Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis

Asahi Kasei Medical

Status and phase: Completed; Phase 3

Conditions: Deep Mycosis

Treatments: Drug: Voriconazole; Drug: AK1820

Study type: Interventional

Funder types: Industry

Identifiers

NCT03471988

AK1820-301

Details and patient eligibility

About

The objective of this study is to investigate the safety and efficacy of administering 372.6 mg of AK1820 (isavuconazonium sulfate) intravenously or orally to adult Japanese patients with deep mycosis. The primary endpoint is safety (percentage of patients with adverse events after starting the study treatment).

Enrollment: 103 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Patients must have the below proven, probable or possible deep mycosis;

  1. invasive aspergillosis
  2. chronic pulmonary aspergillosis
  3. mucormycosis
  4. cryptococcosis

• Female patients must be non-lactating and at no risk for pregnancy.

Main Exclusion Criteria:

• Women who are pregnant or breastfeeding.
• Patients with hypersensitivity to any of the components of the azole class of antifungals or the investigational product.
• Patients at high risk for QT/QTc prolongation, or patients with risk factors for torsades de pointes, or taking concomitant medications known to prolong the QT/QTc interval.
• Patients with a history of short QT syndrome.
• Patients with liver dysfunction at enrollment.
• Patients with moderate to severe kidney dysfunction at enrollment.
• Patients who receive prohibited concomitant drugs.
• Patients with any other fungal infection other than Aspergillus species, order Mucorales, or Cryptococcus species.
• Patients who are not expected to survive study duration.
• Patients with an underlying disease, complication or general condition that would complicate safety and efficacy evaluations.
• Patients with a history of taking voriconazole for deep mycosis and showing no response to this treatment.
• Patients taking systemic antifungals who are unable to stop taking these drugs during the study, or who are showing signs of improvement in their symptoms of deep mycosis as a result of these drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

AK1820

Experimental group

Description:

Participants will receive a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) or orally for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they will reach a treatment endpoint or for a maximum of 84 days.

Treatment:

Drug: AK1820

Voriconazole

Active Comparator group

Description:

Participants will receive a loading dose of voriconazole, 6 mg/kg every 12 hours IV or 300 mg every 12 hours orally for the first 24 hours, followed by a maintenance dose from Day 2 of 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they will reach a treatment endpoint or for a maximum of 84 days.

Treatment:

Drug: Voriconazole