Phase 3
N=116
Assessing the Safety and Efficacy of MK-5592 (Posaconazole) in Japanese Participants With Fungal Infection (MK-5592-101)
Aspergillosis
Bottom Line
View on ClinicalTrials.gov: NCT02180165 ↗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
| Outcome | Result | p-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.
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.