An Open-label Extension Study To Evaluate Safety Of PF-06252616 In Boys With Duchenne Muscular Dystrophy
Public ClinicalTrials.gov record NCT02907619. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG TERM SAFETY OF PF-06252616 IN BOYS WITH DUCHENNE MUSCULAR DYSTROPHY
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02907619
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 59 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Years to 18 Years
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 13, 2016 (Actual)
- Primary completion
- Nov 22, 2018 (Actual)
- Completion
- Nov 22, 2018 (Actual)
- Last update posted
- Nov 23, 2020
2016 – 2018
United States locations
- U.S. sites
- 26
- U.S. states
- 10
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| David Geffen School of Medicine at UCLA/UCLA Neurology | Los Angeles | California | 90095 | — |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | — |
| Ronald Reagan UCLA Pharmacy | Los Angeles | California | 90095 | — |
| UCLA (David Geffen School of Medicine), Department of Orthopedic Surgery | Los Angeles | California | 90095 | — |
| UCLA Clinical & Translational Research Center | Los Angeles | California | 90095 | — |
| University of California, Davis Medical Center | Sacramento | California | 95817 | — |
| University of Iowa ICTS, Clinical Research Unit | Iowa City | Iowa | 52242 | — |
| Kennedy Krieger Institute Out-patient Center | Baltimore | Maryland | 21205 | — |
| Kennedy Krieger Institute | Baltimore | Maryland | 21205 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Johns Hopkins Investigational Drug Service | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | 55454 | — |
| (For Drug deliveries) IDS Pharmacy | Minneapolis | Minnesota | 55455 | — |
| St. Louis Childrens's Hospital | St Louis | Missouri | 63110 | — |
| Duke University Medical Center, Lenox Baker Children's Hospital | Durham | North Carolina | 27705 | — |
| Duke University, Investigational Drug Pharmacy | Durham | North Carolina | 27710 | — |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| Center for Clinical and Translational Sciences | Salt Lake City | Utah | 84108 | — |
| Utah Center for Advanced Imaging and Research (UCAIR) | Salt Lake City | Utah | 84108 | — |
| Investigational Drug Services | Salt Lake City | Utah | 84112 | — |
| Utah Program for Inherited Neuromuscular Disorder | Salt Lake City | Utah | 84112 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| University of Utah School of Medicine | Salt Lake City | Utah | 84132 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02907619, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 23, 2020 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02907619 live on ClinicalTrials.gov.