Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)

NCT04278404 | Recruiting DMC

• 1 other identifier: Pro00103838
• Study Type: observational
• Target: 5,000
• Locations: 2 countries
• Sites: 51

Brief Summary

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

Conditions

Coronavirus Infection (COVID-19); Pulmonary Arterial Hypertension; Urinary Tract Infections in Children; Hypertension; Pain; Hyperphosphatemia; Primary Hyperaldosteronism; Edema; Hypokalemia; Heart Failure; Hemophilia; Menorrhagia; Insomnia; Pneumonia; Skin Infection; Arrythmia; Asthma in Children; Bronchopulmonary Dysplasia; Adrenal Insufficiency; Fibrinolysis; Hemorrhage; Attention Deficit Hyperactivity Disorder; Multisystem Inflammatory Syndrome in Children (MIS-C); Kawasaki Disease; Coagulation Disorder; Down Syndrome

Outcome Measures

Primary Outcomes (8)

• Clearance (CL) or apparent oral clearance (CL/F) as measured by PK sampling

  Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

• Volume of distribution (V) or apparent oral volume of distribution (V/F) as measured by PK sampling

  Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

• Elimination rate constant (ke) as measured by PK sampling

  Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

• Half-life (t1/2) as measured by PK sampling

  Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

• Absorption rate constant (ka) as measured by PK sampling

  Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

• AUC (area under the curve) as measured by PK sampling

  Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

• Maximum concentration (Cmax) as measured by PK sampling

  Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

• Time to achieve maximum concentration (Tmax) as measured by PK sampling

  Data will be collected up to 90 days from the time of consent. For participants with Down Syndrome enrolling at sites designated as Down Syndrome sites, participants will be in the study for up to 210 days.

Study Arms (1)

Children and young adults who are prescribed drugs of interest

Children and young adults who are prescribed drugs of interest as part of their routine medical care OR are SARS-CoV-2 positive.

Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:

Interventions

The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care: DRUG

The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.

Also known as: Aminocaproic acid, Amiodarone, Bosentan, Budesonide, Cefdinir, Cefepime, Ceftazidime, Clindamycin, Clobazam, Dexamethasone, Dexmedetomidine, Dextroamphetamine/Amphetamine, Fosfomycin, Furosemide, Gabapentin, Guanfacine, Hydrocortisone, Labetalol, Meropenem, Metformin, Milrinone, Nalbuphine, Nicardipine, Nifedipine, Oseltamivir, Oxycodone, Risperidone, Sertraline, Sevelamer Carbonate / Sevelamer Hydrochloride, Spironolactone, Terbutaline, Tranexamic acid, Voriconazole, Zolpidem, Azithromycin, Lopinavir/Ritonavir, Ribavirin, Tocilizumab, Anakinra, Aspirin, Canakinumab, Colchicine, Interferon, Remdesivir, Ruxolitinib, Sarilumab, Abatacept, Infliximab

Children and young adults who are prescribed drugs of interest

Eligibility Criteria

• Age: 0 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children under 21 years of age.

You may qualify if:

• Participant is \< 21 years of age
• Parent/ Legal Guardian/ Adult Participant can understand the consent process and is willing to provide informed consent/HIPAA:
• (a) Participant is receiving one or more of the study drugs of interest at the time of enrollment or (b) Participant is NOT receiving one or more of the study drugs of interest but is SARS-COV-2 positive within 60 days prior to enrollment

You may not qualify if:

• Participant has a known pregnancy
• Participants receiving one or more of the study drugs of interest at the time of enrollment, DOI administration or PK sampling: (Refer to DOI specific appendices for details on enrollment cohort specifications and additional eligibility criteria)
• Has had intermittent dialysis within previous 24 hours
• Has had a kidney transplant within previous 30 days
• Has had a liver transplant within previous 1 year
• Has had a stem cell transplant within previous 1 year
• Has had therapeutic hypothermia within previous 24 hours
• Has had plasmapheresis within the previous 24 hours
• Has a Ventricular Assist Device
• Has any condition which would make the participant, in the opinion of the investigator, unsuitable for the study

Sponsors & Collaborators

• Duke University: lead
• The Emmes Company, LLC: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (51)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

