Phase 3
N=448
Phase II Efficacy Study of Artefenomel & Piperaquine in Adults & Children With P. Falciparum Malaria.
Uncomplicated Plasmodium Falciparum Malaria
Bottom Line
View on ClinicalTrials.gov: NCT02083380 ↗Enrolled (actual)
448
Serious AEs
0.9%
Results posted
Jan 2017
Primary outcome: Primary: PCR-adjusted ACPR at Day 28 in the PP Population (All Patients) — 70.8; 68.4; 78.6 % ACPR PCR-adjusted
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Artefenomel 800mg: piperaquine 640mg (Drug); Artefenomel 800mg: piperaquine 960mg (Drug); Artefenomel 800mg: piperaquine 1440mg (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Medicines for Malaria Venture
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PCR-adjusted ACPR at Day 28 in the PP Population (All Patients) |
70.8; 68.4; 78.6 | — |
| PRIMARY PCR-adjusted ACPR at Day 28 in the PP Population: Asia (All Ages) |
64; 64; 70.4 | — |
| PRIMARY PCR-adjusted ACPR at Day 28 in the PP Population: Africa (All Ages) |
72.8; 69.6; 81.1 | — |
| PRIMARY PCR-adjusted ACPR at Day 28 in the PP Population: Africa (> Than 5 Years) |
77.8; 90.5; 89.5 | — |
| PRIMARY PCR-adjusted ACPR at Day 28 in the PP Population: Africa (< = 5 Years) |
71.4; 63.4; 78.9 | — |
| PRIMARY PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>2 to <= 5 Years) |
75.6; 74.0; 83.6 | — |
| PRIMARY PCR-adjusted ACPR at Day 28 in the PP Population: Africa (>= 0.5 to <= 2 Years) |
61.1; 38.1; 62.5 | — |
| SECONDARY PCR - Adjusted ACPR at Day 42 in the PP Population |
65.0; 65.7; 72.0 | — |
| SECONDARY PCR-adjusted ACPR at Day 63 in the PP Population |
57.8; 58.9; 69.0 | — |
| SECONDARY Crude ACPR at Day 28 in the PP Population |
57.4; 56.6; 66.9 | — |
| SECONDARY Crude ACPR at Day 42 in the PP Population |
48.0; 48.5; 51.5 | — |
| SECONDARY Crude ACPR at Day 63 in the PP Population |
42.1; 39.3; 49.1 | — |
| SECONDARY PCR-adjusted ACPR at Day 28 in the ITT Population |
53.8; 55.4; 65.1 | — |
| SECONDARY PCR-adjusted ACPR at Day 42 in the ITT Population |
46.9; 48.6; 50.0 | — |
| SECONDARY PCR-adjusted ACPR at Day 63 in the ITT Population |
36.8; 38.6; 43.7 | — |
| SECONDARY Crude ACPR at Day 28 in the ITT Population |
53.1; 53.4; 63.0 | — |
| SECONDARY Crude ACPR at Day 42 in the ITT Population |
44.1; 44.6; 46.6 | — |
| SECONDARY Crude ACPR at Day 63 in the ITT Population |
36.8; 35.0; 43.0 | — |
| SECONDARY Kaplan-Meier Estimate of Recurrence |
44.7; 54.6; 43.6 | — |
| SECONDARY Kaplan-Meier Estimate of Recrudescence |
22.7; 29.1; 18.6 | — |
| SECONDARY Kaplan-Meier Estimate of New Infection Rate |
11.3; 16.3; 13.6 | — |
| SECONDARY Parasite Clearance Time |
36.1; 36.0; 36.1 | — |
| SECONDARY Fever Clearance Time |
1.0; 1.2; 1.1 | — |
| SECONDARY PRR48 |
9.120; 9.300; 8.690 | — |
Summary
A randomised, double-blind single-dose study to determine the efficacy, safety, tolerability and pharmacokinetics of OZ439 (artefenomel) in combination with piperaquine (PQP) in patients > 0.5 years and <= 70 years of age with uncomplicated Plasmodium falciparum malaria in Africa and Asia (Vietnam).
Interim analyses for futility were planned. Adults and children will be included through progressive step-down in age following safety review by an independent safety monitoring board (ISMB).
If the study were to meets its efficacy objectives, this will inform dose setting for Phase III studies.
Eligibility Criteria
Inclusion Criteria
- Male or female patient age >6 months 5 kg 1 and ≤ 1.5xULN, exclude the patient if AST/ALT >1.5xULN.
- Total Bilirubin > 1.5XULN
- Haemoglobin level below 8 g/dL.
- Serum creatinine levels ≥2 x ULN
- Female patients of child bearing potential must be neither pregnant (as demonstrated by a negative pregnancy test) nor lactating, and must be willing to take measures not to become pregnant during the study period and safety follow-up period.
- Have received an investigational drug within the past 4 weeks.
- Previous participation in any malaria vaccine study or received malaria vaccine in any other circumstance.
Data sourced from ClinicalTrials.gov (NCT02083380). 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.