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Study record managers: refer to the Data Element Definitions if submitting registration or information. Drug: Emicizumab Participants will receive emicizumab prophylaxis at the specified dose subcutaneously.

A clinical trial to evaluate prophylactic emicizumab versus no prophylaxis in hemophilia a participants without inhibitors (haven 3)

Upon implementation of protocol version 4, treatment duration will be extended. During this study prolongation, each participant may choose a preferred emicizumab dosing regimen among those permitted and continue on that dosing regimen until discontinuation from the study up to 6 years. A bleed is considered a "treated bleed" if it is directly followed i. Secondary Outcome Measures : Annualized Bleeding Rate ABR for All Bleeds [ Time Frame: From Baseline to at least 24 weeks ] The of all bleeds over the efficacy period is presented as an annualized bleeding rate ABR that was assessed using a NB regression model, which s for different follow-up times, with the patient's of bleeds as a function of randomization and the time that each patient stays in the study i.

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Annualized Bleeding Rate ABR for Treated t Bleeds [ Time Frame: From Baseline to at least 24 weeks ] The of treated t bleeds over the efficacy period is presented as an annualized bleeding rate ABR that was assessed using a NB regression model, which s for different follow-up times, with the patient's of bleeds as a function of randomization and the time that each patient stays in the study i. It is considered a "treated t bleed" if it is directly followed i.

Annualized Bleeding Rate ABR for Treated Spontaneous Bleeds [ Time Frame: From baseline to at least 24 weeks ] The of treated spontaneous bleeds over the efficacy period is presented as an annualized bleeding rate ABR that was assessed using a NB regression model, which s for different follow-up times, with the patient's of bleeds as a function of randomization and the time that each patient stays in the study i.

A "treated spontaneous bleed" is a spontaneous bleed that is directly followed i. Annualized Bleeding Rate ABR for Treated Target t Bleeds [ Time Frame: From Baseline to at least 24 weeks ] The of treated target t bleeds over the efficacy period is presented as an annualized bleeding rate ABR that was assessed using a NB regression model, which s for different follow-up times, with the patient's of bleeds as a function of randomization and the time that each patient stays in the study i.

A "target t bleed" is defined as a bleed reported as a t bleed into a target t, defined as at least 3 bleeds into the same t during the last 24 weeks prior to study entry. It is considered a "treated target t bleed" if it is directly followed i. The of treated bleeds over the efficacy period is presented as an ABR that was assessed using a NB regression model, which s for different follow-up times, with the of bleeds as a function of treatment and the time that each participant stays in the study i.

The model also includes a repeated statement to for intra-participant comparison.

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The of all bleeds over the efficacy period is presented as an ABR that was assessed using a NB regression model, which s for different follow-up times, with the participant's of bleeds as a function of treatment and the time that each participant stays in the study i. The questionnaire consists of items pertaining to 10 domains: physical health, sports and leisure, school and work, dealing with hemophilia, family planning, feeling, relationships, treatment, view of yourself, and outlook for the future.

The total score for each domain ranges from 0 to with lower scores reflective of better quality of life.

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Physical Health domain score is reported range 0 towith lower scores reflective of better physical health. The means were derived via an analysis of covariance ANCOVA model and have been adjusted for the following co-variates: baseline score, treatment group, and treatment by baseline interaction term.

Haem-A-QoL Total Score is the average of all domain scores and it ranges from 0 towith lower scores reflective of better quality of life.

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The VAS is deed to rate the participant's current health state on a scale from 0 towhere 0 represents the worst imaginable health state and represents the best imaginable health state. Responses from the five domains are used to calculate a single index utility score on a scale of 0 to 1, with higher scores reflective of better quality of life.

Items are rated with five respective response options: never, seldom, sometimes, often, and always.

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Haemo-QoL-SF total score range from 0 towhere lower scores reflect better health-related quality of life. At the clinical cut-off date for primary analysis 15 Sepdata was collected over a period of approximately 1 year. For adverse events that are not specifically listed in the WHO toxicity grading scale, a grade 3 adverse event is defined as: severe, marked limitation in activity, some assistance usually required, medical intervention or therapy required, hospitalization possible; and a grade 4 adverse event is defined as: life-threatening, extreme limitation in activity, ificant assistance required, ificant medical intervention or therapy required, hospitalization or hospice care probable.

