Safety and Efficacy of Pyronaridine Artesunate Vs Chloroquine in Children and Adult Patients With Acute Vivax Malaria
Study Details
Study Description
Brief Summary
The primary objective of this clinical study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (180:60 mg) with that of standard chloroquine therapy in children and adults with acute, uncomplicated Plasmodium vivax (P. vivax) malaria
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a multi-centre, randomised, double-blind, double-dummy, parallel group, comparative trial. It is a Phase III study designed to meet the regulatory requirements for registration of pyronaridine artesunate (PA) in Korea. Chloroquine will be used as a comparator, which is recognized as an effective and well-tolerated anti-malarial therapy, and is standard blood-stage therapy for patients with P. vivax malaria in Korea. This study will be conducted in a total of 40 male and female children (≥20 kg body weight) and adult patients suffering from acute symptomatic uncomplicated P. vivax malaria recruited from study sites in Korea.
Patients will be randomised in a 1:1 ratio to receive either oral PA (180:60-mg tablets) plus chloroquine-placebo or oral chloroquine (155 mg tablets) plus PA-placebo, once a day for 3 consecutive days (Days 0, 1, and 2). For PA, posology will be based on body weight ranges, with patients receiving 1 to 4 tablets per day depending on their body weight. The actual dose range covered by this regimen is 7.2:2.4 mg/kg to 13.8:4.6 mg/kg per day, which has been shown to be effective and safe in Phase I and II studies. The chloroquine daily dose is 10 mg/kg on Days 0 and 1 and 5 mg/kg on Day 2 for children and 620 mg on Days 0 and 1 and 310 mg on Day 2 for adults.
Patients will be confined to the study facility for ≥4 days (Days 0, 1, 2, and 3) and remain near the study site for ≥7 days, or once fever and parasite clearance has been confirmed for ≥24 hours - whichever occurs later.
The primary efficacy end point for the study is the crude cure rate on Day 14. Scheduled follow-up visits will continue until completion of the study at Day 42. In the case of adverse events reported and unresolved at Day 42, patients will be followed up for a further 30 days, or until resolution of the event.
It is anticipated that the study results will be pooled with the results of study SP-C-006-06 entitled "A Phase III Comparative (Double-blind, Double-dummy) Randomized Multicentre Study to Assess the Safety & Efficacy of Oral Pyronaridine Artesunate (180:60 mg) Versus Chloroquine (155 mg) in Children & Adult Patients with Acute Vivax Malaria " for a formal non-inferiority analysis.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Pyronaridine - artesunate Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. For patients who complete the study up to Day 28 and who have normal G-6-PD activity, a 14-day course of primaquine (15 mg/day) shall be administered starting on Day 28, after all required assessments have been performed, to complete their radical cure. Patients who are deficient in G-6-PD and who complete the study up to Day 28 will be treated as per country policy. |
Drug: Pyronaridine - artesunate
Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days.
Other Names:
|
| Active Comparator: Chloroquine Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days. For patients who complete the study up to Day 28 and who have normal G-6-PD activity, a 14-day course of primaquine (15 mg/day) shall be administered starting on Day 28, after all required assessments have been performed, to complete their radical cure. Patients who are deficient in G-6-PD and who complete the study up to Day 28 will be treated as per country policy. |
Drug: Chloroquine
Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days.
|
Outcome Measures
Primary Outcome Measures
- Crude Cure Rate on Day 14 [Day 14]
Percentage of subjects with crude cure rate at Day 14, defined as absence of parasitaemia on Day 14, irrespective of body temperature without previously meeting any of the criteria of treatment failure
Secondary Outcome Measures
- Crude Cure Rate on Day 28 [Day 28]
Percentage of subjects with crude cure rate at Day 28, defined as absence of parasitaemia on Day 28, irrespective of body temperature without previously meeting any of the criteria of treatment failure
- Parasite Clearance Time (PCT) [Days 0, 3, 7, 14, 21, 28, 35, and 42 (or on any other day if the subject spontaneously returned within the 42-day period)]
Parasite clearance time is defined as the time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance was defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart
- Fever Clearance Time (FCT) [Day 0 and every 8 hours over ≥72 hours following first study drug administration or temperature normalization for ≥2 readings between 7 and 25 hours apart, then at each visit (Days 7, 14, 28 and 42)]
Fever clearance time is defined as the time from first dosing to the first normal reading of temperature for 2 consecutive normal temperature readings taken between 7 and 25 hours apart
- Percentage of Patients Who Had Cleared Parasite on Days 1, 2, and 3 [Days 1, 2, and 3]
Parasite clearance is defined as at least 2 consecutive negative smears for asexual parasites obtained within an interval of 7 to 25 hours post-dosing
- Percentage of Patients Who Had Cleared Fever on Days 1, 2, and 3 [Days 1, 2, and 3]
Fever clearance is defined as at least 2 consecutive normal body temperature measurements (<37.5 C axillary/tympanic or <38.0 C oral/rectal) obtained within an interval of 7 to 25 hours postdosing
- Number of Participants With Adverse Events (AEs) [Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study]
Number of Participants with AEs, including clinically significant laboratory results, electrocardiogram (ECG), vital signs or physical examination abnormalities
Other Outcome Measures
- Crude Cure Rate on Day 42 [Day 42]
Proportion of subjects with crude cure rate at Day 42, defined as absence of parasitaemia on Day 42, irrespective of body temperature without previously meeting any of the criteria of treatment failure
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female patients between the age of 3 and 60 years, inclusive.