ACTIVE NOT RECRUITING

Arkansas Children's Hospital Research Institute

Little Rock, Arkansas, 72202, United States

RECRUITING

University of California, Los Angeles Medical Center

Los Angeles, California, 90095, United States

RECRUITING

Lucile Packard Children's Hospital

Palo Alto, California, 94304, United States

RECRUITING

Colorado University Denver

Aurora, Colorado, 80045, United States

RECRUITING

The Children's Hospital Colorado

Aurora, Colorado, 80045, United States

RECRUITING

Alfred I. DuPont Hospital for Children

Wilmington, Delaware, 19803, United States

COMPLETED

University of Florida Jacksonville Shands Medical Center

Jacksonville, Florida, 32209, United States

RECRUITING

Kapiolani Womens and Childrens Medical Center

Honolulu, Hawaii, 96826, United States

RECRUITING

Ann and Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Ann and Robert H. Lurie Childrens Hospital of Chicago

Chicago, Illinois, 60614, United States

RECRUITING

Riley Hospital for Children at Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

University of Iowa Stead Family Children's Hospital

Iowa City, Iowa, 52242, United States

RECRUITING

University of Kansas Medical Center-JG Kidney Institute

Kansas City, Kansas, 66160, United States

COMPLETED

University of Louisville Norton Childrens Hospital

Louisville, Kentucky, 40202, United States

RECRUITING

Tulane University Health Science Center

New Orleans, Louisiana, 70112, United States

COMPLETED

Ochsner Baptist Clinical Trials Unit

New Orleans, Louisiana, 70115, United States

RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

COMPLETED

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

ENROLLING BY INVITATION

Massachusetts General Hospital

Lexington, Massachusetts, 02421, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55455, United States

COMPLETED

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

RECRUITING

Mississippi Center for Advanced Medicine

Madison, Mississippi, 39110, United States

COMPLETED

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

COMPLETED

University of Nebraska Medical Center

Omaha, Nebraska, 68114, United States

RECRUITING

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

COMPLETED

University of New Mexico Health Science Center

Albuquerque, New Mexico, 87131, United States

COMPLETED

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Duke University Health System

Durham, North Carolina, 27710, United States

RECRUITING

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

Board of Regents of the University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Pennsylvania State University--Hershey Children's Hospital

Hershey, Pennsylvania, 17033, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

COMPLETED

Medical University of South Carolina Children's Hospital

Charleston, South Carolina, 29425, United States

RECRUITING

University of South Carolina

Columbia, South Carolina, 29208, United States

COMPLETED

Avera McKennan Hospital & University Medical Center

Sioux Falls, South Dakota, 57108, United States

COMPLETED

Monroe Carell Jr. Children's Hospital at Vanderbilt

Nashville, Tennessee, 37232, United States

RECRUITING

Dell Children's Medical Center of Central Texas

Austin, Texas, 78723, United States

RECRUITING

University of Texas-Southwestern Medical Center Dallas

Dallas, Texas, 75390, United States

ACTIVE NOT RECRUITING

University of Texas--Memorial Hermann Texas Medical Center

Houston, Texas, 77030, United States

RECRUITING

The Womens Hospital of Texas

Houston, Texas, 77054, United States

RECRUITING

University of Utah

Salt Lake City, Utah, 84113, United States

RECRUITING

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

West Virginia University Hospital

Morgantown, West Virginia, 26506, United States

ACTIVE NOT RECRUITING

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

University Wisconsin Madison

Madison, Wisconsin, 53705, United States

ENROLLING BY INVITATION

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

The Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

CHU Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

RECRUITING

Related Publications (11)

• Tremoulet A, Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Salgado A, Ian-U Chong S, Melloni C, Gao J, Benjamin DK Jr, Capparelli EV, Cohen-Wolkowiez M; Administrative Core Committee of the Best Pharmaceuticals for Children Act-Pediatric Trials Network. Characterization of the population pharmacokinetics of ampicillin in neonates using an opportunistic study design. Antimicrob Agents Chemother. 2014 Jun;58(6):3013-20. doi: 10.1128/AAC.02374-13. Epub 2014 Mar 10.

  PMID: 24614374 BACKGROUND

• Hornik CP, Benjamin DK Jr, Smith PB, Pencina MJ, Tremoulet AH, Capparelli EV, Ericson JE, Clark RH, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act-Pediatric Trials Network. Electronic Health Records and Pharmacokinetic Modeling to Assess the Relationship between Ampicillin Exposure and Seizure Risk in Neonates. J Pediatr. 2016 Nov;178:125-129.e1. doi: 10.1016/j.jpeds.2016.07.011. Epub 2016 Aug 10.

