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

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NCT02205476

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Study Location
Stephan Baker MD PA
Coral Gables, Florida, 33146, United States
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Contact
1-800-718-1021
[email protected]
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1-800-718-1021

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adverse events attributed to study drug or having been withdrawn due to AE in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

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Hypertrophic Scars Resulting From Prior Breast Scar Revision SurgeryA Phase 2 Extension Study To Enroll Subjects Who Were Enrolled In B5301001 Study
NCT02205476
  1. Coral Gables, Florida
  2. Miami, Florida
  3. Atlanta, Georgia
  4. Atlanta, Georgia
  5. Saint Louis, Missouri
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • 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.
Study Arms  ICMJE
  • 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
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
 (submitted: January 26, 2015)		10
Original Estimated Enrollment  ICMJE
 (submitted: July 29, 2014)		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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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
Study Director:Pfizer CT.gov Call CenterPfizer
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