-
Body weight between 20 kg and 90 kg with no clinical evidence of severe malnutrition.
-
Presence of acute uncomplicated P. vivax mono-infection confirmed by:
-
Fever, as defined by axillary/tympanic temperature ≥37.5°C or oral/rectal temperature ≥38°C, or history of fever in the previous 24 hours (history of fever must be documented) and,
-
Positive microscopy of P. vivax with parasite density ≥250/ μL of blood (including at least 50% of asexual parasites).
-
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.
-
Ability to swallow oral medication.
-
Ability and willingness to participate based on information given to patient or parent or guardian and access to health facility.
Exclusion Criteria:
-
Presence of a mixed Plasmodium infection.
-
Presence of other clinical condition requiring hospitalization.
-
Presence of significant anaemia, as defined by Hb <8 g/dL.
-
Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, QTc interval greater than or equal to 450 msec), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including recent head trauma).
-
Known history of hypersensitivity, allergic or adverse reactions to pyronaridine, chloroquine or artesunate or other artemisinins.
-
Known history of hypersensitivity, allergic or adverse reactions to chloroquine, primaquine and related agents.
-
Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab).
-
Known seropositive HIV antibody.
-
Have received any antimalarial treatment in the preceding 2 weeks, as determined by history and, whenever feasible, by screening test.
-
Have received antibacterial with known antimalarial activity in the preceding 2 weeks.
-
Have received any investigational drug within the past 4 weeks.
-
Liver function tests (AST/ALT levels) >2.5 times the upper limit of normal range.
-
Known significant renal impairment as indicated by serum creatinine levels of >1.4 mg/dL.
-
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 to not become pregnant during the study period.
-
Previous participation in the present clinical trial with pyronaridine artesunate.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Inje University Ilsan Paik Hospital | Goyang-si | Korea, Republic of | 411-706 | |
| 2 | Eulji General Hospital | Seoul | Korea, Republic of | 139-711 |
Sponsors and Collaborators
- Medicines for Malaria Venture
- Shin Poong Pharmaceuticals
Investigators
- Study Director: Stephan Duparc, MD, Medicine for Malaria Venture
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SP-C-008-07
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Pyronaridine - Artesunate | Chloroquine |
|---|---|---|
| Arm/Group Description | Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. | Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days. |
| Period Title: Overall Study | ||
| STARTED | 15 | 15 |
| COMPLETED | 15 | 15 |
| NOT COMPLETED | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Pyronaridine - Artesunate | Chloroquine | Total |
|---|---|---|---|
| Arm/Group Description | Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. For patients who complete the study up to Day 28 and who have normal G-6-PD activity, a 14-day course of primaquine (15 mg/day) shall be administered starting on Day 28, after all required assessments have been performed, to complete their radical cure. Patients who are deficient in G-6-PD and who complete the study up to Day 28 will be treated as per country policy. Pyronaridine - artesunate: Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. | Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days. For patients who complete the study up to Day 28 and who have normal G-6-PD activity, a 14-day course of primaquine (15 mg/day) shall be administered starting on Day 28, after all required assessments have been performed, to complete their radical cure. Patients who are deficient in G-6-PD and who complete the study up to Day 28 will be treated as per country policy. Chloroquine: Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days. | Total of all reporting groups |
| Overall Participants | 15 | 15 | 30 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
38.2
(14.03)
|
42.3
(11.79)
|
40.3
(12.90)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
2
13.3%
|
4
26.7%
|
6
20%
|
| Male |
13
86.7%
|
11
73.3%
|
24
80%
|
| Race/Ethnicity, Customized (Count of Participants) | |||
| Asian/Oriental |
15
100%
|
15
100%
|
30
100%
|
Outcome Measures
| Title | Crude Cure Rate on Day 14 |
|---|---|
| Description | Percentage of subjects with crude cure rate at Day 14, defined as absence of parasitaemia on Day 14, irrespective of body temperature without previously meeting any of the criteria of treatment failure |
| Time Frame | Day 14 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations. |
| Arm/Group Title | Pyronaridine - Artesunate | Chloroquine |
|---|---|---|
| Arm/Group Description | Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. | Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days. |
| Measure Participants | 13 | 15 |
| Number (95% Confidence Interval) [percentage of participants] |
100
666.7%
|
100
666.7%
|
| Title | Crude Cure Rate on Day 28 |
|---|---|
| Description | Percentage of subjects with crude cure rate at Day 28, defined as absence of parasitaemia on Day 28, irrespective of body temperature without previously meeting any of the criteria of treatment failure |
| Time Frame | Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations. |
| Arm/Group Title | Pyronaridine - Artesunate | Chloroquine |
|---|---|---|
| Arm/Group Description | Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. | Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days. |
| Measure Participants | 13 | 15 |
| Number (95% Confidence Interval) [percentage of participants] |
100
666.7%
|
100
666.7%
|
| Title | Parasite Clearance Time (PCT) |
|---|---|
| Description | Parasite clearance time is defined as the time from first dosing to the time of first blood draw with parasite clearance. Parasite clearance was defined as zero presence of asexual parasites for 2 consecutive negative readings taken between 7 and 25 hours apart |
| Time Frame | Days 0, 3, 7, 14, 21, 28, 35, and 42 (or on any other day if the subject spontaneously returned within the 42-day period) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations. |
| Arm/Group Title | Pyronaridine - Artesunate | Chloroquine |
|---|---|---|
| Arm/Group Description | Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. | Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days. |
| Measure Participants | 13 | 15 |
| Median (95% Confidence Interval) [hours] |
32.0
|
63.9
|
| Title | Fever Clearance Time (FCT) |
|---|---|
| Description | Fever clearance time is defined as the time from first dosing to the first normal reading of temperature for 2 consecutive normal temperature readings taken between 7 and 25 hours apart |
| Time Frame | Day 0 and every 8 hours over ≥72 hours following first study drug administration or temperature normalization for ≥2 readings between 7 and 25 hours apart, then at each visit (Days 7, 14, 28 and 42) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations. |
| Arm/Group Title | Pyronaridine - Artesunate | Chloroquine |
|---|---|---|
| Arm/Group Description | Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. | Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days. |
| Measure Participants | 13 | 15 |
| Median (95% Confidence Interval) [hours] |
16.0
|
31.9
|
| Title | Percentage of Patients Who Had Cleared Parasite on Days 1, 2, and 3 |
|---|---|
| Description | Parasite clearance is defined as at least 2 consecutive negative smears for asexual parasites obtained within an interval of 7 to 25 hours post-dosing |
| Time Frame | Days 1, 2, and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations. |
| Arm/Group Title | Pyronaridine - Artesunate | Chloroquine |
|---|---|---|
| Arm/Group Description | Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. | Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days. |
| Measure Participants | 13 | 15 |
| Day 1 (24h after first dose) |
30.8
205.3%
|
0.0
0%
|
| Day 2 (48h after first dose) |
92.3
615.3%
|
26.7
178%
|
| Day 3 (72h after first dose) |
100.0
666.7%
|
60.0
400%
|
| Title | Percentage of Patients Who Had Cleared Fever on Days 1, 2, and 3 |
|---|---|
| Description | Fever clearance is defined as at least 2 consecutive normal body temperature measurements (<37.5 C axillary/tympanic or <38.0 C oral/rectal) obtained within an interval of 7 to 25 hours postdosing |
| Time Frame | Days 1, 2, and 3 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations. |
| Arm/Group Title | Pyronaridine - Artesunate | Chloroquine |
|---|---|---|
| Arm/Group Description | Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. | Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days. |
| Measure Participants | 13 | 15 |
| Clearance rate (%) at Day 1 (24h after first dose) |
76.9
512.7%
|
41.7
278%
|
| Clearance rate (%) at Day 2 (48h after first dose) |
92.3
615.3%
|
91.7
611.3%
|
| Clearance rate (%) at Day 3 (72h after first dose) |
100.0
666.7%
|
100.0
666.7%
|
| Title | Number of Participants With Adverse Events (AEs) |
|---|---|
| Description | Number of Participants with AEs, including clinically significant laboratory results, electrocardiogram (ECG), vital signs or physical examination abnormalities |
| Time Frame | Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population, consisting of all randomised subjects who received any amount of study medication; subjects were analysed as treated. |
| Arm/Group Title | Pyronaridine - Artesunate | Chloroquine |
|---|---|---|
| Arm/Group Description | Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. | Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days. |
| Measure Participants | 15 | 15 |
| Nr subj. with ≥1 AE |
10
66.7%
|
10
66.7%
|
| Nr subj. with ≥1 treatment-related AE |
7
46.7%
|
9
60%
|
| Nr subj. with ≥1 SAE |
0
0%
|
0
0%
|
| Nr subj. with ≥1 treatment-related SAE |
0
0%
|
0
0%
|
| Nr subj. with ≥1 severe or life-threatening AE |
0
0%
|
2
13.3%
|
| Nr subj. with ≥1 AE leading to death |
0
0%
|
0
0%
|
| Nr subj. with≥1 AE leading to drug discontinuation |
0
0%
|
0
0%
|
| Nr subj. with ≥1 AE leading to study withdrawal |
0
0%
|
0
0%
|
| Title | Crude Cure Rate on Day 42 |
|---|---|
| Description | Proportion of subjects with crude cure rate at Day 42, defined as absence of parasitaemia on Day 42, irrespective of body temperature without previously meeting any of the criteria of treatment failure |
| Time Frame | Day 42 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy evaluable population: completed a full course of study medication, did not miss a dose, did not use a concomitant medication that may have interfered with the treatment outcome up to D14, did not have a concomitant disease which may have interfered with the classification of the treatment outcome, did not have major protocol deviations. |
| Arm/Group Title | Pyronaridine - Artesunate | Chloroquine |
|---|---|---|
| Arm/Group Description | Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. | Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days. |
| Measure Participants | 13 | 15 |
| Number (95% Confidence Interval) [percentage of subjects] |
100
|
100
|
Adverse Events
| Time Frame | Day 0 to 42. Subjects experiencing AEs at Day 42 were followed for up to 30 days after the end of study | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Pyronaridine - Artesunate | Chloroquine | ||
| Arm/Group Description | Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days. | Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days. | ||
All Cause Mortality |
||||
| Pyronaridine - Artesunate | Chloroquine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 0/15 (0%) | ||
Serious Adverse Events |
||||
| Pyronaridine - Artesunate | Chloroquine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/15 (0%) | 0/15 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Pyronaridine - Artesunate | Chloroquine | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/15 (66.7%) | 10/15 (66.7%) | ||
| Blood and lymphatic system disorders | ||||
| Anemia | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Cardiac disorders | ||||
| Left ventricular hypertrophy | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal pain upper | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Diarrhoea | 1/15 (6.7%) | 1 | 1/15 (6.7%) | 1 |
| Dyspepsia | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Vomiting | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| General disorders | ||||
| Fatigue | 1/15 (6.7%) | 1 | 1/15 (6.7%) | 1 |
| Infections and infestations | ||||
| Hordeolum | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Nasopharyngitis | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Pharyngitis | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Investigations | ||||
| Alanine aminotransferase increased | 4/15 (26.7%) | 4 | 2/15 (13.3%) | 2 |
| Aspartate aminotransferase increased | 4/15 (26.7%) | 4 | 1/15 (6.7%) | 1 |
| Haemoglobin decreased | 2/15 (13.3%) | 2 | 3/15 (20%) | 3 |
| Haematocrit decreased | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Platelet count decreased | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Red blood cell count decreased | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| White blood cell count increased | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Blood alkaline phosphatase increased | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Electrocardiogram T wave inversion | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Transaminases increased | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Weight decreased | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Metabolism and nutrition disorders | ||||
| Anorexia | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Nervous system disorders | ||||
| Headache | 4/15 (26.7%) | 4 | 0/15 (0%) | 0 |
| Paraesthesia | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||
| Postnasal drip | 1/15 (6.7%) | 1 | 0/15 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||
| Urticaria | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
| Vascular disorders | ||||
| Hypotension | 0/15 (0%) | 0 | 1/15 (6.7%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Stephan Duparc, MD |
|---|---|
| Organization | Medicines for Malaria Venture |
| Phone | +41 22 555 0300 |
| duparcs@mmv.org |
- SP-C-008-07