Phase 2
N=477
Phase II Dose-ranging Study of Pyronaridine/Artesunate in Adults Patients With Plasmodium Falciparum Malaria
Plasmodium Falciparum Malaria
Bottom Line
View on ClinicalTrials.gov: NCT01594931 ↗Enrolled (actual)
477
Serious AEs
0.8%
Results posted
Sep 2021
Primary outcome: Primary: PCR-Corrected ACPR at Day 28 — 95; 99; 99 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- pyronaridine/artesunate (Drug)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Medicines for Malaria Venture
- Primary completion
- Mar 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PCR-Corrected ACPR at Day 28 |
95; 99; 99 | — |
| SECONDARY PCR-Corrected ACPR at Day 14 |
100; 100; 100 | — |
| SECONDARY Parasite Clearance Time |
36.9; 33.6; 30.8 | — |
| SECONDARY Fever Clearance Time |
16.8; 24.0; 17.0 | — |
| SECONDARY Parasite Clearance |
74; 82; 84; 93; 96; 95 | — |
| SECONDARY Fever Clearance |
96; 91; 96; 99; 96; 100 | — |
| SECONDARY Adverse Events (AEs) |
106; 90; 91; 35; 33; 36 | — |
Summary
The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P. falciparum malaria in South East Asia and Africa. Secondary trial objectives are to determine the safety of once-daily dosing for 3 days of PA and to explore possible ethnic differences in safety or efficacy.
Eligibility Criteria
Inclusion Criteria
- Male or female patients between the age of 15 and 60 years of age inclusive
- Written informed consent, in accordance with local practice, provided by patient and/or parent/guardian/spouse. If the patient is unable to write, witnessed consent is permitted according to local ethical considerations
- Absence of severe malnutrition (defined as the weight-for-height being below -3 standard deviations or 3 times in the 24 hours prior to inclusion in the trial or inability to tolerate oral treatment
- Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other clinically important abnormality (including head trauma).
- Presence of febrile conditions caused by diseases other than malaria
- Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins
- Evidence of use of any other antimalarial agent within 2 weeks prior to the start of the study confirmed by a negative urine test or using Eggelte dipsticks
- Positive urine pregnancy test or lactating
- Received an investigational drug within the past 4 weeks
- Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab)
- Known seropositive HIV antibody
- Liver function tests [ASAT/ALAT levels] >2.5 times upper limit of normal values
- Known significant renal impairment as indicated by a serum creatinine of ≥ 1.4 mg/dl
- Previous participation in this clinical trial
Data sourced from ClinicalTrials.gov (NCT01594931). 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.