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Efficacy of HUEXC030 in Subjects With Pulmonary Tuberculosis

NCT02467608 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 557

Last updated 2022-06-15

No results posted yet for this study

Summary

Assess the Efficacy of HUEXC030 as Add-on Excipient to Eradicate Anti-Tuberculosis Drugs Induced Hepatic Injury ( ATDH ) in Subjects with Pulmonary Tuberculosis

Conditions

  • Pulmonary Tuberculosis

Interventions

DRUG

Isoniazid with HUEXC030 and RZE

Subjects will receive oral study drug daily in accordance with the following regimen, that is, INH, RMP, PZA, and EMB for the first 2 months followed by INH, RMP and EMB (if medically indicated) daily for 4 additional months

DRUG

HRZE

the same as experimental group,without the excipient of HUEXC030 only

Sponsors & Collaborators

  • National Defense Medical Center, Taiwan

    collaborator OTHER

  • National Research Program for Biopharmaceuticals, Taiwan

    collaborator OTHER

  • Orient Pharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yu-Pu Hu, PhD · National Defense Medical Center, Taiwan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-06
Primary Completion
2019-01-09
Completion
2019-01-09

Countries

  • Taiwan

Study Locations

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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 NCT02467608 on ClinicalTrials.gov