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Pediatrics

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

Regeneron Atopic Dermatitis

Study Number: Regeneron R668-AD01539 - A phase 2/3 study investigating the pharamcokintics, safety, efficacy of Duplimab in patients aged > 6 months to <6 years wuth severe atopic dermatitis. 

Principal Investigator: Jeffrey Jacobs, MD

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

Endocrinology—Growth Hormone Deficiency (GHD)

13VR3

Study Number: 13VR3—An Open-Label, Long-Term Safety Study of A Longacting Human Growth Hormone Somavaratan (VRS-317) in Children with Growth Hormone Deficiency; The VISTA Study: Versartis Long-Term Safety Study of Somavaratan.

Study Info

Principal InvestigatorGadi Kletter, MD 

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

Ascendis hGH

Study NumberTransCon 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

NN8640-4172

Study Number: NN8640-4172—A randomized, multinational, active-controlled, open-labelled, dose finding, double-blinded, parallel group trial investigating efficacy and safety of once-weekly NNC0195-0092 treatment compared to daily growth hormone treatment (Norditropin® FlexPro®) in growth hormone treatment naïve pre-pubertal children with growth hormone deficiency

Study Info

Principal InvestigatorGadi Kletter, MD 

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


Endocrinology—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

 
Endocrinology—Type II Diabetes

AWARD-PEDS T2DM

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 T2DM

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 T2DM

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 Peds Endo

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

 
Endocrinology—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

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

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

M11-290 UC

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


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], 253-403-0367


Neonatal

Chiesi RDS Neonates

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

EISAI 311

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 < 12 years) with inadequately controlled partial-onset seizures or primary generalized tonic-clonic seizures. 

Study Info

Principal Investigator(s):  Stephen Phillips, MD

Study CoordinatorCassidy Canorro, [email protected], 253-403-9348

EISAI 338

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):  Stephen Phillips, MD

Study CoordinatorCassidy 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)Stephen Phillips, MD

Study CoordinatorCassidy 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):  Stephen Phillips, MD

Study CoordinatorCassidy 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 therapy 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):  Stephen Phillips, MD

Study CoordinatorCassidy Canorro, [email protected], 253-403-9348

SEP093-364

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

Study Info

Principal Investigator(s):  Stephen Phillips, MD

Study CoordinatorCassidy Canorro, [email protected], 253-403-9348

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 Syndrome.

Study Info

Principal Investigator(s):  Stephen Phillips, MD

Study CoordinatorCassidy 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):  Stephen Phillips, MD

Study CoordinatorCassidy 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