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TWB-103 for Adult Patients With Split-Thickness Skin Graft Donor Site Wounds

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ClinicalTrials.gov Identifier: NCT02737748
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
A2 Healthcare Taiwan Corporation
Information provided by (Responsible Party):
Transwell Biotech Co., Ltd.

Tracking Information
First Submitted Date  ICMJE March 28, 2016
First Posted Date  ICMJE April 14, 2016
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE June 2, 2017
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
  • Incidence of treatment-related AEs and SAEs (including infections and bleeding) [ Time Frame: Day 0~Day 28 ]
    The incidence of treatment-related AEs and SAEs (including infections and bleeding) will be observed for the 6 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2016)
  • Incidence of treatment-related AEs and SAEs (including infections and bleeding) [ Time Frame: Day 14 ]
  • The healing time from DSW creation to 100% re-epithelialization assessed by the investigator [ Time Frame: Days 14 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
  • 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 ]
    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 for all patients in Phase I and II
  • The healing rates (complete wound closure) of patients at Day 7, 10 and 14 after DSW creation [ Time Frame: Day 7, 10 and 14 ]
    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.
  • 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 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.
  • 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 ]
    All patients in Phase I and II will evaluate the pain based on Short-form McGill pain questionnaire at each visit.
  • Incidence of AEs and SAEs [ Time Frame: Screening~ Day 360 from Day 28 or 42 ]
    All incidence of AEs and SAEs will be analyzed for all patients in Phase I and II.
  • Changes in post-treatment physical examination, vital signs, and general laboratory assessment compared to baseline [ Time Frame: Days 3, 7, 10, 14, 28, 42 ]
    Will be analyzed for all patients in Phase I and II.
  • Incidence of treatment-related AEs and SAEs (including infections and bleeding) [ Time Frame: Screening~ Day 360 from Day 28 or 42 ]
    The incidence of treatment-related AEs and SAEs (including infections and bleeding) will be observed for all patients in Phase I and II
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2016)
  • The healing time from DSW creation to 100% re-epithelialization assessed by additional evaluator [ Time Frame: Days 3, 7, 10, 14 ]
  • The healing rates (complete wound closure) of patients 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 ]
  • Change from baseline in Short-form McGill Pain Questionnaire Score [ Time Frame: Days 3, 7, 10, 14 ]
  • Incidence of AEs and SAEs [ Time Frame: Days 3, 7, 10, 14 ]
  • Changes in post-treatment physical examination, vital signs, and general laboratory assessment compared to baseline [ Time Frame: Days 3, 7, 10, 14 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TWB-103 for Adult Patients With Split-Thickness Skin Graft Donor Site Wounds
Official Title  ICMJE 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)
Brief 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. 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:

  1. To evaluate the efficacy of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary efficacy endpoints
  2. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary safety endpoints
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Donor Site Complication
Intervention  ICMJE
  • Drug: TWB-103 add-on Tegaderm
    TWB-103 is the primary therapeutics with the use of Tegaderm as a wound-site protection
  • Drug: Placebo+Tegaderm
    Placebo to TWB-103 with the use of Tegaderm as a wound-site protection
Study Arms  ICMJE
  • Experimental: Treatment Group
    TWB-103 add-on Tegaderm
    Intervention: Drug: TWB-103 add-on Tegaderm
  • Placebo Comparator: Control Group
    Placebo+Tegaderm
    Intervention: Drug: Placebo+Tegaderm
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2016)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

A patient is eligible for the study if all of the following apply:

  1. Female/male patients, aged 20-65 years old
  2. 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.
  3. 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%.
  4. 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
  5. Both male and female patients must agree to use highly effective contraceptives from signing informed consent to 30 days after the last dose administration.
  6. Willing to comply with the study protocol and to sign the Informed Consent Form

Any patient meeting any of the exclusion criteria will be excluded from study participation.

  1. 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.
  2. 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).
  3. Patients who are currently receiving or have received the following treatments within 4 weeks prior to study entry are excluded from the study:

    1. systemic or inhaled corticosteroids or immunosuppressant agents; or
    2. 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.
  4. Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
  5. Hematologic disease, malignancy or hypo-immunity.
  6. History of HIV or congenital immunodeficiency.
  7. History of alcoholism or drug abuse.
  8. Have used any tobacco product within 1 week prior to Day 0.
  9. Patients previously treated with any cell-based product, including autologous tissue at the treatment site.
  10. Received an investigational drug, device or biological/bioactive treatment within 30 days prior to Screening Visit.
  11. Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the trial treatment.
  12. History of sensitivity to bovine or porcine origin materials, or human serum albumin.
  13. DSWs located in the face, over joints, lower legs or the buttocks
  14. Any of the following hematologic abnormalities: (Hemoglobin < 10.0 g/dL, ANC < 1,500/μL, platelets < 75,000 /μL)
  15. 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)
  16. DSWs in area with active skin infection or with skin condition that is considered highly susceptible to infection judged by the investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sean Chen, Ph.D. 886-3-5670399 sean.chen@tw-bio.com
Listed Location Countries  ICMJE Japan,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02737748
Other Study ID Numbers  ICMJE 16-FDF-C001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Transwell Biotech Co., Ltd.
Study Sponsor  ICMJE Transwell Biotech Co., Ltd.
Collaborators  ICMJE A2 Healthcare Taiwan Corporation
Investigators  ICMJE
Principal Investigator: Niann-Tzyy Dai, MD, PhD. Tri-Service General Hospital
PRS Account Transwell Biotech Co., Ltd.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP