Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002703-17 | EudraCT Number |
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses). |
|
| Group 2 | Experimental | The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 2 = 3 doses). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06473871 | Drug | Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit | 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). | 52 weeks after initial scar revision surgery in study B5301001 |
| Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities | Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure. | Part B: Baseline up to Week 15 |
| Part B: Number of Participants With Clinical Laboratory Abnormalities | 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: Baseline up to Week 15 |
| Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit | 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). | 52 weeks after initial scar revision surgery in study B5301001 |
| Measure | Description | Time Frame |
|---|---|---|
| Volumetric & Colorimetric Scar Assessment (3D Imaging) at Part A Visit | 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. | 52 weeks after initial scar revision surgery in study B5301001 |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stephan Baker MD PA | Coral Gables | Florida | 33146 | United States | ||
| Bayside Ambulatory Center |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
Participants who completed part A of the study had the option to obtain scar revision surgery with PF-06473871 in part B of the study. No participant entered into part B due to premature termination of the study.
Participants who received the treatment in previous study B5301001 (NCT01730339), were enrolled in this study.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1: PF--06473871/Placebo (4* 5 mg/cm) | Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery. |
| FG001 | Group 2: PF--06473871/Placebo (3* 5 mg/cm) | Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1: PF--06473871/Placebo (4* 5 mg/cm) | Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Physician Scar Assessment Using Complete Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit | 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). | Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial. | Posted | Mean | Standard Deviation | units on scale | 52 weeks after initial scar revision surgery in study B5301001 |
|
Not provided
Adverse events were planned to be assessed in part B of the study. Part B of study was not initiated due to premature termination during part A of the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1: PF--06473871/Placebo (4* 5 mg/cm) | Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery. |
Not provided
Not provided
The study was prematurely terminated at the discretion of sponsor as study B5301001 did not meet its pre-defined efficacy endpoints for the dosing regimens evaluated.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| PF-06473871 | Drug | Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 3 administration of PF-06473871. |
|
| Part B: Baseline up to Week 15 |
| Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit | 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. | 52 weeks after initial scar revision surgery in study B5301001 |
| Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit | 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). | 52 weeks after initial scar revision surgery in study B5301001 |
| Miami |
| Florida |
| 33133 |
| United States |
| Kavali Plastic Surgery and Skin Renewal Center | Atlanta | Georgia | 30328 | United States |
| Primeter outpatient surgery center | Atlanta | Georgia | 30328 | United States |
| Body Aesthetic Research Center | St Louis | Missouri | 63141 | United States |
| BG001 | Group 2: PF--06473871/Placebo (3* 5 mg/cm) | Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Group 1: Placebo: 4* 5 mg/cm | Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery. |
| OG002 | Group 2: PF¬06473871: 3* 5 mg/cm | Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery. |
| OG003 | Group 2: Placebo: 3* 5 mg/cm | Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery. |
|
|
| Secondary | Patient Global Assessment Using Overall Opinion of Patient and Observer Scar Assessment Scale (POSAS) at Part A Visit | 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). | Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial. | Posted | Mean | Standard Deviation | units on scale | 52 weeks after initial scar revision surgery in study B5301001 |
|
|
|
| Secondary | Patient-Reported Scar Evaluation Questionnaire (PR-SEQ) Symptom and Appearance Domain Score at Part A Visit | 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. | Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial. | Posted | Mean | Standard Deviation | units on scale | 52 weeks after initial scar revision surgery in study B5301001 |
|
|
|
| Secondary | Physician and Participant Photoguide Scar Assessment Scale Score at Part A Visit | 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). | Enrolled analysis set included all participants who signed an informed consent and for whom data were collected for Part A of this trial. | Posted | Mean | Standard Deviation | units on scale | 52 weeks after initial scar revision surgery in study B5301001 |
|
|
|
| Primary | Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities | Vital signs included pulse rate and systolic blood pressure and diastolic blood pressure. | Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A. | Posted | Part B: Baseline up to Week 15 |
|
|
| Primary | Part B: Number of Participants With Clinical Laboratory Abnormalities | 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. | Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A. | Posted | Part B: Baseline up to Week 15 |
|
|
| Primary | Part B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs) | 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. | Data for this outcome measure was not analyzed because part B was not initiated due to early termination of the study during Part A. | Posted | Part B: Baseline up to Week 15 |
|
|
| Other Pre-specified | Volumetric & Colorimetric Scar Assessment (3D Imaging) at Part A Visit | 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. | The volumetric and colorimetric scar assessments were collected under this protocol but were not analyzed. | Posted | 52 weeks after initial scar revision surgery in study B5301001 |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group 2: PF--06473871/Placebo (3* 5 mg/cm) | Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery. | 0 | 0 | 0 | 0 |
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Symptoms |
|
| Participant assessment |
|