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| Name | Class |
|---|---|
| A2 Healthcare Taiwan Corporation | INDUSTRY |
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Primary objective:
Secondary objective:
The study was designed to evaluate the safety and efficacy of the TWB-103 in adult subjects with split-thickness skin graft donor site wounds (DSW). In Phase I proportion, eligible subjects were recruited sequentially with one week staggering of treatment. Eligible subjects were randomized into TWB-103 or Placebo groups in a 1:1 ratio. Phase I was planned to recruit 3 evaluable subjects each in TWB-103 and Placebo groups. Evaluable subjects in Phase I were (1) he/she who received at least one dose and had follow-up evaluation at least 14 days after the first dose or (2) he/she who received at least one dose and had early withdrawn due to safety reasons before Day 28. When all of those 6 evaluable subjects completed the planned treatment period (14 days or till first 100% re-epithelialization, which came first), the recruitment was temporarily stopped for 14 days for safety observation. The safety data before and on Day 28 Visit were reviewed by the sponsor and the principal investigator. If no safety issue was decided, the study would enter Phase II portion and eligible subjects would be randomized into a 1:1 ratio into one of the TWB-103 and Placebo groups. The dosing regimen designed in Phase II portion was the same as it was designed in Phase I portion.
Subjects were instructed to attend scheduled visits at Screening, Day 0 (treatment start the day), Day 3, Day 7, Day 10, and Day 14 (end of treatment). All subjects were scheduled to attend a follow-up visit on Day 28 to evaluate the status of the target wound and then enter a 360-day follow-up phase. During the 360-day follow-up, four follow-up visits were scheduled at 90±14 days, 180±14 days, 270±14 days, and 360±14 days following the subject's Day 28 visit (if no Day 42 visit) or Day 42 visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TWB-103 Group | Experimental | Subjects will receive TWB-103 2 to 3 times till 100% re-epithelialization or up to 10 days (around once every 3 days). |
|
| Placebo Group | Placebo Comparator | Subjects will receive placebo 2 to 3 times till 100% re-epithelialization or up to 10 days (around once every 3 days). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TWB-103 Group | Drug | Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding) | The number of participants with treatment-related AEs and SAEs (including infections and bleeding) will be observed for the 7 patients in Phase I | Day 0~Day 28 |
| The Healing Time From DSW Creation to the First 100% Re-epithelialization With Confirmation for at Least 10 Days Apart Assessed by the Investigator | The healing time from DSW creation to the first 100% re-epithelialization with confirmation for at least 10 days apart assessed by the investigator for all patients in Phase I and II. | Days 42 or earlier |
| Number of Participants Reached Confirmed Healing Within 28 Days. | The number of participants in Phase I and II reached confirmed healing by the investigator within 28 days. | Days 42 or earlier |
| Measure | Description | Time Frame |
|---|---|---|
| The Healing Time From DSW Creation to the First 100% Re-epithelialization With Confirmation for at Least 10 Days Apart, Assessed by the First Additional Evaluator | The healing time from DSW creation to the first 100% re-epithelialization with confirmation for at least 10 days apart assessed by the investigator for all patients in Phase I and II. The first additional evaluator judged the healing status by looking at the photos of DSW. |
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Inclusion Criteria:
Exclusion Criteria:
Female patients who are pregnant or lactating or planning a pregnancy and any male patient whose partner (wife) planning a pregnancy from signing informed consent to 30 days after the last dose administration.
Clinically significant disease or condition that may compromise graft take and/or donor site healing (e.g. the presence of a bleeding disorder, capillary fragility, venous or arterial disorder directly affecting the donor site to be treated, known or suspected systemic malignancies, human immunodeficiency virus infection, renal or liver disease, uncontrolled diabetes mellitus, thrombocytopenia, vasculitis, poor nutritional status).
Patients who are currently receiving or have received the following treatments within 4 weeks prior to study entry are excluded from the study:
Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
Hematologic disease, malignancy or hypo-immunity.
History of HIV or congenital immunodeficiency.
History of alcoholism or drug abuse.
Have used any tobacco product within 1 week prior to Day 0.
