Hemophilia ANCT03603275
Assessing Physician and Hemophilia A Patient Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry
An observational study of Hemophilia A, run by Bayer at 27 sites in United States.
Trial summary
This US study aims to assess hemophilia A patient characteristics and reasons for switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A patients who have switched from an existing therapy to Kovaltry or Jivi. Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- Hemophilia A
- What is being tested?
- New FVIII products
- How many people
- 3 participants
- Where
- 27 sitesUnited States
- Study dates
- 6 Aug 2018to 14 May 2020
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Previously treated hemophilia A patients enrolled into existing registry who have switched FVIII replacement treatment to Kovaltry or Jivi and provided consent to participate in the Bayer nested study ATHN's study with categorize selected subjects into two arms: * Arm A (Prospective): Patients who are switching factor replacement products and will be followed prospectively for 1 year post-switch * Arm B (Retrospective): Patients who have switched factor replacement products previously (within the past fifty weeks at the time of enrollments and will be followed prospectively until they reach a total of 52 weeks of observation. Historical data will be collected retrospectively for patients who switched prior to study entry.
Hemophilia A patients who have switched treatment to treatment with Kovaltry or Jivi within the past 50 weeks, who are enrolled the ATHN 2: Factor Switching Study, and who have consented to participate in the Kovaltry or Jivi specific module will be included in this study.
Trial locations and contacts
27 sites in 1 country.
27 sites in 1 country
United States27 sites
Univ of Michigan Hemophilia and Coagulation Disorders
Ann Arbor, Michigan, 48109
Emory / Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
University of Colorado Denver Hemophilia and Thrombosis Center
Aurora, Colorado, 80045
The Johns Hopkins University Hemophilia Treatment Center
Baltimore, Maryland, 21205
Boston Hemophilia Center at Children's Hospital of Boston/Brigham Women's
Boston, Massachusetts, 02115
UT Southwestern/Children's Health Dallas
Dallas, Texas, 75390
Michigan State University Center for Bleeding Disorders & Clotting Disorders
East Lansing, Michigan, 48824
Indiana Hemophilia and Thrombosis Center IHTC
Indianapolis, Indiana, 46260
Children's Mercy Hospital (Kansas City)
Kansas City, Missouri, 64108
University of California, San Diego
La Jolla, California, 92093
Dartmouth-Hitchcock Comprehensive Hemophilia and Thrombosis Center
Lebanon, New Hampshire, 03756
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Blood Center of Wisconsin, Inc. /Childrens Hosp of Wisconsin
Milwaukee, Wisconsin, 53226
Yale Hemophilia Treatment Center
New Haven, Connecticut, 06510
Louisiana Center for Bleeding and Clotting Disorders / Tulane
New Orleans, Louisiana, 70112
Weill Cornell Medicine
New York, New York, 10065
Bleeding and Clotting Disorders Institute
Peoria, Illinois, 61615
Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 01914
Penn Comprehensive Hemophilia and Thrombophilia Program / Hospital UPENN
Philadelphia, Pennsylvania, 19104
Hemophilia Center of Western Pennsylvania
Pittsburgh, Pennsylvania, 15213
Oregon Health & Science University
Portland, Oregon, 97239
Mary M. Gooley Hemophilia Center, Inc.
Rochester, New York, 14621
Maine Hemophilia and Thrombosis Center
Scarborough, Maine, 04074
BloodWorks (Puget Sound)
Seattle, Washington, 98104
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, 33701
St. Josephs Hemophilia Treatment Center
Tampa, Florida, 33607
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Assessing Hemophilia A Patient and Physician Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry
This US study aims to assess hemophilia A patient characteristics and reasons for switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A patients who have switched from an existing therapy to Kovaltry or Jivi. In doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia A and to more fully understand what drives patient switching from a patient perspective and a physician perspective.
Read the detailed description
This observational study consists of a patient and a physician survey. This survey will consist of questions developed by Bayer and submitted to the Steering Committee of the existing registry, ATHN-2. Once enrolled to participate in the ATHN-2 registry and provided consent to participate in the Bayer nested study, patients who have switched from another product to Kovaltry or Jivi within the past 50 weeks or at the time of enrollment will be prompted to answer the additional survey questions.
Conclusion of the ATHN-2 registry is scheduled for 2021. Once data is cleaned and locked by the registry, the data will be delivered to Bayer for conduct of our analyses.