  PMID: 27522443 BACKGROUND

• Le J, Poindexter B, Sullivan JE, Laughon M, Delmore P, Blackford M, Yogev R, James LP, Melloni C, Harper B, Mitchell J, Benjamin DK Jr, Boakye-Agyeman F, Cohen-Wolkowiez M. Comparative Analysis of Ampicillin Plasma and Dried Blood Spot Pharmacokinetics in Neonates. Ther Drug Monit. 2018 Feb;40(1):103-108. doi: 10.1097/FTD.0000000000000466.

  PMID: 29271816 BACKGROUND

• Gonzalez D, Melloni C, Yogev R, Poindexter BB, Mendley SR, Delmore P, Sullivan JE, Autmizguine J, Lewandowski A, Harper B, Watt KM, Lewis KC, Capparelli EV, Benjamin DK Jr, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act - Pediatric Trials Network Administrative Core Committee. Use of opportunistic clinical data and a population pharmacokinetic model to support dosing of clindamycin for premature infants to adolescents. Clin Pharmacol Ther. 2014 Oct;96(4):429-37. doi: 10.1038/clpt.2014.134. Epub 2014 Jun 20.

  PMID: 24949994 BACKGROUND

• Gonzalez D, Delmore P, Bloom BT, Cotten CM, Poindexter BB, McGowan E, Shattuck K, Bradford KK, Smith PB, Cohen-Wolkowiez M, Morris M, Yin W, Benjamin DK Jr, Laughon MM. Clindamycin Pharmacokinetics and Safety in Preterm and Term Infants. Antimicrob Agents Chemother. 2016 Apr 22;60(5):2888-94. doi: 10.1128/AAC.03086-15. Print 2016 May.

  PMID: 26926644 BACKGROUND

• Gonzalez D, Melloni C, Poindexter BB, Yogev R, Atz AM, Sullivan JE, Mendley SR, Delmore P, Delinsky A, Zimmerman K, Lewandowski A, Harper B, Lewis KC, Benjamin DK Jr, Cohen-Wolkowiez M; Best Pharmaceuticals for Children Act--Pediatric Trials Network Administrative Core Committee. Simultaneous determination of trimethoprim and sulfamethoxazole in dried plasma and urine spots. Bioanalysis. 2015;7(9):1137-49. doi: 10.4155/bio.15.38.

  PMID: 26039810 BACKGROUND

• Autmizguine J, Melloni C, Hornik CP, Dallefeld S, Harper B, Yogev R, Sullivan JE, Atz AM, Al-Uzri A, Mendley S, Poindexter B, Mitchell J, Lewandowski A, Delmore P, Cohen-Wolkowiez M, Gonzalez D; the Pediatric Trials Network Steering Committee. Population Pharmacokinetics of Trimethoprim-Sulfamethoxazole in Infants and Children. Antimicrob Agents Chemother. 2017 Dec 21;62(1):e01813-17. doi: 10.1128/AAC.01813-17. Print 2018 Jan.

  PMID: 29084742 BACKGROUND

• Dallefeld SH, Atz AM, Yogev R, Sullivan JE, Al-Uzri A, Mendley SR, Laughon M, Hornik CP, Melloni C, Harper B, Lewandowski A, Mitchell J, Wu H, Green TP, Cohen-Wolkowiez M. A pharmacokinetic model for amiodarone in infants developed from an opportunistic sampling trial and published literature data. J Pharmacokinet Pharmacodyn. 2018 Jun;45(3):419-430. doi: 10.1007/s10928-018-9576-y. Epub 2018 Feb 12.

  PMID: 29435949 BACKGROUND

• Hornik CP, Gonzalez D, van den Anker J, Atz AM, Yogev R, Poindexter BB, Ng KC, Delmore P, Harper BL, Melloni C, Lewandowski A, Gelber C, Cohen-Wolkowiez M, Lee JH; Pediatric Trial Network Steering Committee. Population Pharmacokinetics of Intramuscular and Intravenous Ketamine in Children. J Clin Pharmacol. 2018 Aug;58(8):1092-1104. doi: 10.1002/jcph.1116. Epub 2018 Apr 20.

  PMID: 29677389 BACKGROUND

• Drolet BA, Boakye-Agyeman F, Harper B, Holland K, Lewandowski A, Stefanko N, Melloni C; Pediatric Trials Network Steering Committee (See Acknowledgments for a listing of committee members.). Systemic timolol exposure following topical application to infantile hemangiomas. J Am Acad Dermatol. 2020 Mar;82(3):733-736. doi: 10.1016/j.jaad.2019.02.029. Epub 2019 Feb 18. No abstract available.