Patients previously treated with any cell-based product, including autologous tissue at the treatment site.
Received an investigational drug, device or biological/bioactive treatment within 30 days prior to Screening Visit.
Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the trial treatment.
History of sensitivity to bovine or porcine origin materials, or human serum albumin.
DSWs located in the face, over joints, lower legs or the buttocks
Any of the following hematologic abnormalities: (Hemoglobin < 10.0 g/dL, ANC < 1,500/μL, platelets < 75,000 /μL)
Any of the following serum chemistry abnormalities: (Total bilirubin > 1.5 × ULN, AST or ALT > 3 × ULN, gamma-GT > 2.5 x ULN, Alk-P > 2.5 x ULN, serum albumin < 2.7 g/dL, creatinine >1.5 x ULN, any other ≥ Grade 2 laboratory abnormality (based on CTCAE) at baseline (other than those listed above)
DSWs in area with active skin infection or with skin condition that is considered highly susceptible to infection judged by the investigator
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| Name | Affiliation | Role |
|---|---|---|
| Niann-Tzyy Dai, MD, PhD. | Tri-Service General Hospital (TSGH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nippon Medical School | Tokyo | 113-8603 | Japan | |||
| Tokyo Medical University |
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48 subjects were screened in this study; 8 subjects were screen failures, resulting in 40 randomized subjects.
This was a multicenter study enrolling subjects from one site in Taiwan and two sites in Japan, between July 06, 2017 and May 07, 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | TWB-103 Group | Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10. For all assessments, the baseline was defined as the most recently available data before the administration of 1st dose treatment. |
| FG001 | Placebo Group | Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10. For all assessments, the baseline was defined as the most recently available data before the administration of 1st dose treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
[Not Specified]
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| ID | Title | Description |
|---|---|---|
| BG000 | TWB-103 Group | Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10. The baseline was defined as the most recently available data before the administration of 1st dose treatment. |
| 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 | Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding) | The number of participants with treatment-related AEs and SAEs (including infections and bleeding) will be observed for the 7 patients in Phase I | Phase I was planned to recruit 3 evaluable subjects each in TWB-103 and Placebo groups. Evaluable subjects in Phase I were (1) he/she who received at least one dose and had follow-up evaluation at least 14 days after the first dose or (2) he/she who received at least one dose and had early withdrawn due to safety reasons before Day 28. | Posted | Count of Participants | Participants | Day 0~Day 28 |
|
Screening ~ Day 360 from Day 28 or 42
The primary safety endpoint of Phase I part was the incidence of treatment-related AEs and SAEs. Among 7 subjects (3 in TWB-103 group and 4 in Placebo group) included for the evaluation. For the whole study, 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included for safety analysis.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TWB-103 add-on Tegaderm | TWB-103 is the primary therapeutics with the use of Tegaderm as a wound-site protection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | Systematic Assessment |
Some cases that healing observed by 1st evaluator could not be confirmed due to the lack of following visits. These are considered as flaws of protocol design.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bin-Ru She | Transwell Biotech Co., Ltd. | +886-3-5670399 | 207 | binru.she@tw-bio.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 11, 2019 | May 5, 2023 | Prot_SAP_000.pdf |
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|
| Placebo Group | Drug | Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10. |
|
|
| Days 42 or earlier |
| Number of Participants With Complete Wound Closure at Day 7, 10 and 14 After DSW Creation. | Complete wound closure is defined as skin 100% re-epithelialization without drainage or dressing requirements. This endpoint will be in all patients in Phase I and II. | Day 7, 10 and 14 |
| The Healing Percentage of Wounds (Ratio of Healing Area and Original Area) at Days 7, 10 and 14 After DSW Creation | The healing percentage of wounds will be calculated based on the healing area measured on Day 7, 10 and 14, comparing to the original area measured on Day 0 for all patients in Phase I and II. | Day 7, 10 and 14 |
| The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score | All patients in Phase I and II will evaluate the pain based on Short-form McGill pain questionnaire at each visit. The visual analogue scale (VAS) for pain is a continuous scale comprised of a horizontal line, usually, 10 cm (= 100 mm) in length, scored from 0 (none) to 10 (extreme). On this scale, a higher score in VAS indicates the worse pain. | Days 3, 7, 10, 14, 28, 42, Day 90/180/270/360 from Day 28 or 42 |
| Number of Participants With AEs and SAEs | The number of participants with AEs and SAEs will be analyzed for all patients in Phase I and II. | Screening~ Day 360 from Day 28 or 42 |
| Changes in Post-treatment Physical Examination Compared to Baseline | Changes in post-treatment physical examination will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment Vital Signs-pulse Rate Compared to Baseline | Changes in post-treatment vital signs-pulse rate will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment Vital Signs-body Temperature Compared to Baseline | Changes in post-treatment vital signs-body temperature will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment Vital Signs-systolic Blood Pressure Compared to Baseline | Changes in post-treatment vital signs-systolic blood pressure will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment Vital Signs-diastolic Blood Pressure Compared to Baseline | Changes in post-treatment vital signs-diastolic blood pressure will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-hematology-white Blood Cells Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-white blood cells will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-hematology-neutrophils Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-neutrophils will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-hematology-Hemoglobin Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-hemoglobin will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-hematology-Hematocrit Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-hematocrit will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-hematology-platelets Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-platelets will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-hematology-red Blood Cells Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-red blood cells will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-biochemistry-aspartate Aminotransferase Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-aspartate aminotransferase will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-biochemistry-alanine Aminotransferase Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-alanine aminotransferase will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-biochemistry-serum Creatinine Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-serum creatinine will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-biochemistry-blood Urea Nitrogen Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-blood urea nitrogen will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-biochemistry-Albumin Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-albumin will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-biochemistry-bilirubin Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-bilirubin will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-biochemistry-gamma-glutamyl Transferase Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-gamma-glutamyl transferase will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Changes in Post-treatment General Laboratory Assessment-biochemistry-alkaline Phosphatase Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-alkaline phosphatase will be analyzed for all patients in Phase I and II. | Days 3, 7, 10, 14, 28, 42 |
| Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding) | The number of participants with treatment-related AEs and SAEs (including infections and bleeding) will be observed for all patients in Phase I and II | Screening~ Day 360 from Day 28 or 42 |
| The Number of Censored Subjects Assessed by the Investigator and the First Additional Evaluator | The number of censored subjects in Phase I and II assessed by the investigator and the first additional evaluator. The first additional evaluator judged the healing status by looking at the photos of DSW. If the 100% re-epithelialization was not observed by Day 28 visit, the healing time was censored on the day of the last visit up to Day 28 visit. If the 100% re-epithelialization was observed by Day 28 visit but no confirmation was made, the healing time was censored on day of the last visit up to Day 28 visit. | Days 42 or earlier |
| Tokyo |
| 160-0023 |
| Japan |
| Tri-Service General Hospital | Taipei | 114 | Taiwan |
| BG001 |
| Placebo Group |
Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10. The baseline was defined as the most recently available data before the administration of 1st dose treatment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Baseline Donor Site Wound (DSW) Size | Mean | Standard Deviation | cm^2 |
|
| OG001 | Placebo Group | Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10. |
|
|
| Primary | The Healing Time From DSW Creation to the First 100% Re-epithelialization With Confirmation for at Least 10 Days Apart Assessed by the Investigator | The healing time from DSW creation to the first 100% re-epithelialization with confirmation for at least 10 days apart assessed by the investigator for all patients in Phase I and II. | Case first 100% re-epithelialization at any visit till Visit 7 (Day 28 Visit) with confirmation for at least 10 days apart: Healing Time [days] = date of first 100% re-epithelialization - date of DSW creation (Visit 2). Case else: Censored Healing Time [days] = date of last assessment up to Visit 7 - date of DSW creation (Visit 2). | Posted | Median | 95% Confidence Interval | Healing Time [days] | Days 42 or earlier |
|
|
|
|
| Primary | Number of Participants Reached Confirmed Healing Within 28 Days. | The number of participants in Phase I and II reached confirmed healing by the investigator within 28 days. | Case first 100% re-epithelialization at any visit till Visit 7 (Day 28 Visit) with confirmation for at least 10 days apart: Healing Time [days] = date of first 100% re-epithelialization - date of DSW creation (Visit 2). Case else: Censored Healing Time [days] = date of last assessment up to Visit 7 - date of DSW creation (Visit 2). | Posted | Count of Participants | Participants | Days 42 or earlier |
