Hemophilia APhase 4NCT00927667
Joint Status in Subjects With Severe Hemophilia A in Relation to Different Treatment Regimens
A Phase 4 study testing No Drug in people with Hemophilia A, run by Bayer at 15 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 35 years, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- No Drug
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 156 participants
- Where
- 15 sitesin 6 countries
- Study dates
- Jun 2009to Dec 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 35 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
15 sites in 6 countries.
15 sites in 6 countries
Germany4 sites
Study site
Bonn, North Rhine-Westphalia, 53105
Study site
Heidelberg, Baden-Wurttemberg, 69123
Study site
Magdeburg, Saxony-Anhalt, 39112
Study site
Münster, North Rhine-Westphalia, 48143
Italy4 sites
Study site
Milan, 20122
Study site
Padova, 35121
Study site
Parma, 43100
Study site
Roma, 00161
Spain2 sites
Study site
A Coruña, A Coruña, 15006
Study site
Valencia, Valencia, 46026
United Kingdom2 sites
Study site
Canterbury, Kent, CT1 3NG
Study site
London, NW3 2QG
About this study
Official title: A Diagnostic Interventional, Controlled, Cross-sectional Evaluation of Joint Status Using Magnetic Resonance Imaging in Subjects With Severe Hemophilia A Treated With Primary Prophylaxis, Secondary Prophylaxis, or On-demand Therapy
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.
- Conditions
- Hemophilia A
- Being tested
- No Drug
- Keywords
- Hemophilia A, Joint Status, Bleeds, Magnetic Resonce Imaging
- Medical subject headings
- Hemophilia A, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No DrugProcedure or surgery
Patients have received primary FVIII prophylaxis (started < 2 years of age)
No DrugProcedure or surgery
Patients have received secondary FVIII prophylaxis (started 2 - < 6 years of age)
No DrugProcedure or surgery
Patients have received secondary FVIII prophylaxis (started 6 - < 12 years of age)
No DrugProcedure or surgery
Patients have received secondary VIII prophylaxis(started 12 - 18 years of age)
No DrugProcedure or surgery
Patients have received on-demand therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Procedure: No Drug |
| Arm 2 | Experimental | Not described Receives: Procedure: No Drug |
| Arm 3 | Experimental | Not described Receives: Procedure: No Drug |
| Arm 4 | Experimental | Not described Receives: Procedure: No Drug |
| Arm 5 | Experimental | Not described Receives: Procedure: No Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum ankle MRI score
Measured: no timeframe (single visit, "snapshot" of the actual joint status)
Secondary outcomes (4)
Total MRI score of the maximum index joint
Measured: no timeframe (single visit, "snapshot" of the actual joint status)
Number of bleeds in each index joint over previous 5 years
Measured: no timeframe (medical history status)
Number of total joint bleeds and their locations over previous 5 years
Measured: no timeframe (medical history status)
Physical joint score (Gilbert Score)
Measured: no timeframe (single visit, "snapshot" of the actual joint status)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00927667
- Sponsor's protocol ID
- 12948
- Other IDs
- 2009-010147-14, 2009
- Status last verified
- Feb 2013
- First submitted
- 23 Jun 2009
- Last updated
- 20 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Diagnostic Interventional, Controlled, Cross-sectional Evaluation of Joint Status Using Magnetic Resonance Imaging in Subjects With Severe Hemophilia A Treated With Primary Prophylaxis, Secondary Prophylaxis, or On-demand Therapy
- ClinicalTrials.gov ID
- NCT00927667
- Acronym / sponsor ID
- 12948
- Conditions
- Hemophilia A
- Keywords
- Hemophilia A, Joint Status, Bleeds, Magnetic Resonce Imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 25 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No DrugPatients have received primary FVIII prophylaxis (started < 2 years of age) | Procedure or surgery | Arm 1 |
| No DrugPatients have received secondary FVIII prophylaxis (started 2 - < 6 years of age) | Procedure or surgery | Arm 2 |
| No DrugPatients have received secondary FVIII prophylaxis (started 6 - < 12 years of age) | Procedure or surgery | Arm 3 |
| No DrugPatients have received secondary VIII prophylaxis(started 12 - 18 years of age) | Procedure or surgery | Arm 4 |
| No DrugPatients have received on-demand therapy | Procedure or surgery | Arm 5 |
Primary outcome
Maximum ankle MRI score
Time frame: no timeframe (single visit, "snapshot" of the actual joint status)
4 secondary outcomes
Total MRI score of the maximum index joint
Time frame: no timeframe (single visit, "snapshot" of the actual joint status)
Number of bleeds in each index joint over previous 5 years
Time frame: no timeframe (medical history status)
Number of total joint bleeds and their locations over previous 5 years
Time frame: no timeframe (medical history status)
Physical joint score (Gilbert Score)
Time frame: no timeframe (single visit, "snapshot" of the actual joint status)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
15 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing No Drug in people with Hemophilia A, run by Bayer at 15 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Germany, Italy, Spain, Sweden, United Kingdom and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum ankle MRI score (time frame: no timeframe (single visit, "snapshot" of the actual joint status)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2013.