  PMID: 30790601 BACKGROUND

• Hornik CP, Yogev R, Mourani PM, Watt KM, Sullivan JE, Atz AM, Speicher D, Al-Uzri A, Adu-Darko M, Payne EH, Gelber CE, Lin S, Harper B, Melloni C, Cohen-Wolkowiez M, Gonzalez D; Best Pharmaceuticals for Children Act-Pediatric Trials Network Steering Committee. Population Pharmacokinetics of Milrinone in Infants, Children, and Adolescents. J Clin Pharmacol. 2019 Dec;59(12):1606-1619. doi: 10.1002/jcph.1499. Epub 2019 Jul 17.

  PMID: 31317556 BACKGROUND

Related Links

• Food and Drug Administration. General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products
• Extracorporeal Life Support Organization (ELSO). ECLS Registry Report: International Summary Ann Arbor, MI: Extracorporeal Life Support Organization (ELSO); 2020
• Wildschut E, editor. Drug therapies in neonates and children during extracorporeal membrane oxygenation (ECMO); Keep your eyes open. Rotterdam, The Netherlands: Erasmus MC; 2010.

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, effluent samples, and plasma

MeSH Terms

Conditions

Coronavirus Infections; COVID-19; Pulmonary Arterial Hypertension; Hypertension; Pain; Hyperphosphatemia; Hyperaldosteronism; Edema; Hypokalemia; Heart Failure; Hemophilia A; Menorrhagia; Sleep Initiation and Maintenance Disorders; Pneumonia; Cellulitis; Arrhythmias, Cardiac; Bronchopulmonary Dysplasia; Adrenal Insufficiency; Hemorrhage; Attention Deficit Disorder with Hyperactivity; pediatric multisystem inflammatory disease, COVID-19 related; Mucocutaneous Lymph Node Syndrome; Hemostatic Disorders; Down Syndrome

Interventions

Aminocaproic Acid; Amiodarone; Bosentan; Budesonide; Cefdinir; Cefepime; Ceftazidime; Clindamycin; Clobazam; Dexamethasone; Dexmedetomidine; SLI381; Fosfomycin; Furosemide; Gabapentin; Guanfacine; Hydrocortisone; Labetalol; Meropenem; Metformin; Milrinone; Nalbuphine; Nicardipine; Nifedipine; Oseltamivir; Oxycodone; Risperidone; Sertraline; Sevelamer; Spironolactone; Terbutaline; Tranexamic Acid; Voriconazole; Zolpidem; Azithromycin; Lopinavir; Ribavirin; tocilizumab; Interleukin 1 Receptor Antagonist Protein; Aspirin; canakinumab; Colchicine; Interferons; remdesivir; ruxolitinib; sarilumab; Abatacept; Infliximab

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Pneumonia, Viral; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Hypertension, Pulmonary; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Water-Electrolyte Imbalance; Heart Diseases; Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathologic Processes; Menstruation Disturbances; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Skin Diseases, Infectious; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Ventilator-Induced Lung Injury; Lung Injury; Infant, Premature, Diseases; Infant, Newborn, Diseases; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Vasculitis; Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Intellectual Disability; Neurobehavioral Manifestations; Abnormalities, Multiple; Congenital Abnormalities; Chromosome Disorders

Intervention Hierarchy (Ancestors)

Aminocaproates; Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Cephalosporins; beta-Lactams; Lactams; Thiazines; Cephaloridine; Lincomycin; Lincosamides; Pyrrolidines; Glycosides; Carbohydrates; Benzodiazepines; Benzazepines; Pregnadienetriols; Pregnadienes; Steroids, Fluorinated; Imidazoles; Azoles; Organophosphonates; Organophosphorus Compounds; Sulfanilamides; Aniline Compounds; Amines; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Guanidines; Amidines; Phenylacetates; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Ethanolamines; Amino Alcohols; Alcohols; Salicylamides; Thienamycins; Carbapenems; Biguanides; Amrinone; Aminopyridines; Pyridines; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Dihydropyridines; Acetamides; Cyclohexenes; Codeine; Morphine Derivatives; Pyrimidinones; 1-Naphthylamine; Naphthalenes; Polyamines; Lactones; Triazoles; Erythromycin; Macrolides; Polyketides; Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Proteins; Biological Factors; Salicylates; Hydroxybenzoates; Phenols; Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Globulins; Antibodies, Monoclonal; Immunoproteins

Study Officials

• Chi Hornik

  Duke Clinical Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Hornik

CONTACT

(919) 260-7626; chi.hornik@duke.edu

Jerry Kirchner

CONTACT

(919) 812-1798; jerry.kirchner@duke.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 20, 2020
• Study Start: March 5, 2020
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2); US (49)