|
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|
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| Secondary | The Healing Time From DSW Creation to the First 100% Re-epithelialization With Confirmation for at Least 10 Days Apart, Assessed by the First Additional Evaluator | The healing time from DSW creation to the first 100% re-epithelialization with confirmation for at least 10 days apart assessed by the investigator for all patients in Phase I and II. The first additional evaluator judged the healing status by looking at the photos of DSW. | The additional evaluator who was not aware of the treatment groups would assess the wound based on the photos. Case first 100% re-epithelialization at any visit till Visit 7 (Day 28 Visit) with confirmation for at least 10 days apart: Healing Time [days] = date of first 100% re-epithelialization - date of DSW creation (Visit 2). Case else: Censored Healing Time [days] = date of last assessment up to Visit 7 - date of DSW creation (Visit 2). | Posted | Mean | Standard Error | Healing Time [days] | Days 42 or earlier |
|
|
|
|
| Secondary | Number of Participants With Complete Wound Closure at Day 7, 10 and 14 After DSW Creation. | Complete wound closure is defined as skin 100% re-epithelialization without drainage or dressing requirements. This endpoint will be in all patients in Phase I and II. | Healing rates (complete wound closure) of subjects at Days 7, 10, and 14 after DSW creation were analyzed. Due to the study design, subjects would skip the following treatment visits when their wound was completely closed, resulting in the smaller subject numbers at Visit 5 (N=18) and Visit 6 (N=10). To rectify this issue, post-hoc LOCF analysis was performed. | Posted | Count of Participants | Participants | Day 7, 10 and 14 |
|
|
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| Secondary | The Healing Percentage of Wounds (Ratio of Healing Area and Original Area) at Days 7, 10 and 14 After DSW Creation | The healing percentage of wounds will be calculated based on the healing area measured on Day 7, 10 and 14, comparing to the original area measured on Day 0 for all patients in Phase I and II. | Healing percentage was measured by the study investigator. Due to the study design, subjects would skip the following treatment visits when their wound was completely closed, resulting in the smaller subject numbers at Visit 5 (N=18) and Visit 6 (N=10). To rectify this issue, post-hoc LOCF analysis was performed. | Posted | Least Squares Mean | Standard Error | Healing Percentage (%) | Day 7, 10 and 14 |
|
|
|
| Secondary | The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score | All patients in Phase I and II will evaluate the pain based on Short-form McGill pain questionnaire at each visit. The visual analogue scale (VAS) for pain is a continuous scale comprised of a horizontal line, usually, 10 cm (= 100 mm) in length, scored from 0 (none) to 10 (extreme). On this scale, a higher score in VAS indicates the worse pain. | The pain assessment was measured by employing short-form McGill pain questionnaire at all scheduled visits, except Visit 2 (Day 0). The visual analogue scale (VAS) for pain is a continuous scale comprised of a horizontal line, usually, 10 cm (= 100 mm) in length, scored from 0 (none) to 10 (extreme). On this scale, a higher score in VAS indicates the worse pain. | Posted | Mean | Standard Deviation | VAS (0~10 cm) | Days 3, 7, 10, 14, 28, 42, Day 90/180/270/360 from Day 28 or 42 |
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| Secondary | Number of Participants With AEs and SAEs | The number of participants with AEs and SAEs will be analyzed for all patients in Phase I and II. | 40 subjects (20 in TWB-103 group and 20 in Placebo group) were included in the population for safety analysis. Treatment-emergent adverse events (TEAE) were classified as treatment-related AE, Grade 3 or greater AE, AE that required to take special actions, SAE, or SUSAR during the study. | Posted | Count of Participants | Participants | Screening~ Day 360 from Day 28 or 42 |
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| Secondary | Changes in Post-treatment Physical Examination Compared to Baseline | Changes in post-treatment physical examination will be analyzed for all patients in Phase I and II. | The physical examination of each subject was examined at all scheduled visits. | Posted | Number | Participant with Physical Abnormality | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment Vital Signs-pulse Rate Compared to Baseline | Changes in post-treatment vital signs-pulse rate will be analyzed for all patients in Phase I and II. | The vital signs-pulse rate of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Pulse Rate [beats/min] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment Vital Signs-body Temperature Compared to Baseline | Changes in post-treatment vital signs-body temperature will be analyzed for all patients in Phase I and II. | The vital signs-body temperature of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Body Temperature [degree C] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment Vital Signs-systolic Blood Pressure Compared to Baseline | Changes in post-treatment vital signs-systolic blood pressure will be analyzed for all patients in Phase I and II. | The vital signs-systolic blood pressure of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Systolic Blood Pressure [mmHg] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment Vital Signs-diastolic Blood Pressure Compared to Baseline | Changes in post-treatment vital signs-diastolic blood pressure will be analyzed for all patients in Phase I and II. | The vital signs-diastolic blood pressure of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Diastolic Blood Pressure [mmHg] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-hematology-white Blood Cells Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-white blood cells will be analyzed for all patients in Phase I and II. | The general laboratory assessment-hematology-white blood cells of each subject were examined at all scheduled visits. | Posted | Mean | Standard Deviation | 10^9 cells /L | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-hematology-neutrophils Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-neutrophils will be analyzed for all patients in Phase I and II. | The general laboratory assessment-hematology-neutrophils of each subject were examined at all scheduled visits. | Posted | Mean | Standard Deviation | 10^9 cells /L | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-hematology-Hemoglobin Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-hemoglobin will be analyzed for all patients in Phase I and II. | The general laboratory assessment-hematology-hemoglobin of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Hemoglobin [g/dL] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-hematology-Hematocrit Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-hematocrit will be analyzed for all patients in Phase I and II. | The general laboratory assessment-hematology-hematocrit of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Hematocrit [%] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-hematology-platelets Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-platelets will be analyzed for all patients in Phase I and II. | The general laboratory assessment-hematology-platelets of each subject were examined at all scheduled visits. | Posted | Mean | Standard Deviation | 10^9 platelets/L | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-hematology-red Blood Cells Compared to Baseline | Changes in post-treatment general laboratory assessment-hematology-red blood cells will be analyzed for all patients in Phase I and II. | The general laboratory assessment-hematology-red blood cells of each subject were examined at all scheduled visits. | Posted | Mean | Standard Deviation | 10^12 cells/L | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-aspartate Aminotransferase Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-aspartate aminotransferase will be analyzed for all patients in Phase I and II. | The general laboratory assessment-biochemistry-aspartate aminotransferase of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Aspartate Aminotransferase [U/L] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-alanine Aminotransferase Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-alanine aminotransferase will be analyzed for all patients in Phase I and II. | The general laboratory assessment-biochemistry-alanine aminotransferase of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Alanine Aminotransferase [U/L] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-serum Creatinine Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-serum creatinine will be analyzed for all patients in Phase I and II. | The general laboratory assessment-biochemistry-serum creatinine of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Serum Creatinine [umol/L] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-blood Urea Nitrogen Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-blood urea nitrogen will be analyzed for all patients in Phase I and II. | The general laboratory assessment-biochemistry-blood urea nitrogen of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Blood Urea Nitrogen [mg/dL] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-Albumin Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-albumin will be analyzed for all patients in Phase I and II. | The general laboratory assessment-biochemistry-albumin of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Albumin [g/dL] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-bilirubin Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-bilirubin will be analyzed for all patients in Phase I and II. | The general laboratory assessment-biochemistry-bilirubin of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Bilirubin [umol/L] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-gamma-glutamyl Transferase Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-gamma-glutamyl transferase will be analyzed for all patients in Phase I and II. | The general laboratory assessment-biochemistry-gamma-glutamyl transferase of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Gamma-Glutamyl Transferase [U/L] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Changes in Post-treatment General Laboratory Assessment-biochemistry-alkaline Phosphatase Compared to Baseline | Changes in post-treatment general laboratory assessment-biochemistry-alkaline phosphatase will be analyzed for all patients in Phase I and II. | The general laboratory assessment-biochemistry-alkaline phosphatase of each subject was examined at all scheduled visits. | Posted | Mean | Standard Deviation | Alkaline Phosphatase [U/L] | Days 3, 7, 10, 14, 28, 42 |
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| Secondary | Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding) | The number of participants with treatment-related AEs and SAEs (including infections and bleeding) will be observed for all patients in Phase I and II | Posted | Count of Participants | Participants | Screening~ Day 360 from Day 28 or 42 |
