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Trial record 37 of 48 for:    ( Map: Gabon )

To Evaluate the Efficacy of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria (FALCI)

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ClinicalTrials.gov Identifier: NCT02497612
Recruitment Status : Terminated (All treatment arms met the futility criteria for efficacy during the pre-planned interim analysis, therefore the study was stopped.)
First Posted : July 14, 2015
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi

Brief Summary:

Primary Objective:

To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) is an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children.

Secondary Objectives:

- To evaluate the efficacy of OZ439 (Artefenomel)/FQ (Ferroquine): .To determine the incidence of recrudescence and re-infection. .To determine the time to relief of fever and parasite clearance.

  • To evaluate the safety and tolerability of OZ439 (Artefenomel)/FQ (Ferroquine).
  • To evaluate the pharmacokinetics of OZ439 (Artefenomel)/FQ (Ferroquine).
  • To explore in vitro drug resistance of P. falciparum infecting patients >14 years old in Vietnamese sites.

Condition or disease Intervention/treatment Phase
Plasmodium Falciparum Infection Drug: Ferroquine SSR97193 Drug: Artefenomel Other: Placebo Phase 2

Detailed Description:
Total duration will be up to 67 days for each patient.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 377 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Phase IIb Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine (FQ) With Artefenomel (OZ439) in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
Actual Study Start Date : July 25, 2015
Actual Primary Completion Date : September 23, 2019
Actual Study Completion Date : September 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Experimental: Ferroquine Dose 1 + Artefenomel

Ferroquine Dose 1 single dose + artefenomel fixed single dose, oral take, for patients >14 years old & body weight ≥35 kg.

Ferroquine weight-adjusted single dose + artefenomel weight adjusted dose, oral take, for patients <35 kg.

Drug: Ferroquine SSR97193
Pharmaceutical form:Capsules Route of administration: oral

Drug: Artefenomel
Pharmaceutical form:Granules for suspension Route of administration: oral

Other: Placebo
Capsules Placebo capsules are used to keep the same number of capsules in each weight band while keeping the ferroquine dose blinded. No patient will receive placebo only.

Experimental: Ferroquine Dose 2 + Artefenomel

Ferroquine Dose 2 single dose + artefenomel fixed single dose, oral take, for patients >14 years old & body weight ≥35 kg.

Ferroquine weight-adjusted single dose + artefenomel weight adjusted dose, oral take, for patients <35 kg.

Drug: Ferroquine SSR97193
Pharmaceutical form:Capsules Route of administration: oral

Drug: Artefenomel
Pharmaceutical form:Granules for suspension Route of administration: oral

Other: Placebo
Capsules Placebo capsules are used to keep the same number of capsules in each weight band while keeping the ferroquine dose blinded. No patient will receive placebo only.

Experimental: Ferroquine Dose 3 + Artefenomel

Ferroquine Dose 3 single dose + artefenomel fixed single dose, oral take, for patients >14 years old & body weight ≥35 kg.

Ferroquine weight-adjusted single dose + artefenomel weight adjusted dose, oral take, for patients <35 kg.

Drug: Ferroquine SSR97193
Pharmaceutical form:Capsules Route of administration: oral

Drug: Artefenomel
Pharmaceutical form:Granules for suspension Route of administration: oral

Other: Placebo
Capsules Placebo capsules are used to keep the same number of capsules in each weight band while keeping the ferroquine dose blinded. No patient will receive placebo only.

Experimental: Ferroquine Dose 4 + Artefenomel

Ferroquine Dose 4 single dose + artefenomel fixed single dose, oral take, for patients >14 years old & body weight ≥35 kg.

Ferroquine weight-adjusted single dose + artefenomel weight adjusted dose, oral take, for patients <35 kg.

Drug: Ferroquine SSR97193
Pharmaceutical form:Capsules Route of administration: oral

Drug: Artefenomel
Pharmaceutical form:Granules for suspension Route of administration: oral

Other: Placebo
Capsules Placebo capsules are used to keep the same number of capsules in each weight band while keeping the ferroquine dose blinded. No patient will receive placebo only.




Primary Outcome Measures :
  1. Percentage of patients with Polymerase Reaction Chain (PCR)-adjusted Adequate Clinical and Parasitological Response (ACPR) [ Time Frame: Day 28 ]

Secondary Outcome Measures :
  1. Percentage of patients with PCR - adjusted ACPR [ Time Frame: Day 42 and Day 63 ]
  2. Percentage of patients with PCR - crude ACPR [ Time Frame: Day 28, Day 42, and Day 63 ]
  3. Time to re-emergence [ Time Frame: Up to Day 63 ]
  4. Time to recrudescence [ Time Frame: Up to Day 63 ]
  5. Parasite clearance time [ Time Frame: Up to Day 63 ]
  6. Number of patients with adverse events, including Serious Adverse Events (SAE), Adverse Event of Special Interest (AESI) and Treatment Emergent Adverse Event (TEAE) [ Time Frame: Up to Day 63 or event resolution ]
  7. Time to reinfection [ Time Frame: Up to Day 63 ]
  8. Fever Clearance Time [ Time Frame: Up to Day 63 ]
  9. Parasite Reduction Rate [ Time Frame: Up to Day 63 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Months to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

