Hemophilia A, CongenitalTAURUSNCT02830477
Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis
An observational study of Hemophilia A, Congenital, run by Bayer at 25 sites in 13 countries.
Trial summary
The primary objective of this study is to investigate weekly prophylaxis dosing regimens used in standard clinical practice. In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose \& dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hemophilia A, Congenital
- What is being tested?
- Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973
- Type of treatment
- Injection or infusion
- How many people
- 313 participants
- Where
- 25 sitesin 13 countries
- Study dates
- 14 Oct 2016to 1 Mar 2021
- 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: Previously treated male patients with moderate to severe (≤ 5% FVIII:C) hemophilia A, with ≥ 50 exposure days (EDs) to any FVIII product and with or without history of inhibitors who have been prescribed KOVALTRY for a medically appropriate use will be eligible to be included into this study.
Who may be able to join
- Male patients diagnosed with moderate to severe hemophilia A (≤ 5% FVIII:C (Factor VIII Coagulant activity))
- Any age
- ≥ 50 exposure days (EDs) to any FVIII product
- Patients with or without history of inhibitors
- Patient with previous history of inhibitors, with at least 2 consecutive negative inhibitor tests and on standard prophylaxis therapy for at least 1 year prior to study entry
- No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor
Show all 10Show fewer
- Evidence of FVIII inhibitor as measured by the Nijmegen-modified Bethesda assay [<0.6 Bethesda units (BU/mL)] or Bethesda assay [< 1.0 BU/mL] in 2 on consecutives samples
- Documented or clinical suspicion of shortened FVIII half-life (< 6 hrs)
- Currently on or plan to start prophylaxis therapy with KOVALTRY
- Written informed consent
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
- Patients on Immune Tolerance Induction (ITI) treatment at the time of enrollment
Trial locations and contacts
25 sites in 13 countries.
25 sites in 13 countries
United States13 sites
University of Colorado Hemophilia and Thrombosis Center
Aurora, Colorado
Hemophilia Center of Western New York
Buffalo, New York
Henry Ford Hospital Adult Hemophilia and Thrombosis Treatment Center
Detroit, Michigan
University of Florida Health Cancer Center
Gainesville, Florida
East Carolina University - Brody School of Medicine
Greenville, North Carolina
Nemours Children's Clinic - Division of Pediatric Hematology/Oncology - Jacksonsville
Jacksonville, Florida
Comprehensive Center for Bleeding Disorders / Blood Center of Wisconsin
Milwaukee, Wisconsin
Children's Rehabilitation Services/ University of South Alabama
Mobile, Alabama
Children's Hospital at OU Medical Center
Oklahoma City, Oklahoma
Nemours Children's Clinic - Pensacola
Pensacola, Florida
Intermountain Hemophilia & Thrombosis Center
Salt Lake City, Utah
Washington University Center for Bleeding and Blood Clotting Disorders
St Louis, Missouri
Wake Forest University School of Medicine
Winston-Salem, North Carolina
About this study
Official title: A Multinational Phase IV Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis
The primary objective of this study is to investigate weekly prophylaxis dosing regimens used in standard clinical practice.
In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose \& dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data (if performed), KOVALTRY consumption, as well as safety data.
Read the detailed description
Open label, prospective, non-interventional, single arm study in patients receiving KOVALTRY as prophylaxis therapy.
- Conditions
- Hemophilia A, Congenital
- Being tested
- Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973
- Keywords
- Previously treated patients
- 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], BAY81-8973Biological
unmodified, full length recombinant FVIII
| Study group | Role | What they receive |
|---|---|---|
| BAY81-8973 | Previously treated patients receiving IV infusion of KOVALTRY for routine prophylaxis Receives: Biological: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients on 2x and 3x weekly prophylaxis at end of observation period
Measured: Up to 2 years
Secondary outcomes (11)
Annualized composite number of reported bleeds (total, spontaneous, joint and trauma)
Measured: Up to 2 years
Proportion of patients in predefined prophylaxis regimen per age group and per country
Age group: 0 to <6, ≥6 to <12, ≥12 to <18, 18 and above
Weekly prophylaxis dosing regimens:
- 2 injections a week
- 3 injections a week
- Injected on every other day
Measured: At the end of observational period, up to 2 years
Physician decision determinants of prophylaxis regimen
Age i.v. access Current treatment regimen Bleeding history with current treatment regimen Prior history of life threatening bleed Number of target joints Pharmacokinetic data Adherence/Compliance history Activity level Patient/caregiver preference Caregiver support Insurance coverage (US) Institution guidelines Country guidelines Other
Measured: At baseline
Change from baseline to one year and two years in treatment satisfaction (Hemo-SAT)
Hemo-SAT - Hemophilia treatment satisfaction questionnaire
Measured: At baseline, 1 year and end of observational period, up to 2 years
Change from baseline to six months, one year and two years in Validated Hemophilia Regimen Treatment Adherence Scale-Prophylaxis (VERITAS-PRO)
VERITAS - Validated Hemophilia Regimen Treatment Adherence Scale-Prophylaxis
Measured: At baseline, 6 months and end of observational period, up to 2 years
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to 2 years
Type of data relating to KOVALTRY PK
Pharmacokinectic (PK) parameters
- Area under the curve (AUC)
- Clearance (Cl)
- Half-life
- FVIII trough
- FVIII peak levels
- In-vivo recovery
Measured: At routine visits, up to 2 years
The total annualized factor consumption (injections)
Measured: Up to 2 years
Change in prophylaxis dosing frequency (study start to end of observation period)
Measured: At baseline and end of observation period, up to 2 years
Reasons for selection of initial dose / dosing frequency of Kovaltry (study start to end of observation period)
Measured: At baseline and end of observation period, up to 2 years
Number of KOVALTRY PK assessments performed
Measured: At routine visits, 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 posted13 Jul 2016 (estimated)
- Study start14 Oct 2016
- Primary completion1 Dec 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemophilia A, CongenitalStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 313 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
- NCT02830477
- Sponsor's protocol ID
- 18559
- Other IDs
- KV1601
- Acronym
- TAURUS
- Status last verified
- Nov 2023
- First submitted
- 29 Jun 2016
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Santoro C, Fuh B, Le PQ, Maes P, Berrueco R, Mingot-Castellano EM, von Mackensen S, Tueckmantel C, Cabre-Marquez JF, Wang M. Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81-8973): Final results of the global real-world study, TAURUS. Eur J Haematol. 2023 Jan;110(1):77-87. doi: 10.1111/ejh.13876. Epub 2022 Oct 17.
PubMed 36192847
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multinational Phase IV Study Evaluating "Real World" Treatment Pattern in Previously Treated Hemophilia A Patients Receiving KOVALTRY (Octocog Alfa) for Routine Prophylaxis
- ClinicalTrials.gov ID
- NCT02830477
- Acronym / sponsor ID
- TAURUS / 18559
- Conditions
- Hemophilia A, Congenital
- Keywords
- Previously treated patients
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 313 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2016 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 13 Jul 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 primary objective of this study is to investigate weekly prophylaxis dosing regimens used in standard clinical practice.
In addition the study will capture reported bleed rate, pattern of change in KOVALTRY prophylaxis dose \& dosing frequency, reason for choice of treatment regimen, FVIII product switch pattern, patient treatment satisfaction and adherence, KOVALTRY pharmacokinetic data (if performed), KOVALTRY consumption, as well as safety data.
Detailed description
Open label, prospective, non-interventional, single arm study in patients receiving KOVALTRY as prophylaxis therapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BAY81-8973 | – | Biological: Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973Previously treated patients receiving IV infusion of KOVALTRY for routine prophylaxis |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Previously treated male patients with moderate to severe (≤ 5% FVIII:C) hemophilia A, with ≥ 50 exposure days (EDs) to any FVIII product and with or without history of inhibitors who have been prescribed KOVALTRY for a medically appropriate use will be eligible to be included into this study.
Key inclusion criteria (10 listed)
- Male patients diagnosed with moderate to severe hemophilia A (≤ 5% FVIII:C (Factor VIII Coagulant activity))
- Any age
- ≥ 50 exposure days (EDs) to any FVIII product
- Patients with or without history of inhibitors
- Currently on or plan to start prophylaxis therapy with KOVALTRY
Key exclusion criteria (3 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
- Patients on Immune Tolerance Induction (ITI) treatment at the time of enrollment
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], BAY81-8973unmodified, full length recombinant FVIII | Biological | BAY81-8973 |
Primary outcome
Proportion of patients on 2x and 3x weekly prophylaxis at end of observation period
Time frame: Up to 2 years
11 secondary outcomes
Annualized composite number of reported bleeds (total, spontaneous, joint and trauma)
Time frame: Up to 2 years
Proportion of patients in predefined prophylaxis regimen per age group and per country
Time frame: At the end of observational period, up to 2 years
Physician decision determinants of prophylaxis regimen
Time frame: At baseline
Change from baseline to one year and two years in treatment satisfaction (Hemo-SAT)
Time frame: At baseline, 1 year and end of observational period, up to 2 years
Change from baseline to six months, one year and two years in Validated Hemophilia Regimen Treatment Adherence Scale-Prophylaxis (VERITAS-PRO)
Time frame: At baseline, 6 months and end of observational period, up to 2 years
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 2 years
Type of data relating to KOVALTRY PK
Time frame: At routine visits, up to 2 years
The total annualized factor consumption (injections)
Time frame: Up to 2 years
Change in prophylaxis dosing frequency (study start to end of observation period)
Time frame: At baseline and end of observation period, up to 2 years
Reasons for selection of initial dose / dosing frequency of Kovaltry (study start to end of observation period)
Time frame: At baseline and end of observation period, up to 2 years
Number of KOVALTRY PK assessments performed
Time frame: At routine visits, 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 7 Nov 2023.
- Results publication: PubMed 36192847Santoro C, Fuh B, Le PQ, Maes P, Berrueco R, Mingot-Castellano EM, von Mackensen S, Tueckmantel C, Cabre-Marquez JF, Wang M. Efficacy and safety in patients with haemophilia A switching to octocog alfa (BAY 81-8973): Final results of the global real-world study, TAURUS. Eur J Haematol. 2023 Jan;110(1):77-87. doi: 10.1111/ejh.13876. Epub 2022 Oct 17.
Related trials for Hemophilia A, Congenital
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Fitusiran Prophylaxis in Male Participants Aged 1 to Less Than 12 Years With Hemophilia A or B
Hemophilia
Not yet recruitingObservational study
A Study to Describe Patient REal-world FitusiRan ExpeRience
Hemophilia A or B
RecruitingObservational study
An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
Hemophilia A
RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Hemophilia A, Hemophilia B
RecruitingPhase 3
A Clinical Study to Evaluate the Effects of NXT007 Compared to Factor VIII Prophylaxis in Participants With Hemophilia A
Hemophilia A
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
25 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, Congenital, run by Bayer at 25 sites in 13 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 10 inclusion and 3 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 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Belgium, Canada, Colombia, France and 8 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?
Proportion of patients on 2x and 3x weekly prophylaxis at end of observation period (time frame: Up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02830477, which also lists 1 linked publication.
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 7 Nov 2023.