Donor Site ComplicationPhase 1/2NCT02737748
TWB-103 for Adult Patients With Split-Thickness Skin Graft Donor Site Wounds
A Phase 1/2 study testing TWB-103 Group in people with Donor Site Complication, run by Transwell Biotech Co., Ltd. at 3 sites in 2 countries.
Trial summary
Primary objective: 1. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) for Phase I in terms of Incidence of treatment-related AEs and SAEs (including infections and bleeding) 2. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Donor Site Complication
- What is being tested?
- TWB-103 Group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 6 Jul 2017to 7 May 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female/male patients, aged 20-65 years old
- Presenting a split-thickness skin graft donor site wound with a minimum size of 15 cm2 but no more than 100 cm2, with a minimum width of 3 cm and with an approximate thickness of 0.010~0.012 inches. The graft cannot be harvested from a site from which a skin graft was previously obtained.
- If the primary wound is a result of a thermal or chemical burn, the total body surface area of the said wound must be less than 15%.
- Females of childbearing potential must have a documented negative serum pregnancy test done at the screening visit, which is within 2 weeks prior the DSW creation and the treatment
- Both male and female patients must agree to use highly effective contraceptives from signing informed consent to 30 days after the last dose administration.
- Willing to comply with the study protocol and to sign the Informed Consent Form
Who cannot join
- 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:
- systemic or inhaled corticosteroids or immunosuppressant agents; or
- therapeutic doses of anticoagulants (e.g. Coumadin, Heparin, low molecular weight Heparin) for pre-existing medical conditions, for whom a dose interruption from Screening through the end of the study period is contraindicated.
- Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
Show all 18Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Japan2 sites
Nippon Medical School
Tokyo, 113-8603
Tokyo Medical University
Tokyo, 160-0023
About this study
Official title: A Phase I/II Study to Evaluate the Safety and Efficacy of TWB-103 in Adult Patients With Split-Thickness Skin Graft Donor Site Wounds (DSW)
Primary objective:
- To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) for Phase I in terms of Incidence of treatment-related AEs and SAEs (including infections and bleeding)
- To evaluate the efficacy for Phase I+II of TWB-103 in split-thickness skin graft donor site wounds (DSW) in terms of The healing time from DSW creation to 100% re-epithelialization
Secondary objective:
- To evaluate the efficacy of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary efficacy endpoints
- To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary safety endpoints
Read the detailed description
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.
- Conditions
- Donor Site Complication
- Being tested
- TWB-103 Group, Placebo Group
- Keywords
- Donor Site Wounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TWB-103 GroupDrug
Also called TWB-103+Tegaderm
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.
Placebo GroupDrug
Also called Placebo+Tegaderm
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: TWB-103 Group |
| 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). Receives: Drug: Placebo Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Days 42 or earlier
Secondary outcomes (26)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Days 42 or earlier
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start6 Jul 2017
- Primary completion7 May 2021
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Donor Site ComplicationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Transwell Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- A2 Healthcare Taiwan Corporation
- Responsible party
- Sponsor
- Investigators
- Niann-Tzyy Dai, MD, PhD., Principal investigator, Tri-Service General Hospital (TSGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02737748
- Sponsor's protocol ID
- 16-FDF-C001
- Status last verified
- Jun 2023
- First submitted
- 28 Mar 2016
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study to Evaluate the Safety and Efficacy of TWB-103 in Adult Patients With Split-Thickness Skin Graft Donor Site Wounds (DSW)
- ClinicalTrials.gov ID
- NCT02737748
- Acronym / sponsor ID
- 16-FDF-C001
- Conditions
- Donor Site Complication
- Keywords
- Donor Site Wounds
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Transwell Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- A2 Healthcare Taiwan Corporation
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 7 May 2021 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Posted 28 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary objective:
- To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) for Phase I in terms of Incidence of treatment-related AEs and SAEs (including infections and bleeding)
- To evaluate the efficacy for Phase I+II of TWB-103 in split-thickness skin graft donor site wounds (DSW) in terms of The healing time from DSW creation to 100% re-epithelialization
Secondary objective:
- To evaluate the efficacy of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary efficacy endpoints
- To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary safety endpoints
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TWB-103 Group | Experimental | Drug: TWB-103 GroupSubjects 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 | Drug: Placebo GroupSubjects will receive placebo 2 to 3 times till 100% re-epithelialization or up to 10 days (around once every 3 days). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female/male patients, aged 20-65 years old
- Presenting a split-thickness skin graft donor site wound with a minimum size of 15 cm2 but no more than 100 cm2, with a minimum width of 3 cm and with an approximate thickness of 0.010~0.012 inches. The graft cannot be harvested from a site from which a skin graft was previously obtained.
- If the primary wound is a result of a thermal or chemical burn, the total body surface area of the said wound must be less than 15%.
- Females of childbearing potential must have a documented negative serum pregnancy test done at the screening visit, which is within 2 weeks prior the DSW creation and the treatment
- Both male and female patients must agree to use highly effective contraceptives from signing informed consent to 30 days after the last dose administration.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TWB-103 GroupAlso: TWB-103+TegadermEach 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. | Drug | TWB-103 Group |
| Placebo GroupAlso: Placebo+TegadermEach 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. | Drug | Placebo Group |
Primary outcome
Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding)
Time frame: Day 0~Day 28
The number of participants with treatment-related AEs and SAEs (including infections and bleeding) will be observed for the 7 patients in Phase I
The Healing Time From DSW Creation to the First 100% Re-epithelialization With Confirmation for at Least 10 Days Apart Assessed by the Investigator
Time frame: Days 42 or earlier
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.
Number of Participants Reached Confirmed Healing Within 28 Days.
Time frame: Days 42 or earlier
The number of participants in Phase I and II reached confirmed healing by the investigator within 28 days.
26 secondary outcomes
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
Time frame: Days 42 or earlier
Number of Participants With Complete Wound Closure at Day 7, 10 and 14 After DSW Creation.
Time frame: 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
Time frame: Day 7, 10 and 14
The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score
Time frame: Days 3, 7, 10, 14, 28, 42, Day 90/180/270/360 from Day 28 or 42
Number of Participants With AEs and SAEs
Time frame: Screening~ Day 360 from Day 28 or 42
Changes in Post-treatment Physical Examination Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment Vital Signs-pulse Rate Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment Vital Signs-body Temperature Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment Vital Signs-systolic Blood Pressure Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment Vital Signs-diastolic Blood Pressure Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-hematology-white Blood Cells Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-hematology-neutrophils Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-hematology-Hemoglobin Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-hematology-Hematocrit Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-hematology-platelets Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-hematology-red Blood Cells Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-biochemistry-aspartate Aminotransferase Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-biochemistry-alanine Aminotransferase Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-biochemistry-serum Creatinine Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-biochemistry-blood Urea Nitrogen Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-biochemistry-Albumin Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-biochemistry-bilirubin Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-biochemistry-gamma-glutamyl Transferase Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Changes in Post-treatment General Laboratory Assessment-biochemistry-alkaline Phosphatase Compared to Baseline
Time frame: Days 3, 7, 10, 14, 28, 42
Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding)
Time frame: Screening~ Day 360 from Day 28 or 42
The Number of Censored Subjects Assessed by the Investigator and the First Additional Evaluator
Time frame: Days 42 or earlier
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Niann-Tzyy Dai, MD, PhD. principal investigator
Tri-Service General Hospital (TSGH)
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TWB-103 Group in people with Donor Site Complication, run by Transwell Biotech Co., Ltd. at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Japan, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jul 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding) (time frame: Day 0~Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.