Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01445938
• Date of registration: 26/09/2011
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Anti-parasitic Activity and Safety Assessment of SAR97276A in Children With Uncomplicated Malaria
• Scientific title: An Open-label, Randomized Multicenter Study to Investigate the Anti-parasitic Activity, Pharmacokinetic and Safety of IM SAR97276A With Oral ACTs as Positive Control in Children Presenting With Symptomatic Plasmodium Falciparum Uncomplicated Malaria
• Date of first enrolment: October 2011
• Target sample size: 20
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01445938
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Benin, Burkina Faso, Gabon, Kenya

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion criteria:

- Patients diagnosed with symptomatic infection by Plasmodium falciparum
microscopically confirmed in blood smear at Day-1 visit

- Fever (tympanic or rectal temperature = 38 C) or documented history of fever within
the last 24h

- Asexual parasitemia of = 2 000 parasites/µL in blood smear at D-1 visit

- Signed Informed Consent Form by the parents or legal guardian

- Age: 12 to 17 years old for step 1

- Age: 2 to 11 years old for step 2 and step 3

Exclusion criteria:

- Participation in another clinical trial within the last 3 months or participation
within a different cohort in this PDY11737 clinical trial or participation to
previous trial with SAR97276

- Documented history of adequate treatment with antimalarials expected to be effective
within the preceding 72 hours

- Severe concomitant disease (including concomitant febrile illnesses or infection)

- Any sign suggestive of severe malaria

- Severe malnutrition

- Asexual parasitemia: Plasmodium falciparum > 100,000 parasites/µL in blood smear at
D-1 visit

- Previous treatment within 3 weeks prior to inclusion, and concomitant treatment with
potent CYP3A4 inhibitors or CYP3A4 inducers or CYP2D6 substrates or potent CYP2D6
inhibitors

- Known serious adverse event reaction or hypersensitivity to Artemisinin-Based
Combination Therapy (ACTs) or any contraindications from the positive control therapy
(Artemisinin Combined Treatments) or warning/precaution of use as defined in the
respective National Product Labeling

- Pregnant or breast-feeding women

- Women of childbearing potential not protected by effective contraceptive method of
birth control, or not willing to use an effective contraceptive(s) method(s) for the
duration of the study (e.g.: double barrier method), and/or who are unwilling or
unable to be tested for pregnancy,

- CPK above 3 ULN,

- Underlying hepatobiliary disease or ALT>3 ULN.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.



Age minimum: 2 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Drug: SAR97276A

Drug: arthemeter + lumefantrine (ACTs)

Primary Outcome(s)

Parasite Reduction Ratio (PRR) [Time Frame: at 72 hours]

Secondary Outcome(s)

Evolution of mean Gametocytes count over time (nb/µL) [Time Frame: from baseline to end of study (day 28 ± 2)]

SAR97276 pharmacokinetic profile in plasma and blood [Time Frame: from baseline up to 12 hours after the last study drug intake on (Day 3]

Fever Clearance (time to reach Temperature < 38°C) [Time Frame: every 6 hours from baseline up to 72 hours (day 4)]

General conditions improvement: mean total symptom score over time [Time Frame: every 6 hours from baseline up to 72 hours (day 4)]

Evolution of mean Parasitaemia over time (nb/µL) [Time Frame: every 6 hours from baseline up to 72 hours (day 4)]

Secondary ID(s)

2010-021398-36

PDY11737

U1111-1118-0694

Source(s) of Monetary Support

Please refer to primary and secondary sponsors