MedTrace Logo

A Study of TQ05105 Tablets in Subjects With Glucocorticoid-Refractory Acute Graft-Versus-Host Disease (aGVHD)

NCT04941404 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-12-08

No results posted yet for this study

Summary

This is an open-label,single arm,Phase Ib study,in order to evaluate the safety,tolerability, preliminary efficacy and pharmacokinetics of TQ05105 tablets in subjects with Glucocorticoid-Refractory aGVHD

Conditions

  • Glucocorticoid-Refractory aGVHD

Interventions

DRUG

TQ05105 tablets

Participants began oral administration of TQ05105 tablets at 10 mg twice daily (BID),followed by 5 mg or 15 mg BID depending on the situation of the study. twice daily in 28-day cycle until disease progression/intolerance occurs or the sponsor terminates the study.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2023-07-10
Completion
2024-12-24

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941404 on ClinicalTrials.gov