Clinical TrialID 5398
Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects
NCT03306589
Arthritis, Rheumatoid
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5398
- Evidence Id
- 5398
- Core Evidence Id
- 5398
- Source Clinical Trial Id
- 5383
- Herb2 Clinical Trial Id
- HBCT005383
- Nct Id
- NCT03306589
- Title
- Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects
- Status
- Completed
- Phase
- Phase 1
- Study Result
- Yes
- Study Condition
- Arthritis, Rheumatoid
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: DIAGNOSTIC
- Intervention
- BIOLOGICAL: Cantharidin|BIOLOGICAL: Lipopolysaccharide|BIOLOGICAL: Granulocyte-Macrophage Colony-Stimulating Factor|DRUG: Saline Solution
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Diagnostic
- Gender
- Male
- Age
- Adult
- Enrollment
- 12
- Outcome Measure
- Part 1: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: Tumor Necrosis Factor (TNF) Alpha and Interleukin (IL) 6 for LPS Arm, Blood samples were collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Each session was for three days. NA indicates that data was not available as standard deviation could not be calculated for a single participant. All participants who were randomized to receive the treatment (LPS or GM-CSF challenge) and received one dose of challenge agent were included in Safety Population., Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 2 hours 40 minutes,5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Part 1: Change From Baseline in Primary Soluble Inflammatory Mediators : Urinary Tetranor Prostaglandin D Metabolite (PGDM) LPS Arm, The post-challenge urine samples were collected during session 2 after LPS challenge. In session 2, participants were encouraged to pass urine immediately before LPS challenge dose and urine voids were collected from after LPS until 12 hours post-LPS and the time of the urine collection were recorded as post-challenge 1 to 11. These samples were collected for measurement of tetranor-PGDM. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. The data for normalized Tetranor PGDM was normalized by (Tetranor PGDM \[pg/mL\] divided by Creatinine \[milligram per deciliter\]) multiplied by 100. NA indicates that data was not available as standard deviation could not be calculated for a single participant., Baseline, Session 2 Day 1|Part 2: Change From Baseline Primary Soluble Inflammatory Mediators in Blood: TNF Alpha and IL 6: LPS Arm, Blood samples were planned to be collected at indicated timepoints for the analysis of primary soluble inflammatory mediators like TNF-alpha and IL-6 in blood. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved., Baseline, Session 2: -5, 10, 25, 40 minutes, 1 hour 10 minutes, 1 hour 40 minutes, 5 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Part 2: Change From Baseline Primary Soluble Inflammatory Mediators : Urinary Tetranor PGDM: LPS Arm, Urine samples were planned to be collected for analysis. Latest pre-challenge LPS assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved., Baseline, Session 2 Day 1|Part 1: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF, Blood samples were collected at indicated time-points for analysis of white blood cells. Latest pre-challenge GM-CSF assessment with a non-missing value, including those from unscheduled visits was considered as Baseline. Change from Baseline was calculated as the value at specified visit minus the Baseline value., Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3|Part 2: Change From Baseline in White Blood Cell Numbers in Blood: GM-CSF, Blood samples were planned to be collected at indicated time-points for analysis of white blood cells. Baseline value is Session 2 Day 1. Change from Baseline was calculated as the value at specified visit minus the Baseline value. Part 2 of the study was not conducted as agreed criteria for Interim analysis was achieved., Baseline, Session 2: 40 minutes, 2 hours 40 minutes, 5 hours 40 minutes, 9 hours 40 minutes on Day 1. Pre-fluid sample on Day 2 and Day 3
- Sponsor Collaborator
- GlaxoSmithKline
- Funded By
- INDUSTRY
- Location
- GSK Investigational Site, Cambridge, CB2 2GG, United Kingdom
- Other Id
- 207654
- Start Date
- 2017-08-11
- Primary Completion Date
- 2018-01-03
- Completion Date
- 2018-06-20
- First Posted
- 2017-10-11
- Results First Posted
- 2019-08-08
- Last Update Posted
- 2019-08-08
- Study Document
- Study Protocol, https://cdn.clinicaltrials.gov/large-docs/89/NCT03306589/Prot_000.pdf|Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/89/NCT03306589/SAP_001.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT03306589
- Title Cn
- Title En
- Lipopolysaccharide (LPS) or Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) Challenge Study on Healthy Subjects
- Bilingual Status
- semi_complete