Hemophilia ANCT03248141
Understanding Hemophilia A and B Drug Dosage Administration Patterns
An observational study of Hemophilia A and Hemophilia B, run by Pfizer at 3 sites in United States.
Trial summary
Study Design A prospective observational, cross-sectional epidemiological study in U.S. site-based clinical practice settings. 30 sites will enroll approximately 300 patients Participating patients - or their caregiver in the case of patients under the age of 18 - will be consented to participate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia A, Hemophilia B
- What is being tested?
- Hemophilia B standard half-life, Hemophilia B extended half-life and Hemophilia A standard half-life
- How many people
- 11 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Sep 2017to 14 Mar 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 diagnosed with either hemophilia A or B who present for a routine Clinical visit will be asked to participate in the study by the treating physician at participating hemophilia treatment centers in the United States of America.
Who may be able to join
None listed.
Who cannot join
- Female with hemophilia A or B
- Mild Haemophilia A or B
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cook Children's Medical Center
Fort Worth, Texas, 76104
University of Florida College of Medicine
Gainesville, Florida, 32610
Alliance for Childhood Diseases, dba Hemophilia Treatment Center of Nevada
Las Vegas, Nevada, 89109
About this study
Official title: UNDERSTANDING HEMOPHILIA A AND B DRUG DOSAGE ADMINISTRATION PATTERNS
Study Design
A prospective observational, cross-sectional epidemiological study in U.S. site-based clinical practice settings.
30 sites will enroll approximately 300 patients
Participating patients - or their caregiver in the case of patients under the age of 18 - will be consented to participate.
Physicians complete a retrospective chart review on each enrolled patient.
Patients will complete a one-time study questionnaire.
Read the detailed description
Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on March 21, 2018. Subjects currently enrolled into the study have completed the study as per protocol. There were no safety concerns involved in the decision to stop enrollment.
- Conditions
- Hemophilia A, Hemophilia B
- Being tested
- Hemophilia B standard half-life, Hemophilia B extended half-life, Hemophilia A standard half-life, Hemophilia A extended half-life
- Keywords
- Hemophilia A Factor VIII, Hemophilia B Factor IX, Cross-sectional, Epidemiological, Clinical practice, United States
- Medical subject headings
- Hemophilia A, Hemophilia B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemophilia B standard half-lifeDrug
Benefix
Hemophilia B extended half-lifeDrug
Alprolix
Hemophilia A standard half-lifeDrug
Xyntha and other standard half-life agents
Hemophilia A extended half-lifeDrug
Eloctate and Adynovate
| Study group | Role | What they receive |
|---|---|---|
| Hemophilia B | real world administration patterns and resource utilization implications Receives: Drug: Hemophilia B standard half-life; Drug: Hemophilia B extended half-life | |
| Hemophilia A | real world administration patterns and resource utilization implications Receives: Drug: Hemophilia A standard half-life; Drug: Hemophilia A extended half-life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resource Utilization Pattern
Measured: From baseline up to end of study (6 months)
Dosing Pattern
Measured: From baseline up to end of study (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2017
- Study start1 Sep 2017
- Primary completion14 Mar 2018
- Study completion14 Mar 2018
Why it stopped: Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on March 21, 2018. See details in Description section.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by PfizerThe 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
- Other
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03248141
- Sponsor's protocol ID
- B1821056
- Other IDs
- HEMOBAFS
- Status last verified
- Feb 2019
- First submitted
- 31 May 2017
- Last updated
- 20 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UNDERSTANDING HEMOPHILIA A AND B DRUG DOSAGE ADMINISTRATION PATTERNS
- ClinicalTrials.gov ID
- NCT03248141
- Acronym / sponsor ID
- B1821056
- Conditions
- Hemophilia A, Hemophilia B
- Keywords
- Hemophilia A Factor VIII, Hemophilia B Factor IX, Cross-sectional, Epidemiological, Clinical practice, United States
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on March 21, 2018. See details in Description section.
- Enrolment
- 11 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 14 Mar 2018 (actual)
- Study completion
- 14 Mar 2018 (actual)
- First posted
- 14 Aug 2017 (actual)
- Results
- Posted 20 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Design
A prospective observational, cross-sectional epidemiological study in U.S. site-based clinical practice settings.
30 sites will enroll approximately 300 patients
Participating patients - or their caregiver in the case of patients under the age of 18 - will be consented to participate.
Physicians complete a retrospective chart review on each enrolled patient.
Patients will complete a one-time study questionnaire.
Detailed description
Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on March 21, 2018. Subjects currently enrolled into the study have completed the study as per protocol. There were no safety concerns involved in the decision to stop enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemophilia B | – | Drug: Hemophilia B standard half-life, Drug: Hemophilia B extended half-lifereal world administration patterns and resource utilization implications |
| Hemophilia A | – | Drug: Hemophilia A standard half-life, Drug: Hemophilia A extended half-lifereal world administration patterns and resource utilization implications |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with either hemophilia A or B who present for a routine Clinical visit will be asked to participate in the study by the treating physician at participating hemophilia treatment centers in the United States of America.
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Female with hemophilia A or B
- Mild Haemophilia A or B
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 |
|---|---|---|
| Hemophilia B standard half-lifeBenefix | Drug | Hemophilia B |
| Hemophilia B extended half-lifeAlprolix | Drug | Hemophilia B |
| Hemophilia A standard half-lifeXyntha and other standard half-life agents | Drug | Hemophilia A |
| Hemophilia A extended half-lifeEloctate and Adynovate | Drug | Hemophilia A |
Primary outcome
Resource Utilization Pattern
Time frame: From baseline up to end of study (6 months)
Dosing Pattern
Time frame: From baseline up to end of study (6 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Related trials for Hemophilia A
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A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A
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A Research Study Investigating Denecimig (Mim8) in Adults With Acquired Haemophilia A
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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
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RecruitingPhase 3
Open-Label Extension Study of Marstacimab in Hemophilia Participants With or Without Inhibitors
Hemophilia A, Hemophilia B
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.
Pfizer CT.gov Call Center study director
Pfizer
3 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 and Hemophilia B, run by Pfizer at 3 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?
The sponsor lists 0 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: stopped early, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 20 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Resource Utilization Pattern (time frame: From baseline up to end of study (6 months)). 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 20 May 2019; AzTrials last refreshed its copy on 2 Nov 2026.