An observational study in Hemophilia A, sponsored by Hoffmann-La Roche. Completed at 35 sites in 12 countries. Per ClinicalTrials.gov, last updated 2017-05-30.
Sponsored by Hoffmann-La Roche · Observational
This non-interventional study will prospectively collect detailed, high-quality documentation of bleeds, HRQoL, and safety in patients with hemophilia A with or without FVIII inhibitors treated according to local routine clinical practice (receiving FVIII replacement or bypassing agents as either episodic or prophylactic treatment). Actual patients will be enrolled from routine clinical practice in this observational study.
866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.
This study's enrollment of 221 is above the median of 80 across 314 observational studies indexed under Hemophilia A.
Browse Hemophilia A studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with hemophilia A with or without inhibitors against FVIII under standard-of-care treatment are to be enrolled.
Exclusion Criteria:
Adults and adolescents with hemophilia A of any severity with the presence of FVIII inhibitors will be observed.
Drug: Bypassing Agents
Children with hemophilia A of any severity with the presence of FVIII inhibitors will be observed.
Adults and adolescents with severe hemophilia A without the presence of FVIII inhibitors will be observed.
Drug: FVIII Replacement
Episodic or prophylactic treatment with the use of bypassing agents must be documented for at least the last 6 months prior to the study. During the study, treatment for bleeds will be documented. The choice of coagulation product is at the discretion of the investigator according to local practice standards in this non-interventional study and there are no specific protocol-defined interventions.
Episodic or prophylactic treatment with the use of FVIII replacement must be documented for at least the last 6 months prior to the study. During the study, treatment for bleeds will be documented. The choice of coagulation product is at the discretion of the investigator according to local practice standards in this non-interventional study and there are no specific protocol-defined interventions.
Number of Bleeds
Time frame: Approximately 6 months (from Baseline until study completion)
European Quality of Life-5 Dimensions (EQ-5D-5L) Questionnaire Score Among Adult and Adolescent Patients
Time frame: Approximately 6 months (every 4 weeks from Baseline until study completion and on days that bleeds are reported)
Hemophilia A-Specific Quality of Life (Haem-A-QoL) Questionnaire Score Among Adult Patients
Time frame: Approximately 6 months (every 4 weeks from Baseline until study completion)
Hemophilia-Specific Quality of Life Short Form (Haemo-QoL-SF) Questionnaire Score
Time frame: Approximately 6 months (every 4 weeks from Baseline until study completion)
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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