Hemophilia ANCT00864552
International PMS Study - KOGENATE Bayer
An observational study of Hemophilia A, run by Bayer at 10 sites in 10 countries.
Trial summary
To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Kogenate (BAY14-2222)
- How many people
- 200 participants
- Where
- 10 sitesin 10 countries
- Study dates
- Dec 2002to Dec 2005
- Phase
- Observational
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with severe haemophilia A (<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII
Who may be able to join
- Patients with severe haemophilia A (<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII
Who cannot join
- Exclusion criteria must be read in conjunction with the product information (SmPC)
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
About this study
To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand.
To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.
- Conditions
- Hemophilia A
- Being tested
- Kogenate (BAY14-2222)
- Keywords
- Hemophilia A, Recombinant Factor VIII
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kogenate (BAY14-2222)Drug
Patients with severe haemophilia A (<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Drug: Kogenate (BAY14-2222) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startDec 2002
- Study completionDec 2005
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 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
- NCT00864552
- Sponsor's protocol ID
- 11145
- Other IDs
- 12252 - KG0201CH,, 12253 - KG0201BE,, 12256 - KG0201AT,, 12258 - KG0201IT,, 12259 - KG0201GR,, 12260 - KG0201ES,, 12261 - KG0201FR,, 12264 - KG0201SE,
- Status last verified
- Jun 2009
- First submitted
- 17 Mar 2009
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International PMS Study - KOGENATE Bayer
- ClinicalTrials.gov ID
- NCT00864552
- Acronym / sponsor ID
- 11145
- Conditions
- Hemophilia A
- Keywords
- Hemophilia A, Recombinant Factor VIII
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Dec 2002
- Study completion
- Dec 2005 (actual)
- First posted
- 18 Mar 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.
To evaluate long-term safety (primarily by recording adverse events including inhibitors), efficacy and patient acceptance of KOGENATE Bayer in home treatment either on prophylaxis or on demand.
To evaluate both safety and efficacy with respect to lot variability, in particular regarding lot-groups formulated with or without fix between.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Drug: Kogenate (BAY14-2222) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with severe haemophilia A (<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII
Key inclusion criteria (1 listed)
- Patients with severe haemophilia A (<2% FVIII baseline plasma levels) treated with KOGENATE Bayer as their only source of recombinant FVIII
Key exclusion criteria (1 listed)
- Exclusion criteria must be read in conjunction with the product information (SmPC)
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 |
|---|---|---|
| Kogenate (BAY14-2222)Patients with severe haemophilia A (<2% FVIII:C baseline level) treated with Kogenate Bayer as their only source of recombinant FVIII | Drug | Group 1 |
Primary outcome
Not reported in the source record.
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 30 Jun 2009.
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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
10 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by Bayer at 10 sites in 10 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 1 inclusion and 1 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 30 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Austria, Belgium, Denmark, France, Greece and 5 more countries. 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.
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.
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 30 Jun 2009.