Deep MycosisPhase 3NCT03471988
Clinical Study of AK1820 (Isavuconazonium Sulfate) for the Treatment of Deep Mycosis
A Phase 3 study testing AK1820 and Voriconazole in people with Deep Mycosis, run by Asahi Kasei Therapeutics Corporation at 33 sites in Japan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Deep Mycosis
- What is being tested?
- AK1820 and Voriconazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 33 sitesJapan
- Study dates
- 16 Apr 2018to 21 Apr 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Main Inclusion Criteria:
- Patients must have the below proven, probable or possible deep mycosis;
- invasive aspergillosis
- chronic pulmonary aspergillosis
- mucormycosis
- 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 locations and contacts
33 sites in 1 country.
33 sites in 1 country
Japan33 sites
Research site
Abeno-Ku, Osaka
Research site
Asahikawa, Hokkaido
Research site
Chiba
Research site
Chuo-Ku, Kumamoto
Research site
Hamamatsu, Shizuoka
Research site
Higashiku, Fukuoka
Research site
Ibaraki
Research site
Isahaya, Nagasaki
Research site
Kawasaki, Kanagawa
Research site
Kiyose, Tokyo
Research site
Kurashiki, Okayama-ken
Research site
Minamiku, Fukuoka
Research site
Minato-Ku, Tokyo
Research site
Mitaka, Tokyo
Research site
Nagakute, Aichi-ken
Research site
Nagara, Gifu
Research site
Nagasaki
Research site
Nagoya, Aichi-ken
Research site
Naka-Ku, Hiroshima
Research site
Nakagami, Okinawa
Research site
Ōmiya, Saitama
Research site
Ōmura, Nagasaki
Research site
Ōta-ku, Tokyo
Research site
Sakai, Osaka
Research site
Sasebo, Nagasaki
Research site
Seto, Aichi-ken
Research site
Shimotsuke, Tochigi
Research site
Shinagawa-Ku, Tokyo
Research site
Shinjuku-Ku, Tokyo
Research site
Tenri, Nara
Research site
Tsu, Mie-ken
Research site
Yokohama, Kanagawa
Research site
Yufu, Oita Prefecture
About this study
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
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).
- Conditions
- Deep Mycosis
- Being tested
- AK1820, Voriconazole
- Keywords
- deep mycosis, aspergillosis, mucormycosis, cryptococcosis, isavuconazonium sulfate, isavuconazole, AK1820, Cresemba
- Medical subject headings
- Aspergillosis, Mucormycosis, Cryptococcosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK1820Drug
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
VoriconazoleDrug
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
| Study group | Role | What they receive |
|---|---|---|
| AK1820 | Experimental | 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. Receives: Drug: AK1820 |
| Voriconazole | Active comparator | 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. Receives: Drug: Voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with adverse events between the first administration of investigational product and the end of Follow-up.
Measured: From the first study drug administration until 28 days after the last dose of study drug (up to approximately Day 112).
Secondary outcomes (4)
Percentage of participants with an overall outcome of success evaluated by the data review committee (DRC).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through 28 days after the last dose of study drug (up to approximately Day 112).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start16 Apr 2018
- Primary completion21 Apr 2021
- Study completion21 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Deep MycosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asahi Kasei Therapeutics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471988
- Sponsor's protocol ID
- AK1820-301
- Status last verified
- Jan 2021
- First submitted
- 26 Feb 2018
- Last updated
- 14 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kohno S, Izumikawa K, Takazono T, Miyazaki T, Yoshida M, Kamei K, Ogawa K, Taniguchi S, Akashi K, Tateda K, Mukae H, Miyazaki Y, Okada F, Kanda Y, Kakeya H, Suzuki J, Kimura SI, Kishida M, Matsuda M, Niki Y. Efficacy and safety of isavuconazole against deep-seated mycoses: A phase 3, randomized, open-label study in Japan. J Infect Chemother. 2023 Feb;29(2):163-170. doi: 10.1016/j.jiac.2022.10.010. Epub 2022 Oct 25.
PubMed 36307059Shirae S, Ose A, Kumagai Y. Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Isavuconazonium Sulfate in Healthy Adult Japanese Subjects. Clin Pharmacol Drug Dev. 2022 Jun;11(6):744-753. doi: 10.1002/cpdd.1079. Epub 2022 Feb 21.
PubMed 35191210
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03471988
- Acronym / sponsor ID
- AK1820-301
- Conditions
- Deep Mycosis
- Keywords
- deep mycosis, aspergillosis, mucormycosis, cryptococcosis, isavuconazonium sulfate, isavuconazole, AK1820, Cresemba
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Asahi Kasei Therapeutics CorporationIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2018 (actual)
- Primary completion
- 21 Apr 2021 (actual)
- Study completion
- 21 Apr 2021 (actual)
- First posted
- 21 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AK1820 | Experimental | Drug: AK1820Participants 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. |
| Voriconazole | Active comparator | Drug: VoriconazoleParticipants 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK1820Only 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 | Drug | AK1820 |
| VoriconazoleOnly 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 | Drug | Voriconazole |
Primary outcome
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).
4 secondary outcomes
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.
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.
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.
All-cause mortality.
Time frame: Through 28 days after the last dose of study drug (up to approximately Day 112).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2021.
- Derived from this study: PubMed 36307059Kohno S, Izumikawa K, Takazono T, Miyazaki T, Yoshida M, Kamei K, Ogawa K, Taniguchi S, Akashi K, Tateda K, Mukae H, Miyazaki Y, Okada F, Kanda Y, Kakeya H, Suzuki J, Kimura SI, Kishida M, Matsuda M, Niki Y. Efficacy and safety of isavuconazole against deep-seated mycoses: A phase 3, randomized, open-label study in Japan. J Infect Chemother. 2023 Feb;29(2):163-170. doi: 10.1016/j.jiac.2022.10.010. Epub 2022 Oct 25.
- Derived from this study: PubMed 35191210Shirae S, Ose A, Kumagai Y. Pharmacokinetics, Safety, and Tolerability of Single and Multiple Doses of Isavuconazonium Sulfate in Healthy Adult Japanese Subjects. Clin Pharmacol Drug Dev. 2022 Jun;11(6):744-753. doi: 10.1002/cpdd.1079. Epub 2022 Feb 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AK1820 and Voriconazole in people with Deep Mycosis, run by Asahi Kasei Therapeutics Corporation at 33 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03471988, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2021.