Efficacy of HUEXC030 in Subjects With Pulmonary Tuberculosis
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
1 other identifier
interventional
557
1 country
18
Brief Summary
Assess the Efficacy of HUEXC030 as Add-on Excipient to Eradicate Anti-Tuberculosis Drugs Induced Hepatic Injury ( ATDH ) in Subjects with Pulmonary Tuberculosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2012
Longer than P75 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 6, 2012
CompletedFirst Submitted
Initial submission to the registry
May 31, 2015
CompletedFirst Posted
Study publicly available on registry
June 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 9, 2019
CompletedJune 15, 2022
June 1, 2022
6.1 years
May 31, 2015
June 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ALT change from baseline to the 8 weeks of study treatment
The primary efficacy endpoint is the time-interval weighted area under the curve (AUC) of change from baseline in serum ALT, primarily in patients with high risk genotypes. The area under ALT change curve was estimated using the linear trapezoidal rule. The AUC was a measure of cumulative ALT differences from baseline to the 8 weeks of double-blind treatment period.
8 weeks
Secondary Outcomes (6)
Incidence of ATDH in high risk genotype subjects treated with investigational drugs
8 weeks
Incidence of ATDH in high risk genotype subjects treated with investigational drugs
26 weeks
Percentage of patients cured by the end of treatment
8 weeks
Percentage of patients cured by the end of treatment
26 weeks
The overall reduced incidence of ATDH in subjects treated with investigational drugs
26 weeks
- +1 more secondary outcomes
Study Arms (2)
Isoniazid with HUEXC030 and RZE
EXPERIMENTALSubjects who are genotyped as high risk group will be receiving 2 months of intensive treatment comprised of 4 drugs (Isoniazid with HUEXC030 \[H\], rifampin \[R\], pyrazinamide \[Z\] and ethambutol \[E\]), followed by 4 months of continual chemotherapy consist of Isoniazid, Rifampin (2HRZE/4HR regimen). Subjects who are of low risk genotype will be removed from study after 8 weeks of study treatment, then return to conventional TB medication at least one follow-up visit at 4 weeks after the end of study treatment visit. Dosage is as below: Isoniazid with Isoniazid(H):300mg/600mg daily, rifampin \[R\]: 450\~600mg daily, pyrazinamide \[Z\]; 1000\~2000mg daily and ethambutol \[E\]: 800-1600mg daily)
Isoniazid
OTHERSubjects who are genotyped as high risk group will be receiving 2 months of intensive treatment comprised of 4 drugs (Isoniazid \[H\], rifampin \[R\], pyrazinamide \[Z\] and ethambutol \[E\]), followed by 4 months of continual chemotherapy consist of Isoniazid, Rifampin (2HRZE/4HR regimen). Subjects who are of low risk genotype will be removed from study after 8 weeks of study treatment, then return to conventional TB medication at least one follow-up visit at 4 weeks after the end of study treatment visit. Dosage is as below: Isoniazid (H):300mg daily, rifampin \[R\]: 450\~600mg daily, pyrazinamide \[Z\]; 1000\~2000mg daily and ethambutol \[E\]: 800-1600mg daily)
Interventions
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
the same as experimental group,without the excipient of HUEXC030 only
Eligibility Criteria
You may qualify if:
- A definite case of pulmonary TB
- Patient who is exposed to 3 or less doses of first-line anti-TB drug treatment for current disease.
- Age ≥ 20 years
- 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
You may not qualify if:
- Have alcoholic liver disease or habitual alcohol consumption \> 30 g/day for more than one year
- 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
- Documented history of serious allergic reaction or resistance to isoniazid, rifampicin, ethambutol, pyrazinamide, sugar alcohols or any structurally related compounds
- Subjects who will be using the following therapies after TB treatment starts:
- i. antiretroviral agents ii. oral corticosteroids
- Subjects are pregnant or lactating
- 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
- Subjects with any other serious disease considered by the investigator not in the condition to enter into the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Changhua Christian Hospital
Changhua, Taiwan
Changhua Hosiptal Ministry of Health And Welfare
Changhua, Taiwan
Chang Gung Memorial Hospital, ChiaYi
Chiayi City, Taiwan
Chang Gung Memorial Hospital, Kaohsiung
Kaohsiung City, Taiwan
E-DA Hospital, I-Shou University
Kaohsiung City, Taiwan
Kaohsiung Medical University Hospital
Kaohsiung City, Taiwan
Kaohsiung Veterans General Hospital
Kaohsiung City, Taiwan
Chang Gung Memorial Hospital ,Linkou
Linkou District, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Tri-Service General Hospital
Taipei, 11490, Taiwan
Buddhist Tzu Chi General Hospital
Taipei, Taiwan
Cheng Hsin General Hospital
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei City Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Medical University-Shuang Ho Hospital
Taipei, Taiwan
Taipei Wanfang Hospital
Taipei, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yu-Pu Hu, PhD
National Defense Medical Center, Taiwan
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2015
First Posted
June 10, 2015
Study Start
December 6, 2012
Primary Completion
January 9, 2019
Study Completion
January 9, 2019
Last Updated
June 15, 2022
Record last verified: 2022-06