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Clinical Trials List

Protocol NumberNAC600-TB-IIS

NCT Number(ClinicalTrials.gov Identfier)N/A

2017-02-06 - 2018-12-31

Phase IV

Recruiting4

ICD-10A15.0

Tuberculosis of lung

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

Trial Applicant

T-TOP Clinical Research Co., Ltd.
Sponsor

National Taiwan University Hospital
Trial scale

Taiwan Multiple Center
Update

2025/08/20

Investigators and Locations

Principal Investigator 鄭世隆 Division of Thoracic Medicine

Far Eastern Memorial Hospital

Co-Principal Investigator

王秉槐 Division of Thoracic Medicine
林祖權 Division of Thoracic Medicine
張晟瑜 Division of Thoracic Medicine

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ning-Hung Chen Division of Thoracic Medicine

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator kang-Yun LEE Division of Thoracic Medicine

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Audit

None

Principal Investigator HAO-CHIEN WANG Division of Thoracic Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Tuberculosis

Objectives

Isoniazid (INH), rifampicin (RIF), and pyrazinamide (PZA), 這三種是治療結核病所使用的第一線藥物治療的藥物。同時也跟藥物引起的肝毒性有息息相關。這種引發的藥物肝毒性曾經報導過使用相同的劑量在開發中國家引發的比例高於在已開發國家。在台灣，病患亦常常因為肝毒性以致於無法再繼續接受抗結核藥物治療，以致於結核病在台灣始終居高不下，實是很重要的公衛問題。乙酰半胱胺酸(Acetylcysteine, NAC)它通過分解粘蛋白複合物、核酸，將膿性成份及其它分泌物從粘稠變為透明而發揮強烈溶粘液作用，在臨床上是一種化痰藥物治療。此外NAC亦具有直接抗氧化作用，可作為一種特殊的解毒劑，因此NAC被認為是一種相當好的抗氧化藥物。在過去的研究中關於NAC是否有減少抗結核藥物引發肝毒性的保護效果上是非常少的探討與報導。因此，在此研究中，我們將探討在服用抗結核藥物的同時加上NAC的服用在這治療的期間是否有助於肝臟的保護及減少因結核藥物引發肝臟損傷的發生率。

Test Drug

Actein

Active Ingredient

Acetylcysteine

Dosage Form

Effervescent Tablet

Dosage

600mg

Endpoints

Primary Outcomes: Incidence of DIH in three groups
Secondary Outcomes:
1. sputum conversion to negative time (cavity/no cavity)
2. Resolute chest X-ray lesions
3. time to develop DIH
4. DIH severity
5. recovery time after holding TB drugs if patients develop DIH
6. other side effects evaluation: numbness, GI upset, blurred vision, renal toxicity

Inclution Criteria

主要納入條件：
1.為新診斷肺結核開始使用結核治療藥物的病人。
2.病患年紀大於20歲(含)

Exclusion Criteria

主要排除條件：
1.過去一年曾罹患急性肝炎病患者。
2.對於抗結核藥物有明顯藥物引發皮膚過敏者(urticaria or Steven-Johnson syndrome)
3.末期器官衰竭或惡性腫瘤患者，其存活時間未滿一年者。
4.非結核桿菌(non-tuberculosis mycobacteria，NTM)之感染患者。
5.HIV患者
6.無法同意及配合者
7.對於服用NAC過敏反應或不適者

The Estimated Number of Participants

Taiwan

400 participants
Global

0 participants