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A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study

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NCT02205476

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Stephan Baker MD PA
Coral Gables, Florida, 33146 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-57 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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adverse events attributed to study drug or having been withdrawn due to AE in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.

NCT02205476
Pfizer
Terminated
A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study

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A Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study
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
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
  • Drug: PF-06473871
    Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871.
  • Drug: PF-06473871
    Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 3 administration of PF-06473871.
  • Experimental: Group 1
    The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses).
    Intervention: Drug: PF-06473871
  • Experimental: Group 2
    The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 2 = 3 doses).
    Intervention: Drug: PF-06473871
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
January 2015
January 2015   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sexes Eligible for Study: All
18 Years to 57 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02205476
B5301012
2014-002703-17 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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