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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2015-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses).

Group Type EXPERIMENTAL

PF-06473871

Intervention Type DRUG

Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871.

Group 2

The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 2 = 3 doses).

Group Type EXPERIMENTAL

PF-06473871

Intervention Type DRUG

Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 3 administration of PF-06473871.

Interventions

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PF-06473871

Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

57 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No