Last updated on June 2018

An Open-label Extension Study To Evaluate Safety Of PF-06252616 In Boys With Duchenne Muscular Dystrophy


Brief description of study

This study is an open-label extension to protocol B5161002 and will provide an assessment of the long term safety, efficacy, pharmacodynamics and pharmacokinetics of intravenous dosing of PF 06252616 in boys with Duchenne muscular dystrophy. Approximately 105 eligible subjects will be assigned to receive a monthly individualized maximum tolerated dose based on their tolerability profile/data from B5161002. This study will not contain a placebo comparator. Subjects will undergo safety evaluations (Laboratory, cardiac monitoring, physical exams, x-ray, MRI), functional capacity evaluations (4 stair climb, range of motion, strength testing, Northstar Ambulatory Assessment, upper limb functional testing, six minute walk test and pulmonary function tests) and pharmacokinetic testing.

Clinical Study Identifier: NCT02907619

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David Geffen School of Medicine at UCLA/UCLA Neorology
Los Angeles, CA United States
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Ronald Reagan UCLA Medical Center
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Ronald Reagan UCLA Pharmacy
Los Angeles, CA United States
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UCLA (David Geffen School of Medicine), Department of Orthopedic Surgery
Los Angeles, CA United States
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UCLA Clinical & Translational Research Center
Los Angeles, CA United States
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University of Iowa ICTS, Clinical Research Unit
Iowa City, IA United States
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Kennedy Krieger Institute Out-patient Center
Baltimore, MD United States
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Kennedy Krieger Institute
Baltimore, MD United States
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Johns Hopkins Hospital
Baltimore, MD United States
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Johns Hopkins Investigational Drug Service
Baltimore, MD United States
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Duke University Medical Center, Lenox Baker Children's Hospital
Durham, NC United States
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Duke University, Investigational Drug Pharmacy
Durham, NC United States
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Cincinnati Children's Hospital Medical Center
Cincinnati, OH United States
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Children's Hospital of Pittsburgh of UPMC
Pittsburgh, PA United States
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Alberta Children's Hospital
Calgary, AB Canada
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Children's Hospital- London Health Sciences Centre
London, ON Canada
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National Center of Neurology and Psychiatry
Kodaira, Japan
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Dubowitz Neuromuscular Centre, Institute of Child Health
London, United Kingdom
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Great Ormond Street Hospital
London, United Kingdom
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Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom
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Institute of Genetic Medicine,Muscle Team
Newcastle-upon-Tyne, United Kingdom
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Clinical Research Facility
Newcastle-upon-Tyne, United Kingdom
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University of Minnesota Masonic Children's Hospital
Minneapolis, MN United States
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St. Louis Childrens's Hospital
Saint Louis, MO United States
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University of Utah Center for Clinical and Translational Services (CCTS)
Salt Lake City, UT United States
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University of Utah Hospital
Salt Lake City, UT United States
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University of Utah Investigational Drug Services at Huntsman Cancer Institute
Salt Lake City, UT United States
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University of Utah School of Medicine
Salt Lake City, UT United States
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UBC Children's and Women's Health Centre of British Columbia
Vancouver, BC Canada
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Dipartimento Pediatrico Universitario-Ospedaliero Endocrinologia
Rome, Italy
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Farmacia Ospedaliera, IRCCS Ospedale Pediatrico Bambino Gesu
Rome, Italy
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IRCCS Ospedale Pediatrico Bambino Gesu - Centro Trials
Rome, Italy
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U.O. Malattie Neuromuscolari e Neurodegenerative, IRCCS Ospedale Pediatrico Bambino Gesu
Rome, Italy
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Hyogo college of medicine hospital
Nishinomiya-shi, Japan
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UOC Farmacia - Istituto Gianna Gaslini,
Genova, Italy
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UOC Medicina Fisica Riabilitativa - Istituto G. Gaslini
Genova, Italy
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UOC Neurologia Pediatrica e Malattie Muscolari Istituto Gianna Gaslini
Genova, Italy
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UOC Radiologia - Istituto Gianna Gaslini,
Genova, Italy
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UOS Dipartimentale Endocrinologia Clinica Sperimentale - Ist.
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St. Louis Children's Hospital
Saint Louis, MO United States
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Centre de Readaptation Marie Enfant (CRME)
Montreal, QC Canada
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CHU Sainte-Justine
Montreal, QC Canada
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University of California, Davis Medical Center
Sacramento, CA United States
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Massachusetts General Hospital
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