Clinical trial NCT02180165: Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)
Official title: A Randomized, Comparative, Open-label Study to Assess the Safety and Efficacy of MK-5592 Compared With Voriconazole in Japanese Subjects With Deep-seated Fungal Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Aspergillosis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2014-07-02
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Number of Participants With an Adverse Event
timeFrame: Up to approximately Day 98
Secondary outcomes:
measure: Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42
timeFrame: Day 42
measure: Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 84
timeFrame: Day 84
measure: Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 42
timeFrame: Day 42
measure: Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84
timeFrame: Day 84
measure: Percentage of Participants With Successful Overall Response for Invasive Aspergillosis and Chronic Pulmonary Aspergillosis in Cohort 2 at End of Trial (Day 84)
timeFrame: Day 84
measure: Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 42
timeFrame: Day 42
measure: Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 84
timeFrame: Day 84
measure: Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 as Assessed by the Clinical Investigator
timeFrame: Day 42
measure: Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84 as Assessed by the Clinical Investigator
timeFrame: Day 84
measure: Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 42
timeFrame: Day 42
measure: Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 84
timeFrame: Day 84
measure: Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 42
timeFrame: Day 42
measure: Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 84
timeFrame: Day 84
measure: Percentage of Participants With Invasive Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42
timeFrame: Day 42
measure: Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 42
timeFrame: Day 42
measure: Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 84
timeFrame: Day 84
measure: Percentage of Participants With Chronic Pulmonary Aspergillosis With Radiological Response of Resolution in Cohort 2 at Day 42
timeFrame: Day 42
measure: Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42
timeFrame: Day 42
measure: Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 84
timeFrame: Day 84
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: "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"