A Prospective Interventional Study for CPA

JRCT ID: jRCTs071230121

Registered date:04/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Pulmonary Aspergillosis
• Date of first enrollment: 04/03/2024
• Target sample size: 90
• Study type: Interventional
• Intervention(s): Trough concentrations of isavuconazole in plasma for research.

Outcome(s)

Primary Outcome

-Adverse event incidences
-Adverse reaction incidences
-Percentages of patients able to continue treatment (by period)
-Percentages of patients who switched treatment (by cause)
-Percentages of patients who discontinued treatment (by cause)
-Time profiles of laboratory test results

Secondary Outcome

-Response rate with respect to overall outcome effect based on the results of assessment by the investigator or sub-investigator
-Response rates with respect to the effect on clinical symptoms and the effect on diagnostic imaging based on the results of assessment by the investigator or sub-investigator and the disappearance rate with respect to mycological effect
-All-cause mortality

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1 Patients who have personally provided written, informed consent to participate in the study.
2 Japanese men or women aged 18 years or older at the time of informed consent.
3 Patients on initial treatment for CPA or patients with relapsed CPA ([proven] or [probable]).
4 Patients changing from treatment with other drugs (patients who are intolerant to other drugs or whose symptoms and imaging findings of CPA are not improving)([proven] or [probable]).
5 Patients for whom the initiation of ISAV treatment has been decided by the investigator or sub-investigator.

Exclude criteria

1 Patients for whom ISAV is contraindicated in accordance with the Japanese package insert.
2 Patients with congenital short QT syndrome.
3 Patients with severe hepatic impairment (Child-Pugh C).
4 Female patients who are pregnant or nursing.
5 Patients who are unlikely to survive until study completion.
6 Patients whose personal circumstances are not conducive to long-term treatment.
7 Patients with a causative fungus other than Aspergillus species.
8 Patients who have been treated with ISAV previously and had failed to respond or were intolerant to the treatment.
9 Patients who have received ISAV within the last 3 months.
10 Patients participating in an ongoing interventional clinical trial.
11 Patients who have participated in the study in the past.
12 Any other patients deemed unsuitable to participate in the study by the investigator or sub-investigator.

Related Information

• Primary Sponsor: Izumikawa Koichi
• Secondary Sponsor: ASAHI KASEI PHARMA Corp.