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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery

Treatments: Drug: PF-06473871

Study type: Interventional

Funder types: Industry

Identifiers

NCT02205476

B5301012

2014-002703-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 57 years old

Volunteers: No Healthy Volunteers

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of intolerable adverse reactions to PF-06473871, such as serious adverse events attributed to study drug or having been withdrawn due to AE in prerequisite study B5301001.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: PF-06473871

Drug: PF-06473871

Group 2

Experimental group

Description:

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

Treatment:

Drug: PF-06473871

Drug: PF-06473871