Hemophilia ANCT00874926
EFFEKT - Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
An observational study of Hemophilia A, run by Bayer at 17 sites in 17 countries.
Trial summary
The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- How many people
- 405 participants
- Where
- 17 sitesin 17 countries
- Study dates
- Jun 2008to Apr 2013
- 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: Haemophilia A patients, no specific study population
Who may be able to join
- Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.
Who cannot join
- Exclusion criteria must be read in conjunction with the local product information.
Trial locations and contacts
17 sites in 17 countries.
17 sites in 17 countries
Libya1 site
Study site
Many Locations
About this study
Official title: Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
The aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions.
- Conditions
- Hemophilia A
- Being tested
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Keywords
- Octocog alfa, Haemophilia A
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Factor VIII (Kogenate FS, BAY14-2222)Biological
Haemophilia A patients
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy and Safety of Kogenate Bayer/FS
Measured: After 12 months, after 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startJun 2008
- Primary completionNov 2012
- Study completionApr 2013
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
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874926
- Sponsor's protocol ID
- 13405
- Other IDs
- KG0702
- Status last verified
- Jan 2014
- First submitted
- 2 Apr 2009
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Long-term Treatment With KOGENATE Bayer/FS
- ClinicalTrials.gov ID
- NCT00874926
- Acronym / sponsor ID
- 13405
- Conditions
- Hemophilia A
- Keywords
- Octocog alfa, Haemophilia A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 405 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 3 Apr 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 aim of this international prospective, non-interventional post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer in treatment of patients with haemophilia A under daily-life treatment conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222) |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Haemophilia A patients, no specific study population
Key inclusion criteria (1 listed)
- Patients with diagnosis of haemophilia A, treated with KOGENATE Bayer/FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE Bayer/FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.
Key exclusion criteria (1 listed)
- Exclusion criteria must be read in conjunction with the local product information.
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 |
|---|---|---|
| Recombinant Factor VIII (Kogenate FS, BAY14-2222)Haemophilia A patients | Biological | Group 1 |
Primary outcome
Efficacy and Safety of Kogenate Bayer/FS
Time frame: After 12 months, after 24 months
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 29 Jan 2014.
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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
17 sites in 17 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 17 sites in 17 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 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Bahrain, Bosnia and Herzegovina, Croatia, Germany, Israel and 12 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.
What does the primary outcome measure?
Efficacy and Safety of Kogenate Bayer/FS (time frame: After 12 months, after 24 months). 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 29 Jan 2014.