Efficacy of HUEXC030 in Subjects With Pulmonary Tuberculosis
Information source: Orient Pharma Co., Ltd.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Tuberculosis
Intervention: Isoniazid with HUEXC030 and RZE (Drug); HRZE (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
Sponsored by: Orient Pharma Co., Ltd. Official(s) and/or principal investigator(s): Yu-Pu Hu, PhD, Study Chair, Affiliation: National Defense Medical Center, Taiwan
Overall contact: I-Chan Lee, MS, Phone: +886-2-2325-7621, Ext: 2928, Email: ichan.lee@oppharma.com
Summary
Assess the Efficacy of HUEXC030 as Add-on Excipient to Eradicate Anti-Tuberculosis Drugs
Induced Hepatic Injury ( ATDH ) in Subjects with Pulmonary Tuberculosis
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: ALT change from baseline to the 8 weeks of study treatment
Secondary outcome: Incidence of ATDH in high risk genotype subjects treated with investigational drugsIncidence of ATDH in high risk genotype subjects treated with investigational drugs Percentage of patients cured by the end of treatment Percentage of patients cured by the end of treatment The overall reduced incidence of ATDH in subjects treated with investigational drugs The lowering average level of liver function tests
Detailed description:
The study drug is Isoniazid formulated with HUEXC030 as excipient for eradicating ATDH,
whereas the reference control is Isoniazid formulated with inactive excipient. Subjects who
fulfill all the entry criteria and have written informed consent will be enrolled to the
study. Eligible subjects will be randomized in a 1: 1 ratio to receive study drug or
reference control drug. Subjects will be genotyped according to a selected panel of single
nucleotide polymorphisms (SNPs) and categorized into high risk or low risk groups for
occurring ATDH via a specific haplotype consists of CYP2E1 and NAT2 SNPs. Based on an
extensive study result during 2007 to 2011,the estimated frequency for patients bearing high
risk genotypes in Taiwanese population is around 25%. Approximately 352 subjects will be
enrolled for genotype screening in order to recruit 88 high risk subjects for each of 44
subjects in the intervention and control arms.
Subjects who are stratified as high risk groups will be administered the test drug or
reference control drugs oral daily for 6 months or until treatment completion, i. e.
bacteriologically confirmed negative of active M. tuberculosis. Subjects who are of low risk
genotype will be removed from study after 8 weeks of study treatment, then return to
conventional TB medication under the care of their investigator for at least one follow-up
visit at 4 weeks after the End of Study.
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
I-Chan Lee, MS, Phone: +886-2-2325-7621, Ext: 2928, Email: ichan.lee@oppharma.com
Changhua Christian Hospital, Changhua, Taiwan; Recruiting Ching-Hsiung Lin, MD PhD
Changhua Hosiptal Ministry of Health And Welfare, Changhua, Taiwan; Recruiting Yi-Wen Huang, MD PhD
Chang Gung Memorial Hospital, ChiaYi, ChiaYi, Taiwan; Recruiting Meng-Jer Hsieh, MD
Chang Gung Memorial Hospital ,Linkou, Linkou, Taiwan; Recruiting Shih-Wei Lin, MD
Buddhist Tzu Chi General Hospital, Taipei, Taiwan; Recruiting Yao-Kuang Wu, MD
Cheng Hsin General Hospital, Taipei, Taiwan; Recruiting Wei-Teing Chen, MD PhD
National Taiwan University Hospital, Taipei, Taiwan; Recruiting Jann-Yuan Wang, MD PhD
Taipei City Hospital, Taipei, Taiwan; Active, not recruiting
Taipei Medical University-Shuang Ho Hospital, Taipei, Taiwan; Recruiting Chun-Nin Lee, MD
Taipei Veterans General Hospital, Taipei 112, Taiwan; Recruiting Wei-Jhen Su, MD
Taipei Wanfang Hospital, Taipei, Taiwan; Recruiting Ming-Chih Yu, MD
Tapei Medical University Hospital, Taipei, Taiwan; Recruiting Chi-Li Chung, MD PhD
Tri-Service General Hospital, Taipei 11490, Taiwan; Recruiting Wann-Chemg Pemg, MD PhD
Additional Information
Starting date: December 2012
Last updated: June 5, 2015
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