Male or female patient aged >6 months old and <70 years old:

  • Cohort 1 = 14 years < age <70 years and body weight ≥35 kg.
  • Cohort 2 = 5 years < age ≤14 years.
  • Cohort 3 = 2 years < age ≤5 years.
  • Cohort 4 = 6 months < age ≤2 years. Body weight ≥5 kg and ≤90 kg.

Presence of mono-infection by P. falciparum with:

  • Fever, as defined by axillary temperature ≥37.5 C or oral/rectal/tympanic temperature ≥38 C, or history of fever in the previous 24 hours (history of fever must be documented) and,
  • Microscopically (blood smear) confirmed parasite infection, ranging from 1000 to 100 000 asexual parasites/µL of blood.

Informed Consent Form signed by the patient or by the legally acceptable representative of the minor patient.

Exclusion criteria:

Presence of severe malaria.

Anti-malarial treatment:

  • With piperaquine -based compound, mefloquine, naphthoquine or sulphadoxine/pyrimethamine (SP) within the previous 6 weeks (after their inhibition of new infections has fallen below 50%).
  • With amodiaquine or chloroquine within the previous 4 weeks.
  • With quinine, halofantrine, lumefantrine-based compounds and any other anti-malarial treatment or antibiotics with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones, and azithromycin) within the past 14 days.
  • With any herbal products or traditional medicines, within the past 7 days. Known history or evidence of clinically significant disorders. Previous treatment within 5 times the half-life or within the last 14 days, whichever the longest which are: P-gp substrates, CYP2D6 main substrates and/or strong CYP2C or CYP3A inhibitors and/or moderate inhibitors but inhibiting both CYP2C and CYP3A and/or CYP inducers.

Mixed plasmodium infection. Severe vomiting. Severe malnutrition. Laboratory parameters with clinical significant abnormalities and/or reaching critical values. For Liver Function Test. Aspartate transferase [AST >2 ULN], or alanine transferase [ALT >2 ULN] or total bilirubin >1.5 ULN.

Presence of Hepatitis A Immunoglobulin M (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab).

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.

Measles and yellow fever vaccine injection within the last 15 days and or planned for the 28 days after randomization.

Female patient of child bearing potential not willing to use an effective contraceptive(s) method(s) for the duration of the study.

Positive serum or urine beta-human chorionic gonadotropin (ß-HCG) pregnancy at study screening for female participants of childbearing potential.

Breastfeeding women. Male patient having a partner of child bearing potential not willing to use an effective method of birth control during the study treatment period.

Splenectomized patients or presence of surgical scar on left hypochondrium. Patient unable to drink. Known history of hypersensitivity, allergic or anaphylactoid reactions to ferroquine or other amino-quinolines or to OZ439 or OZ277 or to any of the excipients.

Family history of sudden death or of congenital prolongation of the QTc interval or known congenital prolongation of the QTc-interval or any clinical condition known to prolong the QTc interval e.g., patients with a history of symptomatic cardiac arrhythmias or with clinically relevant bradycardia.

QTcF >450 ms at screening. Hypokalemia (<3.5 mmol/L), hypocalcemia (<2.0 mmol/L) or hypomagnesemia (<0.5 mmol/L) at screening Any treatment known to induce a lengthening of QT interval.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497612


Locations
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Benin
Investigational Site Number 204001
Cotonou, Benin
Burkina Faso
Investigational Site Number 854001
Nanoro, Burkina Faso
Investigational Site Number 854003
Niangoloko, Burkina Faso, 0000
Investigational Site Number 854002
Ouagadougou, Burkina Faso
Gabon
Investigational Site Number 266001
Dalian, Gabon
Investigational Site Number 266002
Lambaréné, Gabon
Kenya
Investigational Site Number 404002
Kisian, Kenya
Investigational Site Number 404003
Kisumu, Kenya, 40100
Mozambique
Investigational Site Number 508001
Chengdu, Mozambique
Uganda
Investigational Site Number 800002
Tororo, Uganda, 0000
Vietnam
Investigational Site Number 704003
Binh Phuoc, Vietnam, 0000
Investigational Site Number 704004
Gia Lai, Vietnam, 54000
Investigational Site Number 704001
Khanh Hoa, Vietnam, 0000
Investigational Site Number 704002
Quang Tri, Vietnam, 0000
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT02497612     History of Changes
Other Study ID Numbers: DRI12805
U1111-1155-7960 ( Other Identifier: UTN )
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Ferroquine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents