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Clinical Trials, and HPO
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| Name (Synonyms) | Correlation | |
|---|---|---|
| drug437 | BAX 888 Wiki | 0.58 |
| drug1485 | FEIBA Wiki | 0.58 |
| drug2658 | Observational Wiki | 0.29 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0003125 | Reduced factor VIII activity HPO | 1.00 |
| HP:0001367 | Abnormal joint morphology HPO | 0.41 |
Navigate: Correlations HPO
There are 3 clinical trials
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
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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsDescription: 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 monthsThe 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 soonerBackground. The recurrence of hemarthrosis in patients with congenital coagulopathies favors the development of a progressive, degenerative and intra-articular lesion (hemophilic arthropathy) that mainly affects the knees, ankles and elbows. Pain is one of the main clinical manifestations of hemophilic arthropathy. As a consequence of the COVID-19 pandemic, the Government of Spain, among others, established a total confinement for two months, in order to avoid contagion of the population Objective. To assess the effect of COVID-19 confinement on bleeding frequency, pain perception, and range of motion in patients with hemophilic arthropathy. Study design. Prospective observational study. Method. 27 patients with hemophilia A and B will be included in this study. Patients will be recruited from the Spanish Hemophilia Federation (Fishemo) specialized center for hemophilia patients. The dependent variables will be: the frequency of bleeding (through a self-report), the perception of pain (measured with the visual analog scale and a pressure algometer), the joint state (with the Hemophilia Joint Health Score), and the range of joint movement (measured with a goniometer). Two evaluations will be carried out: pre-treatment (carried out in the month of February, as a periodic evaluation) and post-treatment (at the end of the period of confinement in Spain). Expected results. The aim is to observe the sequelae caused by confinement and a sedentary lifestyle in patients with hemophilic arthropathy, through changes in joint status, pain and range of motion.
Description: The frequency of joint bleeding was assessed using a self-assessment log provided to patients at the beginning of confinement electronically. This registry included a monthly calendar where the patients included the date, symptoms and location of the hemarthrosis.
Measure: Change from baseline frequency of hemarthrosis after confinement period Time: Screening visit, within the first seven days after confinementDescription: Joint status was assessed with the Hemophilia Joint Health Score (HJHS) version 2.1. This tool, specific for hemophilia patients, evaluates joint deterioration in the ankle, knee and elbow joints. This scale measures 8 items: swelling, duration of swelling, atrophy and muscle strength, crepitus, mobility and joint pain. The scoring range for this additive scale is 0-20 points at each joint.
Measure: Change from baseline joint health after confinement period Time: Screening visit, within the first seven days after confinementDescription: Joint pain perception was measured with the visual analog scale. This scale has shown moderate reliability. The scoring range is from 0 to 10 points (from no pain to maximum perceived pain).
Measure: Change from baseline joint pain after confinement period Time: Screening visit, within the first seven days after confinementDescription: Range of motion was measured with a goniometer to assess flexion and extension of the elbow, knee, and ankle joints. This measuring instrument has shown good intra and inter-observer reliability in the joints evaluated. The measurement protocols described by Cleffken, Green and Gerhardt were used to measure mobility in the elbow, knee and ankle joints, respectively.
Measure: Change from baseline range of motion after confinement period Time: Screening visit, within the first seven days after confinementDescription: The pressure algometer measures the pressure, bilaterally, at which the patient perceives pressure pain on the evaluation point, as the pressure increases at a speed of approximately 50kPa / s. The unit of measurement is in Newton / cm2. The perception of joint pain in the elbow was measured on the lateral epicondyle, in the knee at a distance of 3 cm from the midpoint of the internal edge of the patella, and in the ankle it was measured in the ventral region of the lateral malleolus.
Measure: Change from baseline joint pain after confinement period Time: Screening visit, within the first seven days after confinementAlphabetical 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