Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)

NCT ID: NCT02180165

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-29
• Study Completion Date: 2018-01-24

Brief Summary

The primary objective of this study is to assess and compare the safety of posaconazole with voriconazole in Japanese participants with aspergillosis.

Conditions

Aspergillosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1: Posaconazole

300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days

Group Type: EXPERIMENTAL

Posaconazole

Intervention Type: DRUG

300 mg posaconazole twice on Day 1, either by oral tablet or IV solution; followed by 300 mg once daily for up to 84 days

Cohort 1: Voriconazole

300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days

Group Type: ACTIVE_COMPARATOR

Voriconazole

Intervention Type: DRUG

300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days

Cohort 2: Posaconazole

300 mg posaconazole oral tablet (or 300 mg intravenous (IV) solution) twice on Day 1, followed by 300 mg oral tablet or IV solution once daily for up to 84 days

Group Type: EXPERIMENTAL

Posaconazole

Intervention Type: DRUG

300 mg posaconazole twice on Day 1, either by oral tablet or IV solution; followed by 300 mg once daily for up to 84 days

Cohort 2: Voriconazole

300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days

Group Type: ACTIVE_COMPARATOR

Voriconazole

Intervention Type: DRUG

300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days

Interventions

Posaconazole

300 mg posaconazole twice on Day 1, either by oral tablet or IV solution; followed by 300 mg once daily for up to 84 days

Intervention Type: DRUG

Voriconazole

300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body weight >=45 kg
• Can be treated by taking tablet orally or intravenous (IV) formulation via central vein
• Female has a negative pregnancy test
• Female of non-childbearing potential; or if of childbearing potential, agrees to use proper combination of barrier method of birth control
• Met screening criteria for either Invasive aspergillosis, chronic pulmonary aspergillosis, zygomycosis or fusariosis.

Exclusion Criteria

• Has a fungal infection other than Aspergillus any species (spp.) Zygomycetes (including Mucor spp.) and Fusarium spp. infection
• Has allergic bronchopulmonary aspergillosis, allergic sinusitis of aspergillosis, or aspergillosis of the eye
• Has long-term inactive aspergilloma not expected to respond to investigational product
• Is not expected to survive study duration
• Has an underlying disease, complication and systemic condition which makes it difficult to evaluate effect of study drug
• Has received, or continues to receive any systemic antifungal therapy, and cannot discontinue this treatment; but if fungal infection does not improve, can switch to study drug
• Is expected to need prohibited medications
• Has received posaconazole, has received voriconazole for this infection in the past and has deep-seated fungal infection that has not responded to this treatment, has intolerance for azole antifungal treatments, or is receiving antifungal combination therapy for chronic pulmonary aspergillosis
• Has known hypersensitivity to any medication
• Has history of either Torsade de Pointes, myocardial infarction within previous 90 days, has congenital or acquired long QT interval syndrome, or unstable cardiac arrhythmia
• Has significant liver dysfunction
• Has liver cirrhosis or cholestasis
• Has renal insufficiency
• Has a known hereditary problem of either galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• Has acute symptomatic pancreatitis within 6 months of study entry or chronic pancreatitis
• Has an active skin lesion consistent with squamous cell carcinoma or melanoma, or within prior 5 years a history of malignant melanoma
• Has known or suspected Gilbert's disease
• Female is pregnant, or nursing, or intends to become pregnant within 14 days after end of study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

"Kohno S, Izumikawa K, Yoshida M, Okada F, Mori T, Najima Y, Waskin H, Shizuya T, Fukuhara T, Adachi N, Niki Y. A Randomized, Active-controlled, Open-label, Comparative Study to Assess the Safety and Efficacy of Posaconazole in Japanese Subjects with Deep-seated Fungal Infection. Nihon Ishinkin Gakkai Zasshi. 2020; 61(1):1-11. PDF file: https://www.jstage.jst.go.jp/article/ishinkin/61/1/61_19-00015/_pdf/-char/ja Web page: https://www.jstage.jst.go.jp/article/ishinkin/61/1/61_19-00015/_article/-char/ja"

Reference Type: RESULT

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

142639

Identifier Type: REGISTRY

Identifier Source: secondary_id

MK-5592-101

Identifier Type: OTHER

Identifier Source: secondary_id

5592-101

Identifier Type: -

Identifier Source: org_study_id