Eligibility criteria
Condition
Hemophilia A, Hemophilia B
Sex
Females and Males
Age
0 +
Inclusion criteria
Show details
Exclusion criteria
Show details
- Female with hemophilia A or B
- Mild Haemophilia A or B
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Understanding Hemophilia A and B Drug Dosage Administration Patterns
NCT03248141
Last updated on October 11, 2019
About this Study
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.
NCT03248141
Pfizer
Active, not recruiting
Understanding Hemophilia A and B Drug Dosage Administration Patterns
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | Understanding Hemophilia A and B Drug Dosage Administration Patterns | ||||||
| Official Title | UNDERSTANDING HEMOPHILIA A AND B DRUG DOSAGE ADMINISTRATION PATTERNS | ||||||
| Brief 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. 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 Type | Observational | ||||||
| Study Design | Observational Model: Cohort Time Perspective: Other | ||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Non-Probability Sample | ||||||
| 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. | ||||||
| Condition |
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| Intervention |
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status | Terminated | ||||||
| Actual Enrollment | 11 | ||||||
| Original Estimated Enrollment | 300 | ||||||
| Actual Study Completion Date | March 14, 2018 | ||||||
| Actual Primary Completion Date | March 14, 2018 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria | Physician/Clinician Participants:
Patient Participants:
(If currently taking rurioctocog alfa or efraloctocog alfa, must have been switched from a standard half-life treatment and had been on that prior treatment for at least six months).
Exclusion criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03248141 | ||||||
| Other Study ID Numbers | B1821056 HEMOBAFS ( Other Identifier: Alias Study Number ) | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor | Pfizer | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | Pfizer | ||||||
| Verification Date | February 2019 | ||||||
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
BY PHONE
Pfizer Clinical Trials Contact Center
1-800-718-1021