- Conditions
- Hemophilia A
- Being tested
- New FVIII products
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New FVIII productsDrug
Kovaltry or Jivi prescribed by the treating Physician
| Study group | Role | What they receive |
|---|---|---|
| Patient/caregiver of Kovaltry or Jivi | Patients who are switching factor replacement products to Kovaltry or Jivi and patients who have switched factor replacement products to Kovaltry or Jivi previously Receives: Drug: New FVIII products | |
| Physician Group | Physicians participating in the study are associated with US hemophilia treatment centers that are affiliated with the ATHN hemophilia treatment center network |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Measured: Up to 4 years
Patient expectations of switching FVIII replacement therapy to Kovaltry or Jivi would affect lifestyle/quality of life using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Measured: Up to 4 years
Patient expectations when adjusting to the new product after switch using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Measured: Up to 4 years
Patient reported root of expectations using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Measured: Up to 4 years
Patient reported reasons that would deter them from switching FVIII replacement products using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Measured: Up to 4 years
Physicians reported discipline using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Measured: Up to 4 years
Physicians reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Measured: Up to 4 years
Dosing Regimen (pre/post-switch)
Data from consenting patients will be collected by ATHN
Measured: Up to 4 years
Physicians reported reason of newly selected dose/dosing interval using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Measured: Up to 4 years
Physicians reported rationale base for new dosing regimen selection using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Measured: Up to 4 years
Physicians reported communication about adjustment period when switching using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Measured: Up to 4 years
Physicians reported reasons that a provider would not encourage a patient to switch FVIII products using a Bayer designed survey
Data from consenting patients will be collected by ATHN
Measured: Up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2018
- Study start6 Aug 2018
- Primary completion14 May 2020
- Study completion14 May 2020
Why it stopped: Insufficient data
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
- Cross-sectional
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American Thrombosis and Hemostasis Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03603275
- Sponsor's protocol ID
- 19866
- Status last verified
- Aug 2022
- First submitted
- 20 Jul 2018
- Last updated
- 25 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Hemophilia A Patient and Physician Reasons and Expectations for Switching Treatment to Kovaltry & Jivi: A Nested Study Within an Existing Registry
- ClinicalTrials.gov ID
- NCT03603275
- Acronym / sponsor ID
- 19866
- Conditions
- Hemophilia A
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient data
- Enrolment
- 3 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- American Thrombosis and Hemostasis Network
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 14 May 2020 (actual)
- Study completion
- 14 May 2020 (actual)
- First posted
- 27 Jul 2018 (actual)
- 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.
This US study aims to assess hemophilia A patient characteristics and reasons for switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A patients who have switched from an existing therapy to Kovaltry or Jivi. In doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia A and to more fully understand what drives patient switching from a patient perspective and a physician perspective.
Detailed description
This observational study consists of a patient and a physician survey. This survey will consist of questions developed by Bayer and submitted to the Steering Committee of the existing registry, ATHN-2. Once enrolled to participate in the ATHN-2 registry and provided consent to participate in the Bayer nested study, patients who have switched from another product to Kovaltry or Jivi within the past 50 weeks or at the time of enrollment will be prompted to answer the additional survey questions.
Conclusion of the ATHN-2 registry is scheduled for 2021. Once data is cleaned and locked by the registry, the data will be delivered to Bayer for conduct of our analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient/caregiver of Kovaltry or Jivi | – | Drug: New FVIII productsPatients who are switching factor replacement products to Kovaltry or Jivi and patients who have switched factor replacement products to Kovaltry or Jivi previously |
| Physician Group | – | –Physicians participating in the study are associated with US hemophilia treatment centers that are affiliated with the ATHN hemophilia treatment center network |
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Previously treated hemophilia A patients enrolled into existing registry who have switched FVIII replacement treatment to Kovaltry or Jivi and provided consent to participate in the Bayer nested study ATHN's study with categorize selected subjects into two arms: * Arm A (Prospective): Patients who are switching factor replacement products and will be followed prospectively for 1 year post-switch * Arm B (Retrospective): Patients who have switched factor replacement products previously (within the past fifty weeks at the time of enrollments and will be followed prospectively until they reach a total of 52 weeks of observation. Historical data will be collected retrospectively for patients who switched prior to study entry.
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 |
|---|---|---|
| New FVIII productsKovaltry or Jivi prescribed by the treating Physician | Drug | Patient/caregiver of Kovaltry or Jivi |
Primary outcome
Patient reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey
Time frame: Up to 4 years
Data from consenting patients will be collected by ATHN
Patient expectations of switching FVIII replacement therapy to Kovaltry or Jivi would affect lifestyle/quality of life using a Bayer designed survey
Time frame: Up to 4 years
Data from consenting patients will be collected by ATHN
Patient expectations when adjusting to the new product after switch using a Bayer designed survey
Time frame: Up to 4 years
Data from consenting patients will be collected by ATHN
Patient reported root of expectations using a Bayer designed survey
Time frame: Up to 4 years
Data from consenting patients will be collected by ATHN
Patient reported reasons that would deter them from switching FVIII replacement products using a Bayer designed survey
Time frame: Up to 4 years
Data from consenting patients will be collected by ATHN
Physicians reported discipline using a Bayer designed survey
Time frame: Up to 4 years
Data from consenting patients will be collected by ATHN
Physicians reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey
Time frame: Up to 4 years
Data from consenting patients will be collected by ATHN
Dosing Regimen (pre/post-switch)
Time frame: Up to 4 years
Data from consenting patients will be collected by ATHN
Physicians reported reason of newly selected dose/dosing interval using a Bayer designed survey
Time frame: Up to 4 years
Data from consenting patients will be collected by ATHN
Physicians reported rationale base for new dosing regimen selection using a Bayer designed survey
Time frame: Up to 4 years
Data from consenting patients will be collected by ATHN
Physicians reported communication about adjustment period when switching using a Bayer designed survey
Time frame: Up to 4 years
Data from consenting patients will be collected by ATHN
Physicians reported reasons that a provider would not encourage a patient to switch FVIII products using a Bayer designed survey
Time frame: Up to 4 years
Data from consenting patients will be collected by ATHN
Results and safety
The study was stopped early (reason given: Insufficient data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
27 sites 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 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. 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 was stopped early (reason given: Insufficient data). Results are not available in the source record.
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?
Patient reported reasons for switching FVIII replacement treatment to Kovaltry or Jivi using a Bayer designed survey (time frame: Up to 4 years). The study lists 12 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 25 Aug 2022.