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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 drugs

Incidence 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

Page last updated: August 23, 2015

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