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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 1539

Study Number: R668-AD-1607 - An open-label, randomized, actual use study of Dupilumab auto-injector device in patients with atopic dermatitis.

Study Info

Principal Investigator: Aaron Pace, MD

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

Acne - Foamix

Study Number: FX2017-22- A randomized, double-blind, vehicle-controlled study to evaluate the efficacy and safety of topical administration of FMX101 for 12 weeks in the treatment of moderate to severe acne vulgaris.

Study Info

Principal Investigator: Aaron Pace, MD

Study Coordinator: Danielle Wahinekapu, [email protected], 253-301-6990

Endocrinology

Growth Hormone Disorder

Ascendis hGH

Study Number: hGH CT-301—A multicenter, Phase III, randomized, open-label, active controlled, parallel-group trial investigating the safety, tolerability, and efficacy of TransCon hGH administered once a week versus standard daily hGH replacement therapy over 52 weeks prepubertal children with growth hormone deficiency (GHD).

Study Info

Principal InvestigatorGadi Kletter, MD 

Study Coordinator: Katy Garrison, [email protected], 253-403-2699


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 InvestigatorGadi Kletter, MD 

Study Coordinator: Katy Garrison, [email protected], 253-403-2699

Type I Diabetes

Edition Junior

Study Number: Sanofi EFC13957 - A 6-month, multi-center, radomized, open-label, 2-arm, parallel group study comparing the efficacy and safety of a new formulation of Insulin Glargine and Lantus injected once daily in children and adolescents age 6-17 years with Type 1 Diabetes Mellitus with a 6-month safety extension period.  

Study Info

Principal Investigator: Gadi Kletter, MD

Study Coordinator: Katy Garrison, [email protected], 253-403-2699


T1GER

Study Number: CNTO148DML2001—A study of SIMPONI to arrest beta-cell loss in Type I diabetes (T1GER). 

Study Info

Principal InvestigatorGadi Kletter, MD 

Study Coordinator: Katy Garrison, [email protected], 253-403-2699

Type II Diabetes

Awards 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: Katy Garrison, [email protected], 253-403-2699


MK-0431-083

Study Number: MK-0431-083—A Phase III, multicenter, double-blind, randomized, placebo-controlled clinical trial to evaluate the safety and efficacy of Sitagliptin in pediatric patients with Type 2 diabetes mellitus with inadequate glycemic control.

Study Info

Principal Investigator(s): Gadi Kletter, MD

Study Coordinator: Katy Garrison, [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: Katy Garrison, [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: Katy Garrison, [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 efficact 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: Katy Garrison, [email protected], 253-403-2699


Janssen

Study Number: 28431754DIA3018 - A randomized, multicenter, double-blind, parallel-group, placebo-controlled study to investigate the efficacy and safety of Canagliflozin in children and adolescents (greater than or equal to 10 to < 18 years) with Type 2 diabetes mellitus.

Study Info

Principal Investigator(s): Gadi Kletter, MD

Study Coordinator: Katy Garrison, [email protected], 253-403-2699

Precocious Puberty

PCC Orphan Reach

Study Number: TOL2581—An open-label, single arm, multicenter study on the efficacy, safety and pharmacokinetics of Leuprolide Acetate 45 mg for injectable suspension controlled release in subjects with central precocious puberty (CPP).

Study Info

Principal Investigator(s): Gadi Kletter, MD

Study Coordinator: Katy Garrison, [email protected], 253-403-2699

 
Gastroenterology

Infant Formula Testing

15.04.US.HCN EAGLE

Study Number: EAGLE - A study to monitor the Use of an Amino Acid-Based Infant Formula 

Study Info

Principal Investigator(s): Melawati Yuwono, MD

Study Coordinator: Katy Garrison, [email protected], 253-403-2699

Constipation & Irritable Bowel Syndrome

Allergan IBS

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

Principal Investigator(s): Gad Kletter, MD

Study Coordinator: Katy Garrison, [email protected], 253-403-2699


Allergan Constipation

Study Number: LIN-MD-62- A multicenter, randomized, double-blind, placebo-controlled, parallel-group, safety and efficacy study of a range of Linaclotide doses administered orally to children, ages 6 to 17 years, who fulfill modified Rome III creiteria for child/ adolescent Functional Constipation (FC).

Principal Investigator(s): Melawati Yuwono, MD

Study Coordinator: Katy Garrison, [email protected], 253-403-2699


Allergan 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: Katy Garrison, [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: Katy Garrison, [email protected], 253-403-2699

Crohn's Disease

Cape Registry

Study Number: P11-292—A long-term non-interventional registry to assess safety and
effectiveness of Humira® (Adalimumab) in pediatric patients with moderately to
Severely Active Crohn’s Disease (CD) (CAPE).

Study Info

Principal Investigator(s): Melawati Yuwono, MD

Study Coordinator: Katy Garrison, [email protected], 253-403-2699

Internal Medicine

Northrup

Study Number: NG-BSTP-600-001—Evaluation of the CytoRADx SystemTM as a biodosimeter for Special Human Populations.

Principal Investigator(s): Daniel Ginsberg, MD

Study Coordinator: Juanita Baker, [email protected], 253-403-0366


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 CoordinatorJaney Barnhart, [email protected], 253-403-7258

Neurology

Tonic Clonic & Partial Onset Seizures

EISAI311

Study Number: E2007-G000-311—An open-label, multicenter, study with an extension phase to evaluate the safety, tolerability and exposure-efficacy relationship of perampanel oral suspension when administered as an adjunctive therapy in pediatric subjects (age 4 to greater than 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures.

Study Info

Principal Investigator(s)Steven Phillips, MD

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


Pfizer A0081105

Study Number: A0081105—A randomized, double-blind, placebo-controlled, parallel group, multicenter trial of Pregabalin as adjunctive therapy in pediatric and adult subjects with primary generalized tonic-clonic seizures.

Study Info

Principal Investigator(s)Steven Phillips, MD

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


Pfizer 207748

Study Number: A0081106—A 12-month, open-label study to evaluate the safety and tolerability of Pregabalin as adjunctive therpay in pediatric subjects one month to 16 years of age with partial onset seizures and primary generalized tonic-clonic seizures.

Study Info

Principal Investigator(s)Steven Phillips, MD

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


Pfizer 208469

Study Number: A0081042—A double-blind, placebo-controlled, parallel-group, multicenter study of the efficacy and safety of Pregabalin as adjunctive therapy in children one month through <4 years of age with partial onset seizures.

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

Dravet Syndrome

Zogenix 1501

Study Number: ZX008-1501—A multicenter, randomized, double-blind, parallel group, placebo-controlled trial of two fixed doses of ZX008 (Fenfluramine Hydrochloride) oral solution as an adjunctive therapy in children and young adults with Dravet Sydrome.

Study Info

Principal Investigator(s)Steven Phillips, MD

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


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

Partial Epilepsy

SEP093-364

Study Number: SEP093-364—An open-label Eslicarbazepine acetate long-term safety and tolerability study in children and adolescents (4 to 7 years).

Study Info

Principal Investigator(s)Steven Phillips, MD

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

Pulmonology

CTX Prevalence Study

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 CoordinatorDalia Sherif, [email protected], 253-403-2698

Non-interventional Cystic Fibrosis Study

Study Number: CTBM100C2407—A prospective observational study in cystic fibrosis patients with chronic respiratory Pseudomonas aeruginosa infection treated with TOBI Podhaler (tobramycin inhalation powder) or other FDA approved inhaled antipseudomonal antibacterial drugs.

Study Info

Principal Investigator(s): David Ricker, MD

Study CoordinatorJuanita Baker, [email protected], 253-403-0367

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Contact:
253-403-7249
Email: [email protected]