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AzTrials

Chagas DiseasePhase 3NCT02625974

A Study to Learn How Well Nifurtimox Works and How Safe it is in Children Aged 0 to 17 Years With Chagas' Disease, an Inflammatory, Infectious Disease Caused by the Parasite Trypanosoma Cruzi

A Phase 3 study testing Nifurtimox (Lampit, BAYA2502) in people with Chagas Disease, run by Bayer at 25 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Researchers are looking for a better way to treat children who have an infectious disease caused by the parasite Trypanosoma cruzi (Chagas' disease). Chagas'disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Chagas Disease
What is being tested?
Nifurtimox (Lampit, BAYA2502)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
330 participants
Where
25 sitesin 3 countries
Study dates
27 Jan 2016to 10 Aug 2021
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Part 1:
  • Male and female pediatric subjects aged 0 days to younger than 18 years
  • Chagas' disease diagnosed/ confirmed for a) Subjects < 8 months of age at randomization must demonstrate direct observation of Trypanosoma cruzi by concentration test; b) Subjects ≥ 8 months to < 18 years of age at randomization must demonstrate a positive conventional ELISA result for both recombinant ELISA and total purified antigen ELISA
  • Part 2:
  • Male and female subjects who were randomized and received at least one dose of their assigned 60- or 30-day regimen of nifurtimox treatment

Who cannot join

  • Part 1:
  • Subjects aged 0 to 27 days who, at birth, were pre-term, weighed less than 2500 g, or had a maximum Apgar score < 7 at 5 minutes
  • Known evidence of Chagas' disease-related cardiomyopathy/ Chagas' heart disease
  • Known evidence of Chagas' disease-related gastrointestinal dysfunction (e.g. megaoesophagus, megacolon, or both) or Chagas' digestive disease
  • Serious manifestations of acute Chagas' disease, including myocarditis, meningoencephalitis, or pneumonitis
  • Known evidence of Chagas' disease-related damage to the peripheral nervous system or peripheral neuropathy
Show all 15Show fewer
  • Clinically significant psychiatric disorder (e.g. moderate to severe depression, severe anxiety, or psychosis) or epilepsy
  • Subjects with contraindications/ warnings to nifurtimox administration, or with conditions that may increase the risk of the undesirable effects of nifurtimox
  • Subjects who have had previous treatment with trypanocidal agents or an accepted indication for antiparasitic therapy (e.g. reactivation of Chagas' infection due to immunosuppression by several diseases or treatment with steroids)
  • Subjects living in housing conditions where there is no active or effective vector control to Trypanosoma cruzi reinfection as determined by Ministry of Health guidelines in each country
  • Part 2:
  • Subjects with acute or chronic health conditions or congenital disorders which, in the opinion of the investigator, would make them unsuitable for participation in the clinical study
  • Subjects living in housing conditions where there is no active or effective vector-control to Trypanosoma cruzi reinfection as determined by Ministry of Health guideline of the respective country
  • Subjects with clinical manifestations of Chagas' disease-related gastrointestinal dysfunction or serious manifestations of acute Chagas' disease
  • Immuno-compromised subjects (e.g. with human immunodeficiency virus or treated with immunosuppressive drugs)

Trial locations and contacts

25 sites in 3 countries.

25 sites in 3 countries

Argentina18 sites

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, 1281

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1270AAN

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1425AGP

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1425EFD

  • Study site

    Corrientes, W3400CBI

  • Study site

    Formosa, P3600HZL

  • Study site

    La Plata, Buenos Aires, 1900

  • Study site

    La Rioja

  • Study site

    Mendoza, 5500

  • Study site

    Mendoza, 5535

  • Study site

    Posadas, Misiones Province

  • Study site

    Rosario, Santa Fe Province, 2000

  • Study site

    Salta, 4400

  • Study site

    Salta, A4400ESE

  • Study site

    San Juan, 5400

  • Study site

    San Miguel de Tucumán, 4000

  • Study site

    San Salvador de Jujuy, Jujuy Province, 4600

  • Study site

    Santiago del Estero, 4202

Other trials in Argentina

Colombia4 sites

  • Study site

    Floridablabca, Santander Department, 681011

  • Study site

    Santa Marta, Magdalena Department, 0

  • Study site

    Soledad, Atlántico

  • Study site

    Yopal, Casanare Department, 0

Other trials in Colombia

Bolivia3 sites

  • Study site

    Cochabamba

  • Study site

    Punata

  • Study site

    Tarija

Other trials in Bolivia

About this study

Official title: Prospective, Historically Controlled Study to Evaluate the Efficacy and Safety of a New Pediatric Formulation of Nifurtimox in Children Aged 0 to 17 Years With Chagas' Disease

Researchers are looking for a better way to treat children who have an infectious disease caused by the parasite Trypanosoma cruzi (Chagas' disease).

Chagas'disease is an inflammatory, infectious disease caused by the parasite Trypanosoma cruzi. This parasite is mainly spread by insects called triatomine bug. If Chagas' disease is left untreated, it can later cause serious heart and digestive problems.

Read more

The study treatment nifurtimox has been used for more than 50 years to treat Chagas' disease. When used early after infection, it kills the parasite. In people who have long-term Chagas' disease, it's no longer possible to kill the parasite. However, nifurtimox may help slow the progression of the disease and its most serious complications.

Nifurtimox was developed for use in adults only, but has also been used in children (off-label) for over 40 years. Currently it is available for doctors to give to adults and to children. However, there are not enough data about nifurtimox in children.

The main purpose of this study is to learn how well nifurtimox works in children aged 8 months to less than 18 years with Chagas' disease. To answer this, the researchers will compare the amount of antibodies against the parasite Trypanosoma cruzi in the serum (fluid from blood without the clotting factors) between children treated with nifurtimox for 60 days with untreated children from the past (control group):

  • 12 months and
  • 4 years after the end of treatment. The data for the control group will come from 2 previous studies conducted in children.
Conditions
Chagas Disease
Being tested
Nifurtimox (Lampit, BAYA2502), Placebo
Medical subject headings
Chagas Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nifurtimox (Lampit, BAYA2502)Drug

    For pediatric participants with body weight ≤ 40 kg: dosage 10 to 20 mg/kg/day in three divided doses.

    For pediatric participants with body weight > 40 kg: 8 - 10 mg/kg/day in three divided doses.

    60 days or 30 days of nifurtimox treatment

  • PlaceboDrug

    Matching placebo

Study groups in NCT02625974
Study groupRoleWhat they receive
Nifurtimox 60 days / Arm 1ExperimentalNifurtimox tablets administered three times daily for 60 days (Days 1 - 60, active nifurtimox treatment)
Receives: Drug: Nifurtimox (Lampit, BAYA2502)
Nifurtimox 30 days / Arm 2ExperimentalNifurtimox tablets administered three times daily for 30 days, followed by placebo administered three times daily for 30 days (Days 1 - 30, active nifurtimox treatment; Days 31 - 60, placebo)
Receives: Drug: Nifurtimox (Lampit, BAYA2502); Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects)

    Cure is defined as sero-reduction (in subjects ≥8 months to <18 years of age at randomization) or sero-conversion (in all subjects). Sero-reduction is defined as a ≥20% reduction in optical density [OD]) measured by two conventional ELISA serology tests and sero-conversion is defined as negative Immunoglobulin G (IgG) concentration measured by two conventional ELISA serology tests.

    Subjects who have missing conventional serology results at the 12 month time point were treated as failures (ie, no cure).

    For the primary objective in the study, superiority over placebo was confirmed if the lower limit of the 95% Confidence Interval (CI) for the nifurtimox (60-day regimen) cure rate is greater than 16%, the larger of the upper limits of the 95% CIs for historical placebo control.

    Measured: At 12 months post-treatment

  2. Part 2 - Incidence Rate of Seronegative Conversion in Subjects Received at Least One Dose of the 60-day Nifurtimox Treatment Regimen.

    Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay [IHA]) in subjects who were randomized and received at least one dose of the 60-day nifurtimox treatment regimen compared to an external control group of historical placebo patients with Chagas' disease. Incidence rate is the number of new cases of seronegative conversion over the study period (i.e., 4 years after end of nifurtimox treatment) divided by the person-time at risk. It was modelled using a Poisson distribution with a 2-sided 95% exact CI.

    Number of participants with events were reported.

    Measured: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

Secondary outcomes (34)

  1. Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 2

    Measured in sub-population.

    Measured: At Visit 2 (Day 1): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours

  2. Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 3

    Measured in sub-population.

    Measured: At Visit 3 (Day 7): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours

  3. Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 6

    The evaluation was based on clinical examinations. Measured in sub-population.

    Measured: At Visit 6 (Day 30): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours

  4. Part 1 - Nifurtimox Concentration Over Time in Plasma at Visit 8

    Measured in sub-population.

    Measured: At Visit 8 (Day 60): Pre-dose and Post-dose at 5-10 minutes, 10-120 minutes, 2-4 hours, and 4-8 hours

  5. Part 2 - Incidence Rate of Seronegative Conversion in Subjects Who Received at Least One Dose of the 30-day Nifurtimox Treatment Regimen

    Seronegative conversion measured by two types of assay (recombinant ELISA and indirect hemagglutination assay [IHA]) in subjects who were randomized and received at least one dose of the 30-day nifurtimox treatment regimen. Incidence rate is the number of new cases of seronegative conversion over the study period (i.e., 4 years after end of nifurtimox treatment) divided by the person-time at risk. It was modelled using a Poisson distribution with a 2-sided 95% exact CI.

    Number of participants with events were reported.

    Measured: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

  6. Part 2 - ECG Signs of Established Chagas-related Cardiomyopathy

    Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by electrocardiogram (ECG).

    Evidence of established Chagas-related cardiomyopathy: Total

    Measured: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

  7. Part 2 - Serological Response of Established Chagas-related Cardiomyopathy

    Summary of subjects by evidence of established Chagas-related cardiomyopathy as measured by Serological response.

    Evidence of established Chagas-related cardiomyopathy: Total

    Measured: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

  8. Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Total Purified Antigen ELISA

    Summary and change from baseline of optical density values measured by total purified antigen ELISA.

    Optical density is the measure of absorbance, and is defined as the ratio of the intensity of light falling upon a material and the intensity transmitted.

    Measured: Baseline and Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

  9. Part 1 + Part 2 - Serial Reduction of Optical Density Values Measured by Recombinant ELISA

    Summary and change from baseline of optical density values measured by recombinant ELISA.

    Optical density is the measure of absorbance, and is defined as the ratio of the intensity of light falling upon a material and the intensity transmitted.

    Measured: Baseline and Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

  10. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 1

    The evaluation was based on clinical examinations.

    Measured: At Visit 1 (before treatment started)

  11. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 3

    The evaluation was based on clinical examinations.

    Measured: Up to 7 days (Visit 3)

  12. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 6

    The evaluation was based on clinical examinations.

    Measured: Up to 30 days (Visit 6)

  13. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 8

    The evaluation was based on clinical examinations.

    Measured: Up to 60 days (Visit 8; end of treatment)

  14. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 9

    The evaluation was based on clinical examinations.

    Measured: Up to 90 days (Visit 9 post-treatment)

  15. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 10

    The evaluation was based on clinical examinations.

    Measured: Up to 240 days (Visit 10 post-treatment)

  16. Part 1 - Number of Subjects With Clinical Signs/ Symptoms of Chagas Disease at Visit 11

    The evaluation was based on clinical examinations.

