention of bleeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Unknown Facility

Heidelberg, Baden-Wurttemberg, 69123, Germany

Location

Unknown Facility

Bonn, North Rhine-Westphalia, 53105, Germany

Location

Unknown Facility

Münster, North Rhine-Westphalia, 48143, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39112, Germany

Location

Unknown Facility

Athens, 115 27, Greece

Location

Unknown Facility

Milan, 20122, Italy

Location

Unknown Facility

Padua, 35121, Italy

Location

Unknown Facility

Parma, 43100, Italy

Location

Unknown Facility

Roma, 00161, Italy

Location

Unknown Facility

A Coruña, A Coruña, 15006, Spain

Location

Unknown Facility

Valencia, Valencia, 46026, Spain

Location

Unknown Facility

Malmo, 205 02, Sweden

Location

Unknown Facility

Stockholm, 171 76, Sweden

Location

Unknown Facility

Canterbury, Kent, CT1 3NG, United Kingdom

Location

Unknown Facility

London, NW3 2QG, United Kingdom

Location

MeSH Terms

Conditions

Hemophilia AHemorrhage

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 23, 2009

First Posted

June 25, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 20, 2013

Record last verified: 2013-02

Locations

GR(1)DE(4)ES(2)GB(2)SE(2)IT(4)