- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01053897
Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery
A Phase 2, Multicenter, Double-Blind, Placebo-Controlled Study of GBT009 for Treatment of Incisional Wounds Following Breast Reconstruction Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States
- Garnet BioTherapeutics Investigational Site
-
-
New York
-
Rochester, New York, United States
- Garnet BioTherapeutics Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Subjects must meet all of the following criteria to be considered eligible to participate in the study:
- be a female between 18 and 70 years of age, inclusive
- have a body mass index ≤ 32 kg/m2 and a body weight between 50 and 95 kg, inclusive
- be scheduled for a mastectomy with breast reconstruction surgery using an abdominal flap technique
- for women diagnosed with breast cancer, has standard of care treatment for breast cancer prior to surgery and will have standard of care treatment for breast cancer after surgery
- for subjects of childbearing potential, be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the FDA through completion of the study and have negative results on a serum pregnancy test done before administration of study medication (women who are postmenopausal [no menses for at least 2 years] are also eligible to participate)
- be able to understand the study procedures, agree to participate in the study program, and voluntarily provide written informed consent
Exclusion Criteria: Subjects who meet any of the following criteria will be excluded from participating in the study:
- have clinically significant laboratory abnormalities at screening
- have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant renal, hepatic, cardiovascular, metabolic, neurologic, psychiatric, coagulopathic disorder or other condition that would preclude participation in the study
- have received treatment for a severe, uncontrolled inflammatory disease or allergic condition within three months of screening
- have a life expectancy ≤ 2 years
- have a history of alcoholism or drug addiction or abuse within 5 years
- have evidence of a clinically significant abnormality upon evaluation of 12 lead ECG
- have evidence of any past or present clinically significant medical condition, including skin disease, that would impair wound healing
- have a history of keloid scar formation
- have existing scarring in the abdominal area of study that would interfere with the efficacy assessments
- have a history of (within the past 5 years) or an active malignancy, other than breast cancer
- have a breast cancer that has been staged at Stage IIIB, IIIC or IV
- have received a cytotoxic agent or have been treated with radiation within 90 days of screening and/or, in the opinion of the investigator, will likely require treatment in the 30 day period following the administration of study medication
- have received anticoagulation medication within 5 days of dosing with study medication
- have participated in any study involving an investigational product within 30 days before dosing with study medication
- have routinely used tobacco products within 6 months preceding the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo
|
Intradermal Injection following surgery
|
EXPERIMENTAL: GBT009
|
Intradermal Injection following surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Photography- Independent Scar Assessment Panel
Time Frame: 0.5, 1, 2, 3, 6, 9 and 12 Months
|
An independent panel was planned to review scar photography to determine more preferable outcomes.
Panel was not performed.
|
0.5, 1, 2, 3, 6, 9 and 12 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Scar Preference
Time Frame: 12 Month (End of Study)
|
Overall preference of the healing/appearance of each scar segment as completed by investigator and subject.
|
12 Month (End of Study)
|
Patient Observer Scar Assessment Scale (POSAS)
Time Frame: 12 Month (End of Study)
|
Rating by subject and investigator (observer) to assess various factors of scar segment appearance/characteristics on a numeric scale (0-10). Individual parameters rated by the subject or observer according to a 0-10 scale where 0 equals no symptoms or difference from normal (better) and 10 equals the worst possible symptoms or difference from normal (worse). Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months) |
12 Month (End of Study)
|
Manchester Scar Scale (MSS)
Time Frame: 12 Month (End of Study)
|
Rating by investigator to assess various factors of scar appearance/characteristics on numeric scales. MSS includes a visual analog scale (10 cm; 0 excellent appearance, 10 poor appearance) and four descriptive characteristics rated 1 to 4 according to the following descriptions. Color: Perfect (1), Slight mismatch (2), Obvious mismatch (3), Gross mismatch (4). Contour: Flush with surrounding skin (1), Slightly proud/indented (2), Hypertrophic (3), Keloid (4). Distortion: None (1), Mild (2), Moderate (3), Severe (4). Texture: Normal (1), Just palpable (2), Firm (3), Hard (4). Outcomes measured at 0.5, 1, 2, 3, 6, 9 and 12 Months. Reported Data is end of study (12 months) |
12 Month (End of Study)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Garnet Study Manager, Garnet BioTherapeutics, Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- GBT-09-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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