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

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ClinicalTrials.gov Identifier: NCT02205476
Recruitment Status : Terminated (B5301001 study did not meet its predefined efficacy endpoints, the long term follow up study B5301012 was terminated in 1/6/2015. No safety concerns identified.)
First Posted : July 31, 2014
Results First Posted : January 28, 2016
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE July 29, 2014
First Posted Date  ICMJE July 31, 2014
Results First Submitted Date  ICMJE December 21, 2015
Results First Posted Date  ICMJE January 28, 2016
Last Update Posted Date January 28, 2016
Study Start Date  ICMJE December 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
  • Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit [ Time Frame: 52 weeks after initial scar revision surgery in study B5301001 ]
    Physician scar assessment was performed using 10-point POSAS scale. Physician rated each of the items (vascularity, pigmentation, thickness, relief, pliability, surface area and overall opinion) for a scar on a score of 1 (normal skin) to 10 (worst scar imaginable).
  • Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities [ Time Frame: Part B: Baseline up to Week 15 ]
    Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure.
  • Part B: Number of Participants With Clinical Laboratory Abnormalities [ Time Frame: Part B: Baseline up to Week 15 ]
    Clinical laboratory tests included clinical chemistry (sodium, potassium, chloride, bicarbonate, glucose, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma-glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase) and hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count) tests to be performed.
  • Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) [ Time Frame: Part B: Baseline up to Week 15 ]
    An Adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A.
Original Primary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
  • Physician scar assessment using the complete Patient and Observer Scar Assessment Scale (POSAS) at Part A visit. [ Time Frame: 1-8 weeks prior to screening ]
  • Physical examination including vital signs at Part B [ Time Frame: Screening, Week 0, Week 15 ]
  • Evaluation of clinical laboratory tests at Part B [ Time Frame: Screening, Week 0, Week 15 ]
  • Evaluation of adverse events at Part B [ Time Frame: Screening, week 0, Week 15 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2015)
  • Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit [ Time Frame: 52 weeks after initial scar revision surgery in study B5301001 ]
    Patient global assessment was performed using the overall opinion question of the POSAS scale. Participants were asked to rate the severity of their scar compared to normal skin. The overall opinion scale score ranged from 1 (normal skin) to 10 (very different from normal skin).
  • Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit [ Time Frame: 52 weeks after initial scar revision surgery in study B5301001 ]
    PR-SEQ questionnaire consisted of 30 different attributes of scars that included following four dimensions: appearance (5 attributes), symptoms (3 attributes), bothersomeness (8 attributes), and impacts on the quality of life (physical and emotional wellbeing [14 attributes]). Each question had 5 possible responses: not at all (0), slightly (1), moderately (2), very (3), and extremely (4). Subjects completed an abbreviated version which included only the Symptoms and Appearance dimensions to evaluate treatment outcomes. Each of the item scores were transformed into a 0 to 100 scale. Each dimension score was calculated from averaging the transformed scores (0 to 100 scaled) for specified items. Each domain score ranged from 0 to 100, with higher scores indicating higher severity.
  • Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit [ Time Frame: 52 weeks after initial scar revision surgery in study B5301001 ]
    Physician and participants rated severity of each scar using a photonumeric guide on a scale ranging from 1 to 5 (where 1 = minimal, 2 = mild, 3 = moderate, 4 = severe, 5 = very severe).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2014)
  • Patient Global Assess: The patient overall opinion of the POSAS at Part A visit [ Time Frame: 1-8 week prior to screening ]
  • Patient reported scar evaluation questionnaire (PR-SEQ) at Part A visit [ Time Frame: 1-8 week prior to screening ]
  • Physician & Subject Photoguide Scar Assessment at Part A visit [ Time Frame: 1-8 week prior to screening ]
  • Volumetric & colorimetric scar assessment at Part A visit [ Time Frame: 1-8 week prior to screening ]
Current Other Pre-specified Outcome Measures
 (submitted: December 21, 2015)
Volumetric & Colorimetric Scar Assessment (3D Imaging) at Part A Visit [ Time Frame: 52 weeks after initial scar revision surgery in study B5301001 ]
Three-dimension digital photography was planned to be taken of the participants scars for determination of scar volume, height, and color performed in a subset of selected investigational centers equipped with specialized 3D photographic equipment.
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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