drugset
drugset / Trial / NCT02737748

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

NCT02737748 ↗

Phase 1/2 Completed 48 enrolled Transwell Biotech Co., Ltd. A2 Healthcare Taiwan Corporation · collab
RandomizedParallel-groupTriple-blindTreatment

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

Timeline

Start
2017-07-06
Primary completion
2021-05-07
Completion
2021-05-07

Outcome

Mixed primary results

registry analysis (other test); TWB-103 Group vs Placebo Group; p = 0.2217; Cochran-Mantel-Haenszel NCT02737748 ↗

registry analysis (other test); TWB-103 Group vs Placebo Group; p = 0.0324; Cochran-Mantel-Haenszel NCT02737748 ↗

registry COUNT_OF_PARTICIPANTS TWB-103 Group: 19 Participants NCT02737748 ↗

registry COUNT_OF_PARTICIPANTS Placebo Group: 14 Participants NCT02737748 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject TWB-103 Unknown — —

Indications

No indication recorded.