← Trials/Trial dossier/NCT01573806

PEPS

WithdrawnPhase 1, PHASE2

Pharmacology of Exenatide in Pediatric Sepsis

Phase 1-2 Study of the Pharmacology of Exenatide in Pediatric Sepsis

Lead sponsor

Seattle Children's Hospital

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

—

actual

Study population

—

Key I/E criterion

—

Primary endpoints

•Treatment-emergent AEs (any)•Exenatide pharmacokinetics

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01573806

Org study IDPEPS-SCH-001

Timeline

Milestones

Study first posted2012-04-10estimated

Last update posted2017-10-05actual

Study start2012-10 (month precision)

Primary completion2014-10estimated (month precision)

Study completion2014-10estimated (month precision)

Assets

Investigational agents

Exenatide

Eligibility

Who can enroll

Minimum age1 Month

Maximum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age 44 weeks estimated gestational age to 18 years AND

•Admitted to the PICU for the sepsis event AND

•Vascular catheter capable of providing serial blood samples in place AND

•Diagnosis of septic shock = sepsis with cardiovascular organ dysfunction AND

•Parents speak English or Spanish

Exclusion criteria

•Greater than 12 hours from admission to PICU to enrollment OR

•Chronic or acute dialytic therapy, history of renal impairment or renal transplantation OR

•History of pancreatitis OR

•History of hypersensitivity to Byetta OR

•History of severe gastrointestinal disease or gastroparesis OR

•History of diabetes mellitus, type I or type II OR

•History of insulin, sulfonyl urea drugs, or coumarin use OR

•History of hypoglycemia OR

•History of active pregnancy (effect of exenatide on the fetus is unknown) OR

•Inability to collect serial blood samples OR

•Previously enrolled in the PEPS study OR

•Lack of commitment to aggressive sepsis therapy OR

•Expectation to succumb from the sepsis event OR

•Patient is a foster child and/or ward of the state OR

•Sepsis event associated with a PICU-acquired nosocomial infection OR

•Patient is enrolled in another interventional investigation that might obscure the potential effects of exenatide dosing.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Safety / tolerability / PK

Glycemic / diabetes

Renal / kidney

Patient-reported / QoL

Other (unclassified)

Glycemic / diabetes

1 endpoint

Secondary/protocol endpoint

Exenatide pharmacodynamics: Effect of exenatide on glucose homeostasis

Time frame:60 hours following first exenatide dose

descriptive

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Exenatide clinical efficacy: Effect of exenatide on intensity and duration of renal failure

Time frame:From PICU admission to PICU discharge, an average interval of 7.5 days

descriptive, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Exenatide clinical efficacy: Effect of exenatide on magnitude of sepsis-associated change in health-related quality of life

Time frame:2 measurements: baseline and PICU discharge, the latter occuring on average at 7.5 days

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Exenatide associated adverse event occurence

Time frame:From PICU admission to PICU discharge, an average interval of 7.5 days

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Exenatide pharmacokinetics: Area under the exenatide concentration curve for 4 subcutaneous exenatide injections administered every 12 hours.

Time frame:48 hours following the first exenatide dose

AUC₀–∞

concentration, descriptive