NCT00294489Unknown不适用
Methacetin Breath Test in HCV Patients With Normal and Near-Normal ALT
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 1
研究概览
简要总结
A relatively large proportion of patients with chronic HCV infection have normal or mildly elevated ALT. Many of these patients are not being treated, and are not being sent for a liver biopsy. The present study will determine the ability of Methcetin BreathID Test(MBIT) to detect those patients who will be candidates for anti-viral treatment, as an alternative measure for liver biopsy in decision-making prior to treatment in clinical hepatology.
详细描述
The rational for using MBIT in the management of HCV in patients with persistently normal (and slightly elevated) ALT:
- If MBIT is impaired, this indicates fibrosis >2: a trigger to begin treatment
- This strategy will enable treating patients with relatively severe disease that was not detected by biopsy.
- HMOs recognize the cost-effectiveness of anti-viral therapy in these patients, as a means of prevention of deterioration, cirrhosis and HCC.
- If MBIT indicates low fibrosis => treatment may be deferred, and follow-up is performed to detect any possible degradation that will indicate need for treatment.
- Today the AASLD guidelines allow for treatment of HCV RNA+ patients with normal ALT. In view of the limited effectivity of therapy, its cost and side effects, there are likely to be many individuals in whom therapy can be safely deferred, leading to cost saving.
- MBIT may replace the need of liver biopsy for decision- making in HCV.
- Even in patients with genotype 1 and elevated ALT, or with risk of side effects, treatment may be delayed in low fibrosis (e.g. <2).
GOAL:
• To assess the ability of the MBIT to improve the management of patients for liver disorders
AIM:
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women>18
- •Patients with HCV RNA+ above 105 copies Patients with normal liver enzymes on two tests 3 months apart, or up to <X1.5 of upper normal
- •Patients with biopsy proven HCV or (9 months prior to test with no anticipated changes in liver disease since biopsy).
排除标准
- •Other liver disorders.
- •Active infections.
- •Use of drugs that are known to induce/suppress P4501A2
- •Pulmonary diseases
- •Consumption of >20cc alcohol a day prior to the test.
研究者
研究点 (1)
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