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Protocol NumberNDMC HUEXC030-TB1

2012-07-01 - 2019-08-31

Phase II/III

Terminated13

A Randomized, Double-Blind, Active Drug Controlled Study to Assess the Efficacy of HUEXC030 as Add-on Excipient to Eradicate Anti-Tuberculosis Drugs Induced Liver Injury in Subjects with Pulmonary Tuberculosis

  • Trial Applicant

    Orient PHARMA Co., Ltd.

  • Sponsor

    National Defense Medical Center

  • Trial scale

    Taiwan Multiple Center

  • Update

    2025/08/19

Investigators and Locations

Principal Investigator Inn-Wen Chong Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 彭萬誠 Division of General Internal Medicine
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Chun-Nin Lee Division of Thoracic Medicine
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 黃 伊文 Division of Thoracic Medicine
Chang-Hua Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 吳燿光 Division of Thoracic Medicine
Taipei Tzu Chi Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator WEI-JUIN SU Division of Thoracic Medicine
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Shih-Wei Lin Division of Thoracic Medicine
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Meng-Jer Hsieh Division of Thoracic Medicine
Chiayi Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 林慶雄 Division of Thoracic Medicine
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Wei- Chang Huang Division of Thoracic Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator Susan Shin-Jung Lee Division of Infectious Disease
Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 黃俊凱 Division of Infectious Disease
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 方文豐 Division of Thoracic Medicine
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Condition/Disease

A Randomized, Double-Blind, Active Drug Controlled Study to Assess the Efficacy of HUEXC030 as Add-on Excipient to Eradicate Anti-Tuberculosis Drugs Induced Liver Injury in Subjects with Pulmonary Tuberculosis

Objectives

The purpose of this study is to evaluate whether the hepatotoxic side effects of subjects suffering from tuberculosis after taking the anti-tuberculosis drug combined with HUEXC030 are significantly lower than the anti-tuberculosis drugs of the control group, and the efficacy of the new drug treatment is comparable to that of the control group .

Test Drug

Isoniazid tablet formulated with excipient HUEXC030

Active Ingredient

HUEXC030
Isoniazid

Dosage Form

tablet

Dosage

100
200

Endpoints

Compare the occurrence of hepatotoxic side effects of the anti-TB drug combined with HUEXC030 and the anti-TB drug in the control group after 8 weeks

Inclution Criteria

Be at least 20 years old.
2. The body weight is greater than 40 kg.
3. A confirmed tuberculosis patient who meets at least one of the following conditions:
a. Chest X-ray or CT scan reveals tuberculosis symptoms
b. After two or more sputum smears, acid-resistant staining microscopy is positive
c. Confirmed by sputum culture to be infected with tuberculosis bacilli
d. At least one sputum smear is positive for acid-resistant staining and confirmed by nucleic acid amplification test to be infected with Mycobacterium tuberculosis
e. At least one sputum smear is positive for acid-resistant staining microscopy and shows tuberculosis on chest X-ray, and the host judges that the patient needs to be treated for tuberculosis cases.
f. The moderator judged that the patient was diagnosed with tuberculosis.
4. This course of treatment has not received more than 3 doses of first-line anti-tuberculosis drug treatment.
5. Appropriate medical history and physical examination records are available before joining the trial.
6. The liver function index of the physical examination shows that it meets the following acceptable range. !
i. AST and ALT are less than 3 times the upper limit of normal
ii. Total serum bilirubin <2.0 mg/dL
If the subject is diagnosed as a carrier of hepatitis B, hepatitis C, or chronic hepatitis, and the condition is stable during the 28-day screening period, they can be included in the trial.
7. The renal function index of physical examination shows that it meets the following acceptable range. !
i. Glomerular Filtration Rate (eGFR) ≥ 30mL /min/1.73m2
8. The subject agrees to sign the subject consent form for this trial.

Exclusion Criteria

Before participating in the trial, there was drug abuse or alcohol addiction, and those who were confirmed to have the following diseases: extrapulmonary tuberculosis without pulmonary disease, HIV, liver cancer, liver cirrhosis, any other liver diseases that may seriously affect liver function, the test drug isoniazid , Rifampin, ethambutol, pyrazinamide or chemicals with similar structures to sugar alcohols (for example: HUEXC030) will cause allergies. After starting TB drug treatment, antiretroviral or oral steroid drugs will be used, and sputum smear bacteriological culture or Molecular biological identification revealed that the infected Mycobacterium tuberculosis is resistant to isoniazid, rifampin, ethambutol or pyrazinamide, unwilling to accept research procedures, or no time to attend necessary research clinics, pregnancy or lactation, and spouse planning to become pregnant or unable to cooperate Use effective contraceptive measures other than oral drugs during the whole process of the study, and there are other serious diseases that the host believes that the subjects are not suitable for participating in this trial.

The Estimated Number of Participants

  • Taiwan

    556 participants

  • Global

    0 participants

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