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| Secondary | The Number of Censored Subjects Assessed by the Investigator and the First Additional Evaluator | The number of censored subjects in Phase I and II assessed by the investigator and the first additional evaluator. The first additional evaluator judged the healing status by looking at the photos of DSW. If the 100% re-epithelialization was not observed by Day 28 visit, the healing time was censored on the day of the last visit up to Day 28 visit. If the 100% re-epithelialization was observed by Day 28 visit but no confirmation was made, the healing time was censored on day of the last visit up to Day 28 visit. | The additional evaluator who was not aware of the treatment groups would assess the wound based on the photos. Case first 100% re-epithelialization at any visit till Visit 7 (Day 28 Visit) with confirmation for at least 10 days apart: Healing Time [days] = date of first 100% re-epithelialization - date of DSW creation (Visit 2). Case else: Censored Healing Time [days] = date of last assessment up to Visit 7 - date of DSW creation (Visit 2). | Posted | Count of Participants | Participants | Days 42 or earlier |
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| 0 |
| 20 |
| 0 |
| 20 |
| 7 |
| 20 |
| EG001 | Placebo+Tegaderm | Placebo to TWB-103 with the use of Tegaderm as a wound-site protection | 0 | 20 | 0 | 20 | 10 | 20 |
| Deafness neurosensory | Ear and labyrinth disorders | Systematic Assessment |
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| Application site dermatitis | General disorders | Systematic Assessment |
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| Application site discharge | General disorders | Systematic Assessment |
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| Application site erosion | General disorders | Systematic Assessment |
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| Application site pruritus | General disorders | Systematic Assessment |
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| Pyrexia | General disorders | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | Systematic Assessment |
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| Application site folliculitis | Infections and infestations | Systematic Assessment |
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| Cellulitis | Infections and infestations | Systematic Assessment |
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| Skin infection | Infections and infestations | Systematic Assessment |
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| Vaginal infection | Infections and infestations | Systematic Assessment |
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| Vulvitis | Infections and infestations | Systematic Assessment |
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| Wound infection | Infections and infestations | Systematic Assessment |
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| Type 2 diabetes mellitus | Metabolism and nutrition disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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Not provided
Not provided
| Adjusted Visit 6 (Day 14) with LOCF |
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| Adjusted Visit 6 (Day 14) with LOCF |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Adjusted Visit 8 (Day 42) |
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| Visit 9 (FU 3 Months) |
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| Visit 10 (FU 6 Months) |
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| Visit 11 (FU 9 Months) |
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| Visit 12 (FU 12 Months) |
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| Grade≥3 AE |
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| Grade ≥ 3 Treatment-Related AE |
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| AE Leading to Action Taken |
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| AE Leading to Drug withdrawn |
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| SAE |
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| Death SAE |
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| SUSAR |
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| Death SUSAR |
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| Adjusted Visit 4 (Day 7) (Multi-Selection by Body System) |
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| Adjusted Visit 5 (Day 10) (Multi-Selection by Body System) |
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| Adjusted Visit 6 (Day 14) (Multi-Selection by Body System) |
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| Adjusted Visit 7 (Day 28) (Multi-Selection by Body System) |
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| Visit 8 (Day 42) (Multi-Selection by Body System) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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| Adjusted Visit 3 (Day 3) |
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| Adjusted Visit 4 (Day 7) |
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| Adjusted Visit 5 (Day 10) |
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| Adjusted Visit 6 (Day 14) |
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| Adjusted Visit 7 (Day 28) |
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| Visit 8 (Day 42) |
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