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Pediatric Research

Pediatric Research

Pediatric research, in partnership with Mary Bridge Children’s Hospital & Health Network (Mary Bridge), is providing children in our community with access to the latest treatment options available for chronic, rare and life-threatening conditions. We strive to provide cutting-edge research studies that have strong applicability for Washington State children and their families.

Our research serves the smallest patients in the Neonatal Intensive Care Unit through the teen and young adult population treated at Mary Bridge and Tacoma General Hospital. Our goal is to improve the health of our children through evidence-based learning.

Pediatric Studies Accepting Patients

Dermatology

Atopic Dermatitis

Regeneron 1434

Study Number: R668-AD-1434 - An open-label extension study to assess the long-term safety and efficacy of Dupilumab in patients 6 months or greater to <18 years of age with atopic dermatitis.

Study Info

Principal Investigator: Aaron Pace, MD

Study Coordinator: Denise Quinn, [email protected], 253.301.6990


Liberty AD PRESCHOOL

Study Number: R668-AD-1539 - A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab In Patients Aged ≥6 Months to <6 Years With Severe Atopic Dermatitis

Study Info

Principal InvestigatorAaron Pace, MD

Study Coordinator: Danielle Wahinekapu, [email protected], 253-301-6992


PFIZER B7451014

Study Number: B7451014 - A PHASE 3 RANDOMIZED WITHDRAWAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 IN SUBJECTS AGED 12 YEARS AND OVER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH THE OPTION OF RESCUE TREATMENT IN FLARING SUBJECTS

Study Info

Principal InvestigatorAaron Pace, MD

Study Coordinator: Denise Quinn, [email protected], 253.301.6990


AD Extension Study

Study Number: Pfizer B7451015 - A Phase 3 Randomized, Double-Blind, Multi-Center, Long-Term Extension Study Investigating the Efficacy and Safety of PF04965842, with or without Topical Medications, Administered to Subjects Aged 12 Years and Older with Moderate to Severe Atopic Dermatitis

Study Info

Principal Investigator: Andrew Pace, MD

Study Coordinator: Denise Quinn, [email protected], 253.301.6990

Endocrinology

Growth Hormone Disorder

OPKO GHD

Study Number: CP-4-006—A Phase III open-label, randomized, multicenter, 12-months, efficacy and safety study of weekly MOD-4023 compared to daily Genotropin therapy in pre-pubertal children with growth hormone deficiency.

Study Info

Principal Investigator: Gadi Kletter, MD

Study Coordinator: Sophie Schmitter, [email protected], 253-403-2699


Pfizer

Study Number: C0311002 - A PHASE 3, RANDOMIZED, MULTICENTER, OPEN-LABEL, CROSSOVER STUDY ASSESSING SUBJECT PERCEPTION OF TREATMENT BURDEN WITH USE OF WEEKLY GROWTH HORMONE (SOMATROGON) VERSUS DAILY GROWTH HORMONE (GENOTROPIN) INJECTIONS IN CHILDREN WITH GROWTH HORMONE DEFICIENCY

Study Info

Principal Investigator(s):  Gad Kletter, MD

Study Coordinator: Sophie Schmitter, [email protected], 253.403.2699 


enliGHten

Study Number: ASCENDIS TRANSCON hGH CT-301EXT - A Multicenter, Phase 3, Long-term, Open-label Trial Investigating Safety and Efficacy of TransCon hGH Administered Once-Weekly in Children with Growth Hormone Deficiency (GHD) Who Have Completed a Prior TransCon hGH Clinical Trial

Study Info

Principal Investigator(s):  Gad Kletter, MD

Study Coordinator: Sophie Schmitter, [email protected], 253.403.2699

Precocious Puberty

Abbvie

Study Number: ABBVIE M16-904 - Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Leuprolide Acetate 45 mg 6-month formulation in Children with Central Precocious Puberty

Study Info

Principal Investigator(s):  Gad Kletter, MD

Study Coordinator: Sophie Schmitter, [email protected], 253.403.2699 

Type II Diabetes

AWARD-PEDS T2D

Study Number: H9X-MC-GBGC – A randomized, double-blind study with an open-label extension comparing the effect of once-weekly Dulaglutide with placebo in pediatric patients with Type II Diabetes Mellitus.

Study Info

Principal Investigator: Gadi Kletter, MD

Study Coordinator: Sophie Schmitter, [email protected], 253-403-2699


MK-0431A-289

Study Number: MK-0431A-289—A Phase III multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of MK-0431A XR (a fixed-dose combination tablet of Sitagliptin and extended-release Metformin) in pediatric patients with Type 2 diabetes mellitus with inadequate glycemic control on
Metformin therapy (alone or in combination with insulin).

Study Info

Principal Investigator(s):Gadi Kletter, MD

Study Coordinator: Sophie Schmitter, [email protected], 253-403-2699


Takeda

Study Number: Takeda SYR-322-309 - An multicenter, radomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Alogliptin compared with placebo in pediatric subjects with Type 2 Diabetes Mellitus.

Study Info

Principal Investigator(s):Gadi Kletter, MD

Study Coordinator: Sophie Schmitter, [email protected], 253-403-2699


CV181375

Study Number: D1680C00019 - A 24-week, multicenter, randomized, placebo-controlled, double-blind, parallel group, Phase III trials with 28-week safety extension period evaluating the safety and effect of Dapaglifozin 5 and 10 mg, and Saxagliptin 2.5 and 5 mg in pediatric patients with Type 2 diabetes mellitus who are between 10 and below 18 years of age.

Study Info

Principal Investigator(s):Gadi Kletter, MD

Study Coordinator: Sophie Schmitter, [email protected], 253-403-2699


MK-0431A-289

Study Number: A phase 3 multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of MK-0431A XR (a fixed-dose combination table of Sitagliptin and extended-release Metformin) in pediatric patients with Type 2 diabetes mellitus with inadequate glycemic control on Metformin therapy (alone or in combination with insulin).

Study Info

Principal Investigator(s):  Gad Kletter, MD

Study Coordinator: Sophie Schmitter, [email protected], 253.403.2699

Gastroenterology

Constipation & Irritable Bowel Syndrome

Allergan 63 Constipation & IBS

Study Number: LIN-MD-63- A multicenter, randomized, double-blind, placebo-controlled, parallel-group, safety and efficacy study of a range of Linaclotide doses administered orally to children, ages 7 to 17 years, with irritable bowel syndrome with constipation (IBS-C) (ie fulfill Rome III criteria for child/ adolescent IBS fulfill modified). Rome III criteria for child/ adolescent functional constipation.

Study Info

Principal Investigator(s):Melawati Yuwono, MD

Study Coordinator: Sophie Schmitter, [email protected], 253-403-2699


Allergan 3030

Study Number: 3030-202-002 - A Phase II randomized, double-blind, palcebo-controlled, parallel-group, dose-ranging study to evaluate the safety and efficacy of Eluxadoline in pediatric patients (age 12-17) with irritable bowel syndrome with diarrhea (IBS-D).

Study Info

Principal Investigator(s): Gad Kletter, MD

Study Coordinator: Sophie Schmitter, [email protected], 253-403-2699

Ulcerative Colitis

M11-290

Study Number: M11-290—A multi-center, randomized, double-blind, placebo-controlled study of the human anti-TNF monoclonal antibody adalimumab in pediatric subjects with moderate to severe ulcerative colitis.

Study Info

Principal Investigator(s):Melawati Yuwono, MD

Study Coordinator: Sophie Schmitter, [email protected], 253-403-2699

Crohn's Disease

PCD-MTX-001

Study Number: PCD-MTX-001 - A A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER PRAGMATIC CLINICAL TRIAL TO EVALUATE THE EFFECTIVENESS OF LOW DOSE ORAL METHOTREXATE IN PATIENTS WITH PEDIATRIC CROHN’S DISEASE INITIATING ANTI-TNF THERAPY

Study Info

Principal Investigator(s): Michael Pickens, DO

Study Coordinator: Sophie Schmitter, [email protected], 253.403.2699

Neonatal

Respiratory Distress Syndrome

Chiesi RDS

Study Number: CCD-5633AA1-02—A multi-center, double-blind, randomized, single dose, active-controlled study to investigate the efficacy and safety of Synthetic Surfactant (CHF 5633) in comparison to Porcine Surfactant (Poractant Alfa, Curosurf®) in the treatment of preterm neonates with respiratory distress syndrome.

Study Info

Principal Investigator(s):Michael Kuluz, MD

Study Coordinator: Janey Barnhart, [email protected], 253-403-7258

Neurology

Childhood Absence Seizures

INSYS 103

Study Number: A phase 2, open-label, dose-finding study to assess the efficacy, safety, tolerability and pharmaceutical grade synthetic cannabidiol oral solution in pediatric patients with treatment-resistant childhood absence seizures.

Study Info

Principal Investigator(s): Steven Phillips, MD

Study Coordinator: Cassidy Canorro, [email protected], 253-403-9348

Infantile Spasms

INSYS 082

Study Number: INS011-16-082—A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of Cannabidiol Oral Solution as Adjunctive Therapy with Vigabatrin as Initial Therapy in Patients with Infantile Spasms

Study Info

Principal Investigator(s): Steven Phillips, MD

Study Coordinator: Cassidy Canorro, [email protected], 253-403-9348

Lennox-Gastaut Syndrome

EISAI338

Study Number: E2007-G000-338—A multicenter, double-blind, randomized, placebo-controlled trial with an open-label extension phase of perampanel as adjunctive treatment in subjects at least 2 years of age with inadequately controlled seizures associated with Lennox-Gastaut Syndrome.

Study Info

Principal Investigator(s): Steven Phillips, MD

Study Coordinator: Cassidy Canorro, [email protected], 253-403-9348


YKP509C001

Study Number: YKP509C001—Phase I, Open-Label, Pharmacokinetic, Dose-Escalation Study of Carisbamate in Adult and Pediatric Subjects with Lennox-Gastaut Syndrome

Study Info

Principal Investigator(s): Steven Phillips, MD

Study Coordinator: Cassidy Canorro, [email protected], 253-403-9348

Dravet Syndrome

Zogenix 1503

Study Number: ZX008-1503—An open-label extension trial to assess the long-term safety of ZX008 (Fenfluramine Hydrochloride) oral solution as an adjunctive therapy in children and young adults with Dravet Syndrome.

Study Info

Principal Investigator(s): Steven Phillips, MD

Study Coordinator: Cassidy Canorro, [email protected], 253-403-9348


Zogenix 1602

Study Number: ZX008-1602 - An open-label trial to assess the safety of ZX008 (Fenfluramine Hydrochloride) oral solution in combination with cannabidiol, as an adjunctive therapy in children and young adults with Dravet Syndrome or Lennox-Gastaut Syndrome.

Study Info

Principal Investigator(s)Steven Phillips, MD

Study Coordinator: Cassidy Canorro, [email protected], 253-403-9348

Duchenne Muscular Dystrophy

MNK14112096

Study Number: MNK14112096 - A Multicenter, Randomized, Parallel Group, Double Blind, Multiple Dose, Placebo Controlled Study to Assess the Efficacy and Safety of MNK-1411 in Male Subjects 4 to 8 Years of Age With Duchenne Muscular Dystrophy

Study Info

Principal Investigator(s): Steven Phillips, MD

Study Coordinator: Cassidy Canorro, [email protected], 253-403-9348

Migraines

TEVA

Study Number: TV48125-CNS-10141 - A Single-Dose, Open-Label Study to Characterize the Pharmacokinetics, Safety and Tolerability of Subcutaneous Administration of Fremanezumab in Pediatric Migraine Patients (6 to 11 Years of Age Inclusive)

Study Info

Principal Investigator(s): Steven Phillips, MD

Study Coordinator: Cassidy Canorro, [email protected], 253-403-9348

Oncology

Pediatric

Click here to view open pediatric oncology studies available through our NW NCORP

Adolescent & Young Adult (AYA)

Click here to view open AYA oncology studies available through our NW NCORP

Pulmonology

Idiopathic Bilateral Cataracts

Study Number: 018CTXX15001—An observational, multicenter study of the prevalence of Cerebrotendinous Xanthomatosis (CTX) in patient populations diagnosed with early onset Idiopathic Bilateral Cataracts.

Study Info

Principal Investigator(s): Michael Raff, MD

Study Coordinator: Dalia Sherif, [email protected], 253-403-2698

RSV

MK-1654-002

Study Number: MK-1654-002—A Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1654 in Pre-Term and Full-Term Infants

Study Info

Principal Investigator(s): Timothy Murphy, MD 

Study Coordinator: Karyna Boykin, [email protected], 253-403-9349

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