A study to evaluate the efficacy, safety, and pharmacokinetics of prophylactic emicizumab versus no prophylaxis in hemophilia a participants with inhibitors (haven 1)

Vital s measurements consisted of heart and respiratory rate, temperature, and systolic and diastolic blood pressures, with an abnormal vital value being outside of the normal range. An abnormal vital result is reported as an adverse event if it meets any of the following criteria: is accompanied by clinical symptoms; in a change in study treatment e.

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An abnormal laboratory value is defined as a laboratory test result outside of the normal range for hematology or serum chemistries. It is reported as an adverse event if it meets any of the following criteria: is accompanied by clinical symptoms; in a change in study treatment e. An injection-related reaction that was localized was marked as a "local injection-site reaction.

A sample was considered positive for anti-emicizumab antibodies if the test result reached or exceeded a pre-determined threshold.

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A participant was considered to have developed de novo FVIII inhibitors if the inhibitor levels detected in a post-baseline sample reached or exceeded a pre-determined threshold. Trough Plasma Concentration Ctrough of Emicizumab [ Time Frame: Predose Hour 0 on every week during Weeksevery 2 weeks during Weeksevery 4 weeks during Weeksevery 8 weeks during Weeksevery 12 weeks thereafter up to the end of the study up to 2 years ] Plasma concentrations of emicizumab were analyzed using a validated Enzyme Linked Immunosorbent Assay ELISA.

The lower limit of quantitation was 0. Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.

For general information, Learn About Clinical Studies. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms. Save this study. Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U.

Federal Government. Read our disclaimer for details.

First Posted : November 14, Last Update Posted : August 10, Study Description. The study evaluates two prophylactic emicizumab regimens versus no prophylaxis in this population with emphasis on efficacy, safety, and pharmacokinetics. MedlinePlus related topics: Hemophilia. Drug Information available for: Emicizumab. FDA Resources. Arms and Interventions. Participants will receive emicizumab prophylaxis at the specified dose subcutaneously.

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Participants who european episodic treatment with FVIII prior to study entry will be randomized to continue episodic FVIII treatment when they start the trial; they will have the opportunity to switch to emicizumab prophylaxis after 24 weeks on-study. Outcome Measures. Primary Outcome Measures : Annualized Bleeding Rate ABR for Treated Bleeds [ Time Frame: From Baseline to at least 24 weeks ] The of treated bleeds over the efficacy period is presented as an annualized bleeding rate ABR that was assessed using a negative binomial NB regression model, which s for different follow-up times, with the of bleeds as a function of randomization and the time that each participant stays in the study i.

The of treated t bleeds over the efficacy period is presented as an annualized bleeding rate ABR that was assessed using a NB regression model, which s for different follow-up times, with the patient's of bleeds as a function of randomization and the time that each patient stays in the study i. The of treated spontaneous bleeds over the efficacy period is presented as an annualized bleeding rate ABR that was assessed using a NB regression model, which s for different follow-up times, with the patient's of dating as a function of randomization and the time that each patient stays in the study i.

The of treated target t bleeds over the efficacy period is presented as an annualized bleeding rate ABR that was assessed using a NB regression Haven, which s for different follow-up times, with the patient's of bleeds as a function of randomization and the time that each patient stays in the study Haven.

The Haem-A-QoL questionnaire has been developed and used in hemophilia A participants, assessing very specific aspects of european with hemophilia. EQ-5D-5L is a standardized, participant-rated questionnaire to assess health-related quality of life. The Haemo-QoL-SF contains 35 items, which cover nine domains considered relevant for the children's health-related quality of life physical health, feelings, view of yourself, family, friends, other people, sports and school, dealing with hemophilia and treatment.

The percentage of participants experiencing at least one adverse event, including all non-serious and serious adverse events, dating reported here. The percentage of participants with adverse events of changes from baseline in vital s is reported here. Post-baseline physical examination abnormalities that were not present at baseline or worsened were reported as adverse events. The percentage of participants with adverse events of abnormal laboratory values is reported here.

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Local adverse events that occurred within 24 hours after study drug administration and, in the investigator's opinion, were judged to be related to study drug injection, were captured as an "injection-site reaction" on the Adverse Event electronic Case Report Form eCRF. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

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Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information.

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Publications automatically indexed to this study by ClinicalTrials. N Engl J Med. Hemophilia A Emicizumab. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Hemophilia A. Drug: Emicizumab. Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :.