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Benznidazole

DRUG18 trials

Sponsors

Population Health Research Institute, Hospital de Niños R. Gutierrez de Buenos Aires, Hospital Universitari Vall d'Hebron Research Institute, Merck Sharp & Dohme LLC, Drugs for Neglected Diseases

Conditions

Chagas DiseaseChronic Chagas Disease, IndeterminateHeart DiseaseSafety IssuesTrypanosoma Cruzi InfectionTrypanosomiasis

Phase 1

Pharmacokinetic Drug-Drug Interaction Study
CompletedNCT03892213
Drugs for Neglected DiseasesChagas Disease
Start: 2014-10-31End: 2015-01-31Updated: 2019-03-27
A Phase 1 Study of the Safety and Tolerability of ICM20 in Adults
Active, not recruitingNCT05523596
IC-MedTech CorporationSafety Issues
Start: 2022-12-20End: 2027-03-31Updated: 2025-09-11

Phase 2

Clinical Trial For The Treatment Of Chronic Chagas Disease With Posaconazole And Benznidazole
CompletedNCT01162967
Hospital Universitari Vall d'Hebron Research InstituteChagas Disease
Start: 2010-09-30End: 2013-03-31Updated: 2013-09-10
A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)
CompletedNCT01377480
Merck Sharp & Dohme LLCChagas Disease
Start: 2011-07-06End: 2015-01-12Updated: 2018-08-27
Proof-of-Concept Study of E1224 to Treat Adult Patients With Chagas Disease
NCT01489228
Drugs for Neglected DiseasesChronic Chagas Disease, Indeterminate
Start: 2011-06-30End: 2013-12-31Target: 230Updated: 2011-12-21
CHICAMOCHA 3 - Equivalence of Usual Interventions for Trypanosomiasis (EQUITY)
NCT02369978
Universidad Autónoma de BucaramangaChagas Disease
Start: 2015-08-31End: 2019-02-28Target: 500Updated: 2017-07-21
Evaluation of Different Benznidazole Regimens for the Treatment of Chronic Chagas Disease.
CompletedNCT03191162
Hospital Universitari Vall d'Hebron Research InstituteChagas Disease, Trypanosoma Cruzi Infection
Start: 2017-04-21End: 2021-03-16Updated: 2023-12-19
BENDITA BEnznidazole New Doses Improved Treatment and Associations
NCT03378661
Drugs for Neglected DiseasesChagas Disease
Start: 2016-11-30End: 2018-07-27Updated: 2017-12-20
New Therapies and Biomarkers for Chagas Infection
CompletedNCT03981523
University of Texas, El PasoChagas Disease, Trypanosoma Cruzi Infection
Start: 2019-12-18End: 2024-05-31Updated: 2024-07-17
A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
RecruitingNCT06632600
Novartis PharmaceuticalsChagas Disease
Start: 2025-04-28End: 2030-09-21Target: 130Updated: 2026-03-30

Phase 3

BENEFIT: Evaluation of the Use of Antiparasital Drug (Benznidazole) in the Treatment of Chronic Chagas' Disease
CompletedNCT00123916
Population Health Research InstituteChagas Disease, Heart Disease, Trypanosomiasis
Start: 2004-11-30End: 2015-08-31Updated: 2020-03-03
Etiologic Treatment With Benznidazole in Adult Patients With Chronic Chagas Disease. A Randomized Clinical Trial
CompletedNCT02386358
Instituto Nacional de Parasitologia Dr. Mario Fatala ChabenChagas Disease
Start: 1999-03-31End: 2013-04-30Updated: 2015-03-11
Short-course Benznidazole Treatment to Reduce Trypanosoma Cruzi Parasitic Load in Women of Reproductive Age
Active, not recruitingNCT03672487
Tulane University School of Public Health and Tropical MedicineChagas Disease
Start: 2019-06-01End: 2025-05-31Updated: 2025-05-21
Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease
Active, not recruitingNCT04024163
Insud PharmaChagas Disease
Start: 2019-09-19End: 2028-03-30Updated: 2023-08-14

Phase 4

Optimization of PCR Technique to Assess Parasitological Response for Patients With Chronic Chagas Disease
CompletedNCT01678599
Drugs for Neglected DiseasesChagas Disease
Start: 2011-04-30End: 2013-04-30Updated: 2018-06-25
Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease
CompletedNCT01755403
Barcelona Centre for International Health ResearchChagas Disease
Start: 2012-12-31End: 2013-11-30Updated: 2015-05-27

Unknown Phase

Population Pharmacokinetics of Benznidazole in Children With Chagas Disease
CompletedNCT00699387
Hospital de Niños R. Gutierrez de Buenos AiresChagas Disease
Start: 2007-04-30End: 2011-05-31Updated: 2011-08-01
New Tools for the Diagnosis, Prognosis and Treatment Follow-up in Chagas Disease
CompletedNCT01755377
Barcelona Centre for International Health ResearchChagas Disease
Start: 2012-12-31End: 2016-06-30Updated: 2016-08-22

Related Papers

Population pharmacokinetic-pharmacodynamic analysis of benznidazole monotherapy and combination therapy with fosravuconazole in chronic Chagas disease (BENDITA)
PLoS neglected tropical diseases2025-09-22
Simulated pharmacokinetic profiles, by sex.
OPAL (Open@LaTrobe) (La Trobe University)2025-09-22
Number of follow-up visits.
OPAL (Open@LaTrobe) (La Trobe University)2025-09-22
Secondary pharmacokinetic parameter estimates.
OPAL (Open@LaTrobe) (La Trobe University)2025-09-22
Outlier analysis.
OPAL (Open@LaTrobe) (La Trobe University)2025-09-22
Flow chart of excluded patients.
OPAL (Open@LaTrobe) (La Trobe University)2025-09-22
Quantifying anti-trypanosomal treatment effects in chronic indeterminate Chagas disease: a secondary analysis of individual patient data from two proof-of-concept trials.
2025-09-093 citations
Cutaneous reactions during treatment with Nifurtimox or Benznidazole among <i>Trypanosoma cruzi</i> seropositive adults without symptomatic cardiomyopathy: A safety sub analysis of a placebo‐controlled randomised trial
Tropical Medicine & International Health2025-05-192 citations
Early assessment of antibodies decline in Chagas patients following treatment using a serological multiplex immunoassay.
2024-12-032 citations
Efficacy of three benznidazole dosing strategies for adults living with chronic Chagas disease (MULTIBENZ): an international, randomised, double-blind, phase 2b trial.
2024-01-1131 citations
Population pharmacokinetics of benznidazole in neonates, infants and children using a new pediatric formulation
PLoS neglected tropical diseases2023-05-3110 citations
Human Trypanosoma cruzi chronic infection leads to individual level steady-state parasitemia: Implications for drug-trial optimization in Chagas disease
PLoS neglected tropical diseases2022-11-2111 citations
New chemotherapy regimens and biomarkers for Chagas disease: the rationale and design of the TESEO study, an open-label, randomised, prospective, phase-2 clinical trial in the Plurinational State of Bolivia
BMJ Open2021-12-0136 citations
New regimens of benznidazole monotherapy and in combination with fosravuconazole for treatment of Chagas disease (BENDITA): a phase 2, double-blind, randomised trial.
2021-04-06129 citations
Short-course Benznidazole treatment to reduce Trypanosoma cruzi parasitic load in women of reproductive age (BETTY): a non-inferiority randomized controlled trial study protocol.
2020-08-2427 citations
Efficacy and safety assessment of different dosage of benznidazol for the treatment of Chagas disease in chronic phase in adults (MULTIBENZ study): study protocol for a multicenter randomized Phase II non-inferiority clinical trial.
2020-04-1544 citations
Nifurtimox versus benznidazole or placebo for asymptomatic Trypanosoma cruzi infection (Equivalence of Usual Interventions for Trypanosomiasis - EQUITY): study protocol for a randomised controlled trial
Trials2019-07-1533 citations
Usefulness of Serial Blood Sampling and PCR Replicates for Treatment Monitoring of Patients with Chronic Chagas Disease
Antimicrobial Agents and Chemotherapy2018-12-0449 citations
What to expect and when: benznidazole toxicity in chronic Chagas' disease treatment.
2018-04-0160 citations
Treatment of adult chronic indeterminate Chagas disease with benznidazole and three E1224 dosing regimens: a proof-of-concept, randomised, placebo-controlled trial.
2018-01-16198 citations

6 more papers not shown