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

May 13, 2021 updated by: Asahi Kasei Pharma Corporation

A Phase 3, Multi-center, Open Label Study to Evaluate Safety and Efficacy of AK1820 for Treatment of Adult Japanese Patients With Deep Mycosis

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan
        • Research Site
      • Ibaraki, Japan
        • Research Site
      • Nagasaki, Japan
        • Research Site
    • Aichi
      • Nagakute, Aichi, Japan
        • Research Site
      • Nagoya, Aichi, Japan
        • Research Site
      • Seto, Aichi, Japan
        • Research Site
    • Fukuoka
      • Higashi-Ku, Fukuoka, Japan
        • Research Site
      • Minami-Ku, Fukuoka, Japan
        • Research Site
    • Gifu
      • Nagara, Gifu, Japan
        • Research Site
    • Hiroshima
      • Naka-Ku, Hiroshima, Japan
        • Research Site
    • Hokkaido
      • Asahikawa, Hokkaido, Japan
        • Research Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan
        • Research Site
      • Yokohama, Kanagawa, Japan
        • Research Site
    • Kumamoto
      • Chuo-Ku, Kumamoto, Japan
        • Research Site
    • Mie
      • Tsu, Mie, Japan
        • Research Site
    • Nagasaki
      • Isahaya, Nagasaki, Japan
        • Research Site
      • Sasebo, Nagasaki, Japan
        • Research Site
      • Ōmura, Nagasaki, Japan
        • Research Site
    • Nara
      • Tenri, Nara, Japan
        • Research Site
    • Oita
      • Yufu, Oita, Japan
        • Research Site
    • Okayama
      • Kurashiki, Okayama, Japan
        • Research Site
    • Okinawa
      • Nakagami, Okinawa, Japan
        • Research Site
    • Osaka
      • Abeno-Ku, Osaka, Japan
        • Research Site
      • Sakai, Osaka, Japan
        • Research Site
    • Saitama
      • Ōmiya, Saitama, Japan
        • Research Site
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan
        • Research Site
    • Tochigi
      • Shimotsuke, Tochigi, Japan
        • Research Site
    • Tokyo
      • Kiyose, Tokyo, Japan
        • Research Site
      • Minato-Ku, Tokyo, Japan
        • Research Site
      • Mitaka, Tokyo, Japan
        • Research Site
      • Ota-Ku, Tokyo, Japan
        • Research Site
      • Shinagawa-Ku, Tokyo, Japan
        • Research Site
      • Shinjuku-Ku, Tokyo, Japan
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AK1820
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.
Drug: AK1820

Only a switch from IV infusion (vial) to oral administration (capsule) will be permitted; a switch from oral administration to IV infusion will not be possible.

372.6 mg of AK1820 (isavuconazonium sulfate) is equivalent to 200 mg of isavuconazole.

Other Names: Cresemba, BAL8557
Active Comparator: Voriconazole
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.
Drug: Voriconazole

Only a switch from IV infusion (vial) to oral administration (tablet) will be permitted; a switch from oral administration to IV infusion will not be possible.

Other Name : VFend

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with adverse events between the first administration of investigational product and the end of Follow-up.
Time Frame: From the first study drug administration until 28 days after the last dose of study drug (up to approximately Day 112).
From the first study drug administration until 28 days after the last dose of study drug (up to approximately Day 112).

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with an overall outcome of success evaluated by the data review committee (DRC).
Time Frame: Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.
Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.
Percentage of participants with clinical, radiological and mycological response assessed by the DRC.
Time Frame: Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.
Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.
Percentage of participants with overall outcome, clinical, radiological and mycological response evaluated by investigator.
Time Frame: Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.
Day 42, Day 84 and End of Treatment* (maximum Day 84).*End of treatment (EOT) is defined as the last day of study drug treatment.
All-cause mortality.
Time Frame: Through 28 days after the last dose of study drug (up to approximately Day 112).
Through 28 days after the last dose of study drug (up to approximately Day 112).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asahi Kasei Pharma Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2018

Primary Completion (Actual)

April 21, 2021

Study Completion (Actual)

April 21, 2021

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

March 14, 2018

First Posted (Actual)

March 21, 2018

Study Record Updates

Last Update Posted (Actual)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AK1820-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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