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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1201 | Crisis management coaching Wiki | 0.58 |
| drug1759 | GSK3915393 Capsules Wiki | 0.58 |
| drug3061 | PRV-015 Wiki | 0.58 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1195 | Covid19 Wiki | 0.58 |
| drug732 | CALY-002 Wiki | 0.58 |
| drug1790 | Gluten Wiki | 0.58 |
| drug1760 | GSK3915393 Solution for Infusion Wiki | 0.58 |
| drug1198 | Covigenix VAX-001 placebo Wiki | 0.58 |
| drug1197 | Covigenix VAX-001 Wiki | 0.58 |
| drug3240 | Placebo capsules Wiki | 0.41 |
| drug3195 | Placebo Wiki | 0.05 |
Navigate: Correlations HPO
There are 3 clinical trials
This study will evaluate the efficacy and safety of PRV-015 in adult patients with non-responsive celiac disease (NRCD) who are on a gluten-free diet (GFD).
Description: Celiac Disease Patient-Reported Outcome (CeD PRO)
Measure: Efficacy of PRV-015 in attenuating the symptoms of celiac disease in adult patients with NRCD as measured by the Celiac Disease Patient-Reported Outcome (CeD PRO) questionnaire Time: 24 weeksDescription: Intraepithelial lymphocyte (IEL) density
Measure: Effect of treatment with PRV-015 on other measures of disease activity Time: 24 weeksDescription: Safety endpoint
Measure: Incidence of treatment-emergent adverse events (TEAEs) Time: 28 weeksDescription: Characterize the pharmacokinetics (PK) of PRV-015
Measure: Serum trough concentrations of PRV-015 at scheduled visits Time: 28 weeksDescription: Immunogenicity endpoint
Measure: Incidence of anti-PRV-015 antibodies Time: 28 weeksThis is a single and multiple ascending study to characterize the safety, PK, PD and clinical effect in healthy volunteers and participants with Celiac Disease and Eosinophilic Esophagitis.
Celiac disease is a common T cell-mediated disorder triggered by dietary gluten with a worldwide prevalence estimated at one percent. GSK3915393 is being developed as an orally administered inhibitor of the enzyme transglutaminase 2 (TG2) for the treatment of participants with CeD. This study is the first time into human study (FTIH) for GSK3915393.
Description: AEs, SAEs and treatment related AEs will be collected.
Measure: Part A: Number of participants with adverse events (AEs), serious AEs (SAEs), and treatment related AEs following oral dosing Time: Up to Week 11Description: AEs, SAEs and treatment related AEs will be collected.
Measure: Part B: Number of participants with AEs, SAEs and treatment related AEs Time: Up to Week 4Description: AEs, SAEs and treatment related AEs will be collected.
Measure: Part C: Number of participants with AEs, SAEs and treatment related AEs Time: Up to Week 4Description: Participants with clinically significant changes in physical examination will be assessed.
Measure: Part A: Number of participants with clinically significant changes in physical examination following oral dosing Time: Up to Week 11Description: Participants with clinically significant changes in physical examination will be assessed.
Measure: Part B: Number of participants with clinically significant changes in physical examination Time: Up to Week 4Description: Participants with clinically significant changes in physical examination will be assessed.
Measure: Part C: Number of participants with clinically significant changes in physical examination Time: Up to Week 4Description: Participants with clinically significant changes in vital signs will be assessed.
Measure: Part A: Number of participants with clinically significant changes in vital signs following oral dosing Time: Up to Week 11Description: Participants with clinically significant changes in vital signs will be assessed.
Measure: Part B: Number of participants with clinically significant changes in vital signs Time: Up to Week 4Description: Participants with clinically significant changes in vital signs will be assessed.
Measure: Part C: Number of participants with clinically significant changes in vital signs Time: Up to Week 4Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Part A: Number of participants with clinically significant changes in hematology parameters following oral dosing Time: Up to Week 11Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Part B: Number of participants with clinically significant changes in hematology parameters Time: Up to Week 4Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Part C: Number of participants with clinically significant changes in hematology parameters Time: Up to Week 4Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Part A: Number of participants with clinically significant changes in clinical chemistry parameters following oral dosing Time: Up to Week 11Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Part B: Number of participants with clinically significant changes in clinical chemistry parameters Time: Up to Week 4Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Part C: Number of participants with clinically significant changes in clinical chemistry parameters Time: Up to Week 4Description: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Part A: Number of participants with clinically significant changes in urinalysis parameters following oral dosing Time: Up to Week 11Description: Urine samples will be collected for the assessment of urinalysis parameters
Measure: Part B: Number of participants with clinically significant changes in urinalysis parameters Time: Up to Week 4Description: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Part C: Number of participants with clinically significant changes in urinalysis parameters Time: Up to Week 4Description: Participants with clinically significant changes in electrocardiogram findings will be assessed.
Measure: Part A: Number of participants with clinically significant changes in electrocardiogram findings following oral dosing Time: Up to Week 11Description: Participants with clinically significant changes in electrocardiogram findings will be assessed.
Measure: Part B: Number of participants with clinically significant changes in electrocardiogram findings Time: Up to Week 4Description: Participants with clinically significant changes in electrocardiogram findings will be assessed.
Measure: Part C: Number of participants with clinically significant changes in electrocardiogram findings Time: Up to Week 4Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part A: Maximum observed plasma drug concentration (Cmax) following single oral dose of GSK3915393 Time: Pre-dose to Day 2 in Treatment Periods 1, 2, 4 and 5 (Each period is 4 days)Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part A: Cmax following single intravenous (IV) dose of GSK3915393 Time: Pre-dose to Day 1 in Treatment Period 3 (Each period is 4 days)Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part A: Time to maximum observed plasma concentration (Tmax) following single oral dose of GSK3915393 Time: Pre-dose to Day 2 in Treatment Periods 1, 2, 4 and 5 (Each period is 4 days)Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part A: Tmax following single IV dose of GSK3915393 Time: Pre-dose to Day 1 in Treatment Period 3 (Each period is 4 days)Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part A: Area under the plasma concentration time curve from time zero to last quantifiable concentration (AUC[0 to t]) following single oral dose of GSK3915393 Time: Pre-dose to Day 2 in Treatment Periods 1, 2, 4 and 5 (Each period is 4 days)Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part A: AUC(0 to t) following single IV dose of GSK3915393 Time: Pre-dose to Day 1 in Treatment Period 3 (Each period is 4 days)Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part A: AUC from time zero to infinity (AUC[0 to inf]) following single oral dose of GSK3915393 Time: Pre-dose to Day 2 in Treatment Periods 1, 2, 4 and 5 (Each period is 4 days)Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part A: AUC(0 to inf) following single IV dose of GSK3915393 Time: Pre-dose to Day 1 in Treatment Period 3 (Each period is 4 days)Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part A: Apparent terminal phase half-life (T1/2) following single oral dose of GSK3915393 Time: Pre-dose to Day 2 in Treatment Periods 1, 2, 4 and 5 (Each period is 4 days)Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part A: T1/2 following single IV dose of GSK3915393 Time: Pre-dose to Day 1 in Treatment Period 3 (Each period is 4 days)Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part A: Clearance (CL) following single IV dose of GSK3915393 Time: Pre-dose to Day 1 in Treatment Period 3 (Each period is 4 days)Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part A: Volume of distribution (Vd) following single IV dose of GSK3915393 Time: Pre-dose to Day 1 in Treatment Period 3 (Each period is 4 days)Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part A: Absolute bioavailability (F) following single oral dose of GSK3915393 Time: Pre-dose to Day 2 in Treatment Periods 1, 2, 4 and 5 (Each period is 4 days)Description: AEs, SAEs and treatment related AEs will be collected.
Measure: Part A: Number of participants with AEs, SAEs and treatment related AEs following IV dosing Time: Up to Week 11Description: Participants with clinically significant changes in physical examination will be assessed.
Measure: Part A: Number of participants with clinically significant changes in physical examination following IV dosing Time: Up to Week 11Description: Participants with clinically significant changes in vital signs will be assessed.
Measure: Part A: Number of participants with clinically significant changes in vital signs following IV dosing Time: Up to Week 11Description: Blood samples will be collected for the assessment of hematology parameters.
Measure: Part A: Number of participants with clinically significant changes in hematology parameters following IV dosing Time: Up to Week 11Description: Blood samples will be collected for the assessment of clinical chemistry parameters.
Measure: Part A: Number of participants with clinically significant changes in clinical chemistry parameters following IV dosing Time: Up to Week 11Description: Urine samples will be collected for the assessment of urinalysis parameters.
Measure: Part A: Number of participants with clinically significant changes in urinalysis parameters following IV dosing Time: Up to Week 11Description: Participants with clinically significant changes in electrocardiogram findings will be assessed.
Measure: Part A: Number of participants with clinically significant changes in electrocardiogram findings following IV dosing Time: Up to Week 11Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part B: Cmax following first dose of GSK3915393 Time: Pre-dose and up to 10 hours post-dose on Days 1, 3, 5, 7 and 15Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part B: Cmax following second dose of GSK3915393 Time: 10 hours to 24 hours post first dose on Days 1 and 14Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part B: Tmax following first dose of GSK3915393 Time: Pre-dose and up to 10 hours post-dose on Days 1, 3, 5, 7 and 15Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part B: Tmax following second dose of GSK3915393 Time: 10 hours to 24 hours post first dose on Days 1 and 14Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part B: AUC(0-t) following first dose of GSK3915393 Time: Pre-dose and up to 10 hours post-dose on Days 1, 3, 5, 7 and 15Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part B: AUC(0-t) following second dose of GSK3915393 Time: 10 hours to 24 hours post first dose on Days 1 and 14Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part B: AUC over the dosing interval (AUC[0 to tau]) following first dose of GSK3915393 Time: Pre-dose and up to 10 hours post-dose on Days 1, 3, 5, 7 and 15Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393
Measure: Part B:AUC(0 to tau) following second dose of GSK3915393 Time: 10 hours to 24 hours post first dose on Days 1 and 14Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part B: Trough concentration (Ctrough) following repeat dose of GSK3915393 Time: Pre first dose on Days 2, 3, 5, 7, 14Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part C: Cmax following single dose of GSK3915393 Time: Pre-dose to 10 hours post first dose on Day 1Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part C: Tmax following single dose of GSK3915393 Time: Pre-dose to 10 hours post first dose on Day 1Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part C: AUC(0-t) following single dose of GSK3915393 Time: Pre-dose to 10 hours post first dose on Day 1Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part C: AUC(0-inf) following single dose of GSK3915393 Time: Pre-dose to 10 hours post first dose on Day 1Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part C: T1/2 following single dose of GSK3915393 Time: Pre-dose to 10 hours post first dose on Day 1Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part C: Cmax following repeat dose of GSK3915393 Time: Pre-dose to 10 hours post first dose on Days 7, 8, 10, 14Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part C: Tmax following repeat dose of GSK3915393 Time: Pre-dose to 10 hours post first dose on Days 7, 8, 10, 14Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part C: AUC(0-t) following repeat dose of GSK3915393 Time: Pre-dose to 10 hours post first dose on Days 7, 8, 10, 14Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part C: AUC(0-tau) following repeat dose of GSK3915393 Time: Pre-dose to 10 hours post first dose on Days 7, 8, 10, 14Description: Blood samples will be collected at the indicated time points for pharmacokinetic analysis of GSK3915393.
Measure: Part C: Ctrough following repeat dose of GSK3915393 Time: Pre first dose on Days 2, 7, 8, 10, 14Description: Blood samples will be collected at indicated time points for assessment of IL-2. It is the maximum change in IL2 from pre to post gluten challenge on Day 8.
Measure: Part C: Maximum pre to post gluten challenge changes in Interleukin-2 (IL-2) on Day 8 Time: Immediately pre-dose and up to 6 hours post gluten ingestion on Day 8Alphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on December 13, 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