A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study
NCT02205476
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Subjects previously randomized to Pfizer clinical study B5301001.
- Subjects must be able to tolerate up to a 3 hour scar revision surgery under sedation and local anesthesia.
- Pregnant female subject; breastfeeding female subjects; male subjects with partners
currently pregnant.
- Any previous history of intolerable adverse reactions to PF-06473871, such as serious
adverse events attributed to study drug or having been withdrawn due to AE in
prerequisite study B5301001.
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Descriptive Information | ||||
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Brief Title ICMJE | A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study | |||
Official Title ICMJE | A Long-term Efficacy Assessment Following Initial Scar Revision Surgery And Phase 2 Open-label Study To Evaluate Safety Of Re-treatment With Pf-06473871 | |||
Brief Summary | Study is a multicenter, two-part, open-label phase II study in adults, evaluating the safety and long-term efficacy of PF-06473871 one year after surgical revision and treatment with PF-06473871. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 10 | |||
Original Estimated Enrollment ICMJE | 50 | |||
Actual Study Completion Date ICMJE | January 2015 | |||
Actual Primary Completion Date | January 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 57 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT02205476 | |||
Other Study ID Numbers ICMJE | B5301012 2014-002703-17 ( EudraCT Number ) | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | December 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |