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

NCT02180165 | Completed Phase 3 Results

• 3 other identifiers: 5592-101142639MK-5592-101
• Study Type: interventional
• Target: 116
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With an Adverse Event

  An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol specified procedure, whether or not considered related to the medicinal product or protocol specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the Sponsor's product is also an AE.

  Up to approximately Day 98

Secondary Outcomes (19)

• Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42

  Day 42

• Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 84

  Day 84

• Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 42

  Day 42

• Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84

  Day 84

• Percentage of Participants With Successful Overall Response for Invasive Aspergillosis and Chronic Pulmonary Aspergillosis in Cohort 2 at End of Trial (Day 84)

  Day 84

Study Arms (4)

Cohort 1: Posaconazole

EXPERIMENTAL

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

Drug: Posaconazole

Cohort 1: Voriconazole

ACTIVE COMPARATOR

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

Drug: Voriconazole

Cohort 2: Posaconazole

EXPERIMENTAL

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

Drug: Posaconazole

Cohort 2: Voriconazole

ACTIVE COMPARATOR

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

Drug: Voriconazole

Interventions

Posaconazole 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: Posaconazole; Cohort 2: Posaconazole

Voriconazole 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 1: Voriconazole; Cohort 2: Voriconazole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• "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"

  RESULT

MeSH Terms

Conditions

Aspergillosis

Interventions

posaconazole; Voriconazole

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 2, 2014
• Study Start: July 29, 2014
• Primary Completion: January 24, 2018
• Study Completion: January 24, 2018
• Last Updated: January 28, 2021
• Results First Posted: January 11, 2019

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share