Hemophilia AKG0910KRNCT01386268
Kogenate FS Regulatory Post-Marketing Surveillance
An observational study of Hemophilia A, run by Bayer at 1 site in South Korea.
Trial summary
To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications. The observation period for each patient is up to 6 months. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- How many people
- 64 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2011to Aug 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
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with hemophilia A in Korea
Who may be able to join
- Patients with diagnosis of hemophilia A
- Treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS
- Signed the informed consent form to participate in this study.
- 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
- For patients with no available inhibitor status, it should be checked as per the recommendation of KFDA
- Patients are defined as included in the study if there is a documented prescription of KOGENATE FS by the physician.
Who cannot join
- Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: KOGENATE® FS , Local Post Authorization Safety Study
To obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications.
The observation period for each patient is up to 6 months.
- Conditions
- Hemophilia A
- Being tested
- Recombinant Factor VIII (Kogenate FS, BAY14-2222)
- Keywords
- Kogenate FS, Hemophilia 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
Patients with diagnosis of hemophilia A, treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS
| 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.
Safety variables will be summarized using descriptive statistics based on adverse events collection
Measured: Up to 6 months
Secondary outcomes (4)
Type of the treatment (prophylaxis, on demand, surgery)
Measured: Initial visit and 6 month f/u or at the end of the observation visit
Total consumption of FVIII
Measured: Initial visit and 6 month f/u or at the end of the observation visit
Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively)
Measured: Initial visit, 6 month follow-up visit and 12 month follow-up visit
General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficient
Measured: 6 month f/u or at the end of observation visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJan 2013
- Study completionAug 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
- Time perspective
- Prospective
- Enrolment
- 64 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
- NCT01386268
- Sponsor's protocol ID
- 14927
- Other IDs
- KG0910KR
- Acronym
- KG0910KR
- Status last verified
- Aug 2014
- First submitted
- 14 Jun 2011
- Last updated
- 21 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KOGENATE® FS , Local Post Authorization Safety Study
- ClinicalTrials.gov ID
- NCT01386268
- Acronym / sponsor ID
- KG0910KR / 14927
- Conditions
- Hemophilia A
- Keywords
- Kogenate FS, Hemophilia A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 1 Jul 2011 (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 obtain data on safety, efficacy, and tolerability of KOGENATE FS under real-life conditions in its registered indications.
The observation period for each patient is up to 6 months.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Biological: Recombinant Factor VIII (Kogenate FS, BAY14-2222) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hemophilia A in Korea
Key inclusion criteria (7 listed)
- Patients with diagnosis of hemophilia A
- Treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS
- Signed the informed consent form to participate in this study.
- 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)
- Patients with hypersensitivity to any ingredient of KOGENATE FS or to the protein of mouse or hamster will be excluded.
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)Patients with diagnosis of hemophilia A, treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS | Biological | Group 1 |
Primary outcome
Safety variables will be summarized using descriptive statistics based on adverse events collection
Time frame: Up to 6 months
4 secondary outcomes
Type of the treatment (prophylaxis, on demand, surgery)
Time frame: Initial visit and 6 month f/u or at the end of the observation visit
Total consumption of FVIII
Time frame: Initial visit and 6 month f/u or at the end of the observation visit
Daily dosage/frequency of FVIII (if used for prophylaxis, on demand, surgery/peri-operatively)
Time frame: Initial visit, 6 month follow-up visit and 12 month follow-up visit
General assessment of therapy by physician by grading from 1 to 4: 1) excellent; 2) good; 3) sufficient; 4) insufficient
Time frame: 6 month f/u or at the end of observation visit
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 21 Aug 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
1 site in 1 country: 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 1 site in South Korea.
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 7 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 21 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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?
Safety variables will be summarized using descriptive statistics based on adverse events collection (time frame: Up to 6 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 21 Aug 2014.