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Phase 3 N=116 Randomized Treatment

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

Aspergillosis

Enrolled (actual)
116
Serious AEs
31.3%
Results posted
Jan 2019
Primary outcome: Primary: Number of Participants With an Adverse Event — 15; 6; 57; 27 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Posaconazole (Drug); Voriconazole (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Merck Sharp & Dohme LLC
Primary completion
Jan 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With an Adverse Event
15; 6; 57; 27
SECONDARY
Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42
40.0; 100
SECONDARY
Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 84
60.0; 100
SECONDARY
Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 42
56.3; 87.0
SECONDARY
Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84
58.3; 87.0
SECONDARY
Percentage of Participants With Successful Overall Response for Invasive Aspergillosis and Chronic Pulmonary Aspergillosis in Cohort 2 at End of Trial (Day 84)
58.5; 88.5
SECONDARY
Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 42
66.7
SECONDARY
Percentage of Participants With Successful Overall Response for Zygomycosis in Cohort 2 at Day 84
100
SECONDARY
Percentage of Participants With Successful Overall Response for Invasive Aspergillosis in Cohort 2 at Day 42 as Assessed by the Clinical Investigator
80.0; 66.7
SECONDARY
Percentage of Participants With Successful Overall Response for Chronic Pulmonary Aspergillosis in Cohort 2 at Day 84 as Assessed by the Clinical Investigator
60.4; 78.3
SECONDARY
Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 42
60.0; 0; 20.0; 66.7
SECONDARY
Percentage of Participants With Invasive Aspergillosis With Clinical Response of Resolution or Improvement in Cohort 2 at Day 84
60.0; 33.3; 20.0; 33.3
SECONDARY
Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 42
0; 0; 40.0; 100
SECONDARY
Percentage of Participants With Invasive Aspergillosis With Radiological Response of Resolution or Improvement in Cohort 2 at Day 84
0; 0; 60.0; 100
SECONDARY
Percentage of Participants With Invasive Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42
20.0; 0
SECONDARY
Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 42
43.8; 73.9
SECONDARY
Percentage of Participants With Chronic Pulmonary Aspergillosis With Clinical Response of Resolution in Cohort 2 at Day 84
45.8; 82.6
SECONDARY
Percentage of Participants With Chronic Pulmonary Aspergillosis With Radiological Response of Resolution in Cohort 2 at Day 42
58.3; 87.0
SECONDARY
Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 42
33.3; 21.7
SECONDARY
Percentage of Participants With Chronic Pulmonary Aspergillosis With Mycological Response of Eradication in Cohort 2 at Day 84
35.4; 21.7

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02180165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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