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

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ClinicalTrials.gov Identifier: NCT03471988
Recruitment Status : Recruiting
First Posted : March 21, 2018
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Asahi Kasei Pharma Corporation

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Deep Mycosis Drug: AK1820 Drug: Voriconazole Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multi-center, Open Label Study to Evaluate Safety and Efficacy of AK1820 for Treatment of Adult Japanese Patients With Deep Mycosis
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021


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





Primary Outcome Measures :
  1. 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). ]

Secondary Outcome Measures :
  1. 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. ]
  2. 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. ]
  3. 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. ]
  4. All-cause mortality. [ Time Frame: Through 28 days after the last dose of study drug (up to approximately Day 112). ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471988


Contacts
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Contact: Asahi Kasei Pharma Corporation ct-info@om.asahi-kasei.co.jp

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

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Responsible Party: Asahi Kasei Pharma Corporation
ClinicalTrials.gov Identifier: NCT03471988     History of Changes
Other Study ID Numbers: AK1820-301
First Posted: March 21, 2018    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asahi Kasei Pharma Corporation:
deep mycosis
aspergillosis
mucormycosis
cryptococcosis
isavuconazonium sulfate
isavuconazole
AK1820
Cresemba
Additional relevant MeSH terms:
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Cytochrome P-450 CYP3A Inhibitors
Mycoses
Voriconazole
Isavuconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs