A Phase 2/3 interventional study of Nifurtimox and Benznidazole in Chagas Disease, sponsored by Universidad Autónoma de Bucaramanga. Status unknown at 1 site in Colombia. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by Universidad Autónoma de Bucaramanga · Phase 2/3, Interventional, and Treatment
Among 10 studies in Chagas Disease with a site in Colombia — 2 open to participants now, 3 under way, 1 of them phase 3. Chagas Disease · Colombia.
Among the 10 studies in Chagas Disease with a site in Colombia, this one is the only one that started in 2015, is the only one in phase 2/3, and was the 3rd registered.
73 studies on the registry are indexed under Chagas Disease; 5 are open to participants now.
This study's planned enrollment of 500 is above the median of 87 across 49 interventional studies indexed under Chagas Disease.
Browse Chagas Disease studies →2 of the 10 studies in Chagas Disease with a site in Colombia are open now, in 12 countries. Each count lists the studies.
Of the 3 Chagas Disease studies recruiting now, 1 (33%) set no upper age limit and 2 (67%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 20 Years to 55 Years · all sexes · no healthy volunteers.
The full table on the hub →10 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 1 started in 2015.
Median enrollment 238 across the 9 interventional studies, 50 across the 1 observational. Of the 5 that completed or were terminated, 2 (40%) have results posted.
6 of 10 have an industry lead sponsor. The 8 most frequent:
Universidad Autónoma de Bucaramanga is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Universidad Autónoma de Bucaramanga has 1 study filed under Chagas Disease — fewer than ten, so there is no comparison to draw.
2 of the studies in Chagas Disease with a site in Colombia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04024163Phase 3Insud PharmaProspective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease | 2027-08-30 |
| NCT06632600Novartis PharmaceuticalsA Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease. | 2027-07-22 |
Among the 10 studies in Chagas Disease with a site in Colombia, from their registry updates:
Nothing recorded among them since 2026-09-25.
This randomized, blind, parallel-group trial will evaluate the efficacy and safety of Nifurtimox (NFX) and Benznidazole (BZN), the two usual interventions to treat the parasite Trypanosoma cruzi.
The investigators will test whether NFX is an effective trypanocidal agent (by comparison with placebo) and equivalent to BZN (as active comparator) in terms of both parasite-related and safety outcomes.
Individuals found seropositive and without clinical signs of dilated cardiomyopathy will receive either of the active treatments or matching placebo. Participants allocated to NFX or BZN will receive either a 60-day (full-dose) or a 120-day (half-dose) active treatment, whereas the control group will receive placebo for 120 days. There will be thus four arms of active treatment (NFX60, NFX120, BZN60 and BZN120), and a fifth control arm receiving placebo (1:1:1:1:1 allocation ratio) where every participant in the trial will take 120 days of study drug (the groups receiving full-dose will complete a 120-day masked treatment with placebo).
The study plans to enroll 500 participants from Colombia (in two different geographical areas) and Argentina, in order to explore regional differences in the treatment effects.
The specific aims of this multi-center randomized trial include:
To evaluate the feasibility of conducting a multinational trial in terms of
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
60 days of active treatment with full-dose, or 120 days of active treatment with half-dose (allocation ratio 1:1). The 60-day group will receive active treatment in the first or second half of a 120-day treatment window, as per random allocation. The active treatment period will be followed/preceded by matching placebo (see placebo arm below)
Drug: Nifurtimox
60 days of active treatment with full-dose, or 120 days of active treatment with half-dose (allocation ratio 1:1). The 60-day group will receive active treatment in the first or second half of a 120-day treatment window, as per random allocation. The active treatment period will be followed/preceded by matching placebo (see placebo arm below)
Drug: Benznidazole
120 days of treatment with matching placebo
Drug: Placebo
Full dose: 8 mg/Kg/day, assuming an average weight of 60 Kg: 240 mg B.I.D Half-dose: 120 mg B.I.D
Also known as: Lampit (Bayer)
Full dose: 5 mg/Kg/day, assuming an average weight of 60 Kg: 150 mg B.I.D Half dose: 75 mg B.I.D
Also known as: Radanil (Roche), Rochagan (Roche), Abarax (ELEA)
Two capsules of matching placebo (contaning Magnesium stearate and cellulose) B.I.D
Also known as: Control group
Quantitative Polymerase Chain Reaction (qPCR) for Trypanosoma cruzi
Proportion of participants with at least one out of three positive tests (performed at least one week apart from each other)
Time frame: 12 - 18 months after starting therapy
T. cruzi positive serology status
Proportion of participants with positive T. cruyzi serology status
Time frame: 12 months after starting therapy
Mean change in T. cruzi antibody titers
Mean change (before-after) in antibody readings as measured with ELISA serology
Time frame: 12 months after starting therapy
Reported adverse reactions
Proportion of participants with at least one of the following a) Reporting hospitalization or inability to work b) Stopping study treatment because of adverse reactions /intolerance c) having abnormal levels of at least two biochemical or blood markers
Time frame: 60 days after starting therapy
Started Aug 2015 (actual). Primary completion is estimated for Aug 2018, 36 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nifurtimox
Universidad Autónoma de Bucaramanga