Hemophilia A18706NCT02941783
Drug Use Investigation of Kovaltry in Hemophilia A Patients
An observational study of Hemophilia A, run by Bayer.
Trial summary
The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2016to 9 Sep 2025
- 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: Male and female hemophilia A patients are registered after the decision for treatment with Kovaltry has been made by the investigator. Both 'on demand' and 'prophylaxis' treatment are included.
Who may be able to join
- Male and female hemophilia A patients.
- Patients for whom the decision to treat with Kovaltry was determined prior to enrollment in the study.
Who cannot join
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A
About this study
Official title: Special Drug Investigation of Kovaltry in Hemophilia A Patients
The objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.
Read the detailed description
This company-sponsored study is a single-arm, prospective, observational study in hemophilia A patients administered Kovaltry. 200 cases will be planned to be registered as safety analysis set in three-year period. Within 200 cases, 50 cases less than 12 years old will be planned to be registered. Target population are all hemophilia A patients. The treatment should be performed based on the product label in Japan. The standard observation period is two years.
- Conditions
- Hemophilia A
- Being tested
- Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
- Keywords
- Kovaltry, hemophilia A, Japan, Post-marketing surveillance
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)Drug
Treatment parameters following the physician's decision based on the summary of product characteristics.
| Study group | Role | What they receive |
|---|---|---|
| BAY81-8973 | Hemophilia A patients who require Factor VIII replacement therapy Receives: Drug: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with adverse events as measure of safety and tolerability
Measured: Up to 2 years
Number of participants with serious adverse events as measure of safety and tolerability
Measured: Up to 2 years
Secondary outcomes (2)
Efficacy of controlling of bleeds
The efficacy is evaluated by the investigator and given on a four point scale: Excellent, Good, Moderate and Poor.
Measured: Up to 2 years
Number of annual bleeds
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study start30 Nov 2016
- Primary completion23 Mar 2022
- Study completion9 Sep 2025
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
- 230 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
- NCT02941783
- Sponsor's protocol ID
- 18706
- Acronym
- 18706
- Status last verified
- 22 Jul 2026
- First submitted
- 20 Oct 2016
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Investigation of Kovaltry in Hemophilia A Patients
- ClinicalTrials.gov ID
- NCT02941783
- Acronym / sponsor ID
- 18706 / 18706
- Conditions
- Hemophilia A
- Keywords
- Kovaltry, hemophilia A, Japan, Post-marketing surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 23 Mar 2022 (actual)
- Study completion
- 9 Sep 2025 (actual)
- First posted
- 21 Oct 2016 (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 objective in this study is collecting post-marketing information on the safety and efficacy of Kovaltry under the routine clinical practice.
Detailed description
This company-sponsored study is a single-arm, prospective, observational study in hemophilia A patients administered Kovaltry. 200 cases will be planned to be registered as safety analysis set in three-year period. Within 200 cases, 50 cases less than 12 years old will be planned to be registered. Target population are all hemophilia A patients. The treatment should be performed based on the product label in Japan. The standard observation period is two years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAY81-8973 | – | Drug: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)Hemophilia A patients who require Factor VIII replacement therapy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male and female hemophilia A patients are registered after the decision for treatment with Kovaltry has been made by the investigator. Both 'on demand' and 'prophylaxis' treatment are included.
Key inclusion criteria (2 listed)
- Male and female hemophilia A patients.
- Patients for whom the decision to treat with Kovaltry was determined prior to enrollment in the study.
Key exclusion criteria (2 listed)
- Patients participating in an investigational program with interventions outside of routine clinical practice.
- Patients with an additional diagnosis of any bleeding/coagulation disorder other than hemophilia A
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 |
|---|---|---|
| Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)Treatment parameters following the physician's decision based on the summary of product characteristics. | Drug | BAY81-8973 |
Primary outcome
Number of participants with adverse events as measure of safety and tolerability
Time frame: Up to 2 years
Number of participants with serious adverse events as measure of safety and tolerability
Time frame: Up to 2 years
2 secondary outcomes
Efficacy of controlling of bleeds
Time frame: Up to 2 years
Number of annual bleeds
Time frame: Up to 2 years
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 9 Sep 2026.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by Bayer.
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 2 inclusion and 2 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of participants with adverse events as measure of safety and tolerability (time frame: Up to 2 years). The study lists 2 primary outcomes in all. 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 9 Sep 2026.