CovidResearchTrials by Shray Alag

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FEIBAWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (0)

Name (Synonyms) Correlation

Correlated MeSH Terms (1)

Name (Synonyms) Correlation
D006467 Hemophilia A NIH 0.50

Correlated HPO Terms (1)

Name (Synonyms) Correlation
HP:0003125 Reduced factor VIII activity HPO 0.50

There is one clinical trial.

Clinical Trials

1 A Phase 3b/4, Prospective, Multicenter, Open-label, Randomized, Crossover Study of Tolerability and Safety of FEIBA Reconstituted in Regular or 50% Reduced Volume and of Faster Infusion Rates in Patients With Hemophilia A or B With Inhibitors

The purpose of this study is to: - 1. To evaluate the tolerability and safety of infusing reduced volume Factor Eight Inhibitor Bypassing Activity (FEIBA) at the standard infusion rate of 2 U/kg/min - 2. To evaluate the tolerability and safety of infusing reduced volume FEIBA at increased rates of 4 and 10 U/kg/min, in comparison to the standard rate of 2 U/kg/min at the regular volume

NCT02764489 Hemophilia A or B With Inhibitors Biological: FEIBA
MeSH:Hemophilia A
HPO:Reduced factor VIII activity

Primary Outcomes

Description: Number of participants with serious adverse events (SAEs) and non-SAEs will be assessed.

Measure: Number of Participants With Serious Adverse Events (SAEs) and Non-Serious Adverse Events

Time: Throughout the study period of approximately 13 months

Description: Number of participants with AEs particular to allergic-type hypersensitivity reactions will be assessed.

Measure: Number of Participants With Adverse Events (AEs) Related to Hypersensitivity Reactions

Time: Throughout the study period of approximately 13 months

Description: Number of participants with AEs particular to thromboembolic events will be assessed.

Measure: Number of Participants With Adverse Events (AEs) Related to Thromboembolic Events

Time: Throughout the study period of approximately 13 months

Description: Number of participants with AEs related to infusion site reactions will be assessed.

Measure: Number of Participants With Adverse Events (AEs) Related to Infusion Site Reactions

Time: Throughout the study period of approximately 13 months

Description: Number of participants with adverse events (AEs) leading to discontinuation will be assessed.

Measure: Number of Participants With Adverse Events (AEs) Leading to Discontinuation

Time: Throughout the study period of approximately 13 months

Description: Number of participants with AEs related to change in vital signs will be assessed. Vital signs will include body temperature (degree Celsius or degrees Fahrenheit [°C or °F]), respiratory rate (breaths/min), pulse rate (beats/min), and systolic and diastolic blood pressure (millimeter of mercury [mmHg]).

Measure: Number of Participants With Adverse Events (AEs) Related to Change in Vital Signs

Time: Throughout the study period of approximately 13 months

Description: Number of participants with AEs related to change in laboratory assessments will be assessed. Laboratory assessments include hematology, clinical chemistry, coagulation testing, serological testing, pregnancy testing, cluster differentiation 4 (CD4).

Measure: Number of Participants With Adverse Events (AEs) Related to Change in Laboratory Assessments

Time: Throughout the study period of approximately 13 months

Related HPO nodes (Using clinical trials)

HP:0003125: Reduced factor VIII activity
Genes 10
F8 F8 VWF MCFD2 LMAN1 F8 MCFD2 F8 LMAN1 VWF
Protein Mutations 1
G20210A
SNP 0