Back to resultsA Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria
Primary Purpose
Malaria
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ferroquine (SSR97193)
amodiaquine
Sponsored by
About this trial
This is an interventional treatment trial for Malaria focused on measuring Malaria
Eligibility Criteria
Inclusion Criteria:
- Body weight between 50 kg and 90 kg with Body Mass Index >18 kg/m²
- Presence of body temperature ≥ 37.5°C or history of fever within the last 24 hours
- Monoinfection with Plasmodium falciparum and parasitemia within the 100 to 200,000/microL
Exclusion Criteria:
- Hypersensitivity to quinoleines or artesunate
- History or presence of any clinically significant disease or symptoms which, in the judgment of the investigator, might confuse the interpretation of the safety and efficacy information
- Splenectomized patients
- Laboratory parameters outside normal ranges
- Presence of HBs antigen, anti-HCV antibodies and anti-HIV 1&2 antibodies
- Cardio vascular and Electrocardiogram parameters outside normal values
- Presence of criteria of complicated malaria
- Permanent vomiting
- Previous treatment within 5 times the elimination half-life of any anti-malaria agents or with any marketed or investigational drugs (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever the longest, especially CYP3A and 2D6 main substrates
- Positive results on urine drug screen for anti-malaria agents (aminoquinolines)
- History of drug or alcohol abuse (alcohol consumption > 40 grams/day ; i. e. 2.5 beers of 33cl with 5 degrees of alcohol)
- Intention to use herbal medicine during the study period
- Immunization injection within last 15 days
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin
Secondary Outcome Measures
Parasite clearance assessed by repeated measurements of parasitemia
Pharmacokinetics of ferroquine assessed by repeated measurement of blood concentration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00563914
Brief Title
A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria
Official Title
An Open Label, 4 Escalating Dose, Randomized Multicentre Study Evaluating the Safety and Activity of Ferroquine Associated With Artesunate Versus a Positive Calibrator (Amodiaquine Associated With Artesunate) in African Adult Patients With Uncomplicated Malaria
Study Type
Interventional
2. Study Status
Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary objective is to assess the safety of different doses of ferroquine with artesunate (AS) in adult African patients with uncomplicated malaria.
The secondary objectives are to assess activity in reducing parasitemia and the pharmacokinetics of ferroquine and its metabolites.
Detailed Description
The study duration is 30 days including a 2 day screening period, a 3 day treatment period with a follow-up period of 25 days. Patients remain hospitalized 4 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malaria
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ferroquine (SSR97193)
Intervention Description
associated with artesunate
Intervention Type
Drug
Intervention Name(s)
amodiaquine
Intervention Description
associated with artesunate
Primary Outcome Measure Information:
Title
Hepatic safety :ALT, AST, Alkaline Phosphatase, Total Bilirubin
Time Frame
Sreening , baseline, days D3,D5,D6,D7,D9,D14,D21 and D28
Secondary Outcome Measure Information:
Title
Parasite clearance assessed by repeated measurements of parasitemia
Time Frame
Sreening, days D1(T6 and T12),D2 (T0 and T6), D3( T0, T6 and T12) ,D4,D7,D14,D21and D28
Title
Pharmacokinetics of ferroquine assessed by repeated measurement of blood concentration
Time Frame
up to 28 days after last dosing
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Body weight between 50 kg and 90 kg with Body Mass Index >18 kg/m²
Presence of body temperature ≥ 37.5°C or history of fever within the last 24 hours
Monoinfection with Plasmodium falciparum and parasitemia within the 100 to 200,000/microL
Exclusion Criteria:
Hypersensitivity to quinoleines or artesunate
History or presence of any clinically significant disease or symptoms which, in the judgment of the investigator, might confuse the interpretation of the safety and efficacy information
Splenectomized patients
Laboratory parameters outside normal ranges
Presence of HBs antigen, anti-HCV antibodies and anti-HIV 1&2 antibodies
Cardio vascular and Electrocardiogram parameters outside normal values
Presence of criteria of complicated malaria
Permanent vomiting
Previous treatment within 5 times the elimination half-life of any anti-malaria agents or with any marketed or investigational drugs (including St John's Wort) within 14 days before administration, or within 5 times the elimination half-life of that drug, whichever the longest, especially CYP3A and 2D6 main substrates
Positive results on urine drug screen for anti-malaria agents (aminoquinolines)
History of drug or alcohol abuse (alcohol consumption > 40 grams/day ; i. e. 2.5 beers of 33cl with 5 degrees of alcohol)
Intention to use herbal medicine during the study period
Immunization injection within last 15 days
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian Supan, MD
Organizational Affiliation
URM (Unité de Recherches Médicales), Hôpital Albert Schweitzer, BP 118 Lambaréné, Gabon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Lambaréné
Country
Gabon
Facility Name
Sanofi-Aventis Administrative Office
City
Nairobi
Country
Kenya
12. IPD Sharing Statement
Citations:
PubMed Identifier
28722611
Citation
Supan C, Mombo-Ngoma G, Kombila M, Ospina Salazar CL, Held J, Lell B, Cantalloube C, Djeriou E, Ogutu B, Waitumbi J, Otsula N, Apollo D, Polhemus ME, Kremsner PG, Walsh DS. Phase 2a, Open-Label, 4-Escalating-Dose, Randomized Multicenter Study Evaluating the Safety and Activity of Ferroquine (SSR97193) Plus Artesunate, versus Amodiaquine Plus Artesunate, in African Adult Men with Uncomplicated Plasmodium falciparum Malaria. Am J Trop Med Hyg. 2017 Aug;97(2):514-525. doi: 10.4269/ajtmh.16-0731. Epub 2017 Jul 19.
Results Reference
derived
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A Comparative Safety and Activity Study With Ferroquine Associated With Artesunate Versus Amodiaquine Associated With Artesunate in African Adult Patients With Uncomplicated Malaria
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