Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation |
|---|
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0003125 | Reduced factor VIII activity HPO | 0.58 |
Navigate: Correlations HPO
There is one clinical trial.
The purpose of this study is to evaluate the safety and determine the dose of BAX 888.
Description: An AE is defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. A Serious adverse event (SAE) was an AE resulting in any of the following outcomes: death; life-threatening event; required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. AEs include both serious and non-serious adverse events including development of FVIII inhibitory antibodies, clinically significant changes in standard laboratory parameters, physical exam, and vital signs.
Measure: Number of Participants With BAX 888-Related Adverse Events (AEs) Time: From study drug administration to 3 YearsDescription: Change from baseline in circulating plasma FVIII activity level, based on one-stage clotting assay will be assessed.
Measure: Change from Baseline in Circulating Plasma FVIII Activity Level Time: Baseline, up to approximately 3 years per participantDescription: Change from baseline in circulating plasma FVIII antigen (protein) levels will be assessed.
Measure: Change from Baseline in Circulating Plasma FVIII Antigen Level Time: Baseline, up to approximately 3 years per participantDescription: Annualized bleed rate (ABR) in comparison to before gene transfer will be assessed. A bleed is defined as subjective or objective evidence of bleeding which may or may not require treatment with FVIII. Annualized bleed rate (ABR) was calculated as (number of bleeding episodes/observed treatment period in days)*365.25.
Measure: Annualized bleed rate (ABR) Time: Throughout the study period of approximately 3 years per participantDescription: The percentage of participants with a reduction in exogenous FVIII consumption 12 months post-infusion and 3 years post-infusion compared to the historical consumption (consumption of exogenous FVIII during the 12 month period prior to BAX 888 infusion).
Measure: Percentage of Participants with a Redaction Consumption of Exogenous Factor VIII (FVIII) Time: Historical data from 12 months prior to study enrollment; and 12 months post-infusion and 3 years post-infusionDescription: Number of participants develop inhibitory antibodies to FVIII will be assessed.
Measure: Number of Participants Develop Inhibitory Antibodies to FVIII Time: Throughout the study period of approximately 3 years per participantDescription: Number of participants develop total binding antibodies to FVIII (Immunoglobulin G [IgG] and Immunoglobulin M [IgM]) will be assessed.
Measure: Number of Participants Develop Total Binding Antibodies to FVIII Time: Throughout the study period of approximately 3 years per participantDescription: Number of participants with humoral (antibody-mediated) and cell-mediated immune response to adeno-associated virus (AAV8) (the vector) and FVIII proteins will be assessed.
Measure: Number of Participants With Humoral and Cell-Mediated Immune Response to AAV8 and Factor VIII (FVIII) Proteins Time: Throughout the study period of approximately 3 years per participantDescription: Surveillance of adeno-associated virus (AAV8) genome shedding in blood, saliva, semen, urine and stool will be assessed.
Measure: Surveillance of AAV8 Genome Shedding Time: Throughout the study period of approximately 3 years per participant,or until 2 consecutive measurements are negative, which ever is soonerAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports