Efficacy of HUEXC030 in Subjects With Pulmonary Tuberculosis

• Status: Suspended
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Orient Pharma Co., Ltd.
• Collaborators: National Defense Medical Center, Taiwan; National Research Program for Biopharmaceuticals, Taiwan; National Research Program for Biopharmaceutics, Taiwan
• Treatments: Isoniazid

Criteria

Main inclusion criteria:

1. A definite case of pulmonary TB

2. Patient who is exposed to 3 or less doses of first-line anti-TB drug treatment for current disease.

3. Age ≥ 20 years

4. Have well documented baseline liver function tests that indicates patient's adequate liver function for enrollment to study.

i. AST and ALT < 3x ULN ii. total serum bilirubin < 2.0 mg/dL

Main Exclusion Criteria:

1. Have alcoholic liver disease or habitual alcohol consumption > 30 g/day for more than one year

2. Previously diagnosed of:

i. extra-pulmonary TB without concomitant lung invasion ii. HIV iii. liver malignancy iv. liver cirrhosis v. any other systemic diseases that may cause liver dysfunction

3. Documented history of serious allergic reaction or resistance to isoniazid, rifampicin, ethambutol, pyrazinamide, sugar alcohols or any structurally related compounds

4. Subjects who will be using the following therapies after TB treatment starts:

i. antiretroviral agents ii. oral corticosteroids

5. Subjects are pregnant or lactating

6. Subjects with child-bearing potential who are not committed to take reliable contraception during the participation of the study and at least 4 weeks after the end of the study treatment

7. Subjects with any other serious disease considered by the investigator not in the condition to enter into the trial