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The Protective Effect for Liver Organ in Patients With Anti-TB Drugs Using of Acetylcysteine (NAC)

Primary Purpose

Protective Effect in TB-DIH, TB-DIH Means: Drug Induced Liver Function Abnormalities

Status
Unknown status
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Acteylcysteine
Sponsored by
Far Eastern Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Protective Effect in TB-DIH focused on measuring tuberculosis, acetylcysteine, hepatotoxicity

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. new diagnosed to have tuberculosis
  2. age >20 years -

Exclusion Criteria:

  1. acute hepatitis in a previous one year
  2. TB drugs induced urticaria or Steven-Johnson syndrome
  3. life less than one year due to advanced cancer status
  4. non-tuberculosis mycobacteria，NTM patients
  5. HIV patients
  6. patients can not cooperate
  7. Allergic reaction for NAC

Sites / Locations

  • Far Eastern Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

NAC 1200 mg

NAC 2400 mg

NAC 0 mg

Arm Description

patients with add NAC (600) 1# bid use per day during the study period

patients with add NAC (600) 2# bid use per day during the study period

patients with add NAC (600) 0# (placebo) use per day during the study period

Outcomes

Primary Outcome Measures

the incidence of DIH
the rate for

Secondary Outcome Measures

the incidence for other side effects
side effects including GI upset, blurred vision, neuropathy, renal organ damage

Full Information

First Posted
August 31, 2016
Last Updated
September 9, 2016
Sponsor
Far Eastern Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02889757
Brief Title
The Protective Effect for Liver Organ in Patients With Anti-TB Drugs Using of Acetylcysteine (NAC)
Official Title
the Safety and Effect in TB Patients With NAC
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
June 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Far Eastern Memorial Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Animal studies have shown that INH-RIF-induced oxidative injury can be prevented by supporting the cellular antioxidant defense mechanism by N-acetylcysteine (NAC). However, there are few published data and large sample sizes regarding the protective effect of NAC against hepatotoxicty induced by anti-TB drugs in humans, to our knowledge. Therefore, the investigators designed a clinical trial with the aim to see whether NAC could protect against anti-TB drug-induced hepatotoxicity (DIH)
Detailed Description
Isoniazid (INH), rifampicin (RIF), and pyrazinamide (PZA), the first-line drugs used for tuberculosis (TB) chemotherapy, are associated with hepatotoxicity. A high rate of hepatotoxicity has been reported in some developing countries compared with advanced countries with a similar dose schedule. Sharifzadeh et al. reported an incidence of 27.7% in Iran. The reasons for this higher rate of hepatotoxicity are not completely clear. Ethnic variations, advanced age, female sex, alcoholism, underlying liver disease, acetylator phenotype, hepatitis B and C virus, HIV infection, extensive pulmonary parenchymal disease, and hypoalbuminemia have been observed to be the risk factors for the development of drug-induced hepatotoxicity (DIH) because of anti-TB treatment. The mechanism of DIH induced by anti-TB treatment is not yet fully understood. Sodhi et al. proposed oxidative stress as one of the likely mechanisms for INH-RIF-induced hepatic injury. It is well established that by augmenting a cellular antioxidative defense system, especially nonprotein thiols, that is, glutathione (GSH), cells can be protected against oxidative injuries produced by various drugs and chemicals. The study will be performed with randomized trial for assessment and protective effects over liver function in patients receiving anti-TB agents and using NAC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Protective Effect in TB-DIH, TB-DIH Means: Drug Induced Liver Function Abnormalities
Keywords
tuberculosis, acetylcysteine, hepatotoxicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NAC 1200 mg
Arm Type
Experimental
Arm Description
patients with add NAC (600) 1# bid use per day during the study period
Arm Title
NAC 2400 mg
Arm Type
Experimental
Arm Description
patients with add NAC (600) 2# bid use per day during the study period
Arm Title
NAC 0 mg
Arm Type
Placebo Comparator
Arm Description
patients with add NAC (600) 0# (placebo) use per day during the study period
Intervention Type
Drug
Intervention Name(s)
Acteylcysteine
Intervention Description
randomized into three arms
Primary Outcome Measure Information:
Title
the incidence of DIH
Description
the rate for
Time Frame
during the 6 months treatment
Secondary Outcome Measure Information:
Title
the incidence for other side effects
Description
side effects including GI upset, blurred vision, neuropathy, renal organ damage
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: new diagnosed to have tuberculosis age >20 years - Exclusion Criteria: acute hepatitis in a previous one year TB drugs induced urticaria or Steven-Johnson syndrome life less than one year due to advanced cancer status non-tuberculosis mycobacteria，NTM patients HIV patients patients can not cooperate Allergic reaction for NAC
Facility Information:
Facility Name
Far Eastern Memorial Hospital
City
Taipei
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Protective Effect for Liver Organ in Patients With Anti-TB Drugs Using of Acetylcysteine (NAC)

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