臨床研究等提出・公開システム

A multicenter clinical study to evaluate the efficacy and safety of monotherapy with benznidazole or nifurtimox in patients with Chagas disease, or switching from monotherapy with benznidazole to monotherapy with nifurtimox

Specific Clinical Study of Benznidazole and Nifurtimox for Chagas Disease

Yamaoto Kei

Japan Institute for Health Security National Center for Global Health and Medicine

1-21-1 Toyama Shinjyuku-ku Tokyo

yamamoto.k@jihs.go.jp

Yamamoto Kei

Japan Institute for Health Security National Center for Global Health and Medicine

1-21-1 Toyama Shinjyuku-ku Tokyo

+81-332017181

yamamoto.k@jihs.go.jp

Recruiting

July. 01, 2025

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Patients who have been confirmed to have Chagas disease using one of the following methods, regardless of gender, nationality or race.
<1>The protozoa were detected by optical microscopy of blood smears (thin or thick layer) or tissue samples.
<2> The results of nucleic acid amplification tests such as PCR using blood or other tissue samples were positive.
(3) Screening was carried out using enzyme-linked immunosorbent assay (ELISA) or immunochromatography, and the results of radioimmunoprecipitation assay (RIPA) or other antibody tests were positive.
(This does not include the results of screening tests using immunochromatography carried out by organizations other than the organization in charge of the test)
2. The subject weighed at least 2.5 kg at the time of acquisition.
3. Patients who can provide written consent for participation in the research, depending on the patient's age, etc.

1. Patients who are hypersensitive to the drug in question
2. Pregnant, lactating, or possibly pregnant patients, or patients who do not consent to discontinuing breast-feeding during the study period
3. Patients who are diagnosed with alcohol dependence and are receiving treatment at the time of obtaining consent
4. Patients who do not consent to abstaining from alcohol during the period of taking the drug and for three days after finishing taking it
5. Patients with severe hepatic insufficiency
6. Patients with severe renal failure (serum creatinine of 3 mg/dL or more on a constant basis, or dialysis)
7. Patients who have taken disulfiram within 2 weeks of starting the medication
8. Patients with chronic cardiomyopathy (NYHA classification III or higher) with confirmed dilated cardiomyopathy
9. Patients with severe gastrointestinal damage (severe megacolon, severe megaesophagus)
10. Patients who are unable to agree to contraception during the period of administration of benznidazole and for 5 days after the end of administration
11. Patients who are unable to agree to contraception during the period of administration of nifurtimox and for 3 months after the end of administration in the case of male patients, and for 6 months after the end of administration in the case of female patients. If the patient is unable to agree to the contraception period for nifurtimox, nifurtimox will not be administered and the patient will be considered to have withdrawn from the study.
12. Patients who the principal investigator or subinvestigator judges to be inappropriate for participation in this study

Both

Chagas

Treatment with un-licensed medicine

1) If the blood PCR test is positive before treatment begins: the PCR test is negative one year after treatment begins
2) If the blood PCR test is negative before treatment begins: the antibody titer decreases (by more than twofold) or becomes negative two years after treatment begins

1) Rate of decline in serum antibodies
2) Presence or absence of cardiac or intestinal complications 2 years after the start of treatment
3) Presence or absence of adverse events and adverse events leading to discontinuation of treatment
4) Concordance between screening and confirmatory tests (antibody tests)

+81-3-3202-7181

Mar. 28, 2025

No

None