    Measured: Up to 420 days (Visit 11 post-treatment)

  17. Part 1 - Number of Subjects With Positive Results in Concentration Test for T. Cruzi (for Subjects <8 Months of Age)

    Measured: Up to 90 days (Visit 9 post-treatment)

  18. Part 1 - Number of Subjects With a Positive Serological Response Using Non-conventional Enzyme-linked Immunosorbent Assay-F29 (ELISAF29) Test

    The non-conventional ELISA-F29 test is considered an early marker of treatment efficacy in chronic Chagas disease.

    Measured: Up to 420 days (Visit 11 post-treatment)

  19. Part 1 - Number of Subjects With Positive Quantitative Polymerase Chain Reaction (qPCR) Results

    The qPCR is molecular technique, considered a tool to diagnose acute and congenital Chagas disease, as well as a marker to measure treatment failure when demonstrating positive (detectable) results

    Measured: Up to 420 days (Visit 11 post-treatment)

  20. Part 1 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    TEAEs comprised events which first occurred or worsened at or after first application of study drug during the course of the study up to and including 7 days after last application of study drug

    Measured: up to 7 days after last application of study drug

  21. Part 2 - Number of Subjects With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)

    TEAEs comprised events which first occurred or worsened at study start up to end of study in part 2.

    In Part 2, only AEs considered at least possibly related to nifurtimox (administered in part 1) and those caused by protocol-related procedures were reported.

    Measured: Subjects participating in Part 2 were followed up for another 3 years, for a total follow-up period of 4 years after end of nifurtimox treatment in Part 1

  22. Part 1 - Number of Subjects With Treatment-emergent High Blood Chemistry Abnormalities by Treatment

    The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment.

    The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline.

    Measured: Up to 420 days (Visit 11 post-treatment)

  23. Part 1 - Number of Subjects With Treatment-emergent Low Blood Chemistry Abnormalities by Treatment

    The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment.

    The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline.

    Measured: Up to 420 days (Visit 11 post-treatment)

  24. Part 1 - Number of Subjects With Treatment-emergent High Hematology Abnormalities by Treatment

    The number analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. Subjects with missing or high abnormal values at baseline are not included in the number analyzed.

    The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline.

    Measured: Up to 420 days (Visit 11 post-treatment)

  25. Part 1 - Number of Subjects With Treatment-emergent Low Hematology Abnormalities by Treatment

    The number analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment. Subjects with missing or low abnormal values at baseline are not included in the number analyzed.

    The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline.

    Measured: Up to 420 days (Visit 11 post-treatment)

  26. Part 1 - Number of Subjects With Treatment-emergent High Coagulation Abnormalities by Treatment

    The Number Analyzed represents the number of subjects at baseline with a normal or lower than normal laboratory assessment who also had at least one valid laboratory value after start of treatment.

    The number of subjects represents subjects with at least one high laboratory assessment after start of treatment who had a normal or lower than normal laboratory assessment at baseline.

    Measured: Up to 420 days (Visit 11 post-treatment)

  27. Part 1 - Number of Subjects With Treatment-emergent Low Coagulation Abnormalities by Treatment

    The number analyzed represents the number of subjects at baseline with a normal or higher than normal laboratory assessment who also had at least one valid laboratory value after start of treatment.

    The number of subjects represents subjects with at least one low laboratory assessment after start of treatment who had a normal or higher than normal laboratory assessment at baseline.

    Measured: Up to 420 days (Visit 11 post-treatment)

  28. Part 1 - Number of Subjects With Abnormal Urinalysis Findings Considered as Clinically Significant or Reported as Adverse Events (AEs)

    Urinalysis was performed and the following parameters evaluated: bilirubin, blood (red blood cells, white blood cells), chorionic gonadotropin β, glucose, ketones, leukocytes, nitrite, pH, protein, specific gravity, and urobilinogen.

    Measured: Up to 420 days (Visit 11 post-treatment)

  29. Part 1 - Number of Subjects With Abnormal ECG Findings Considered as Clinically Significant by Investigators

    Clinical significance of abnormal ECG was based on the judgement of the investigator

    Measured: Up to 420 days (Visit 11 post-treatment)

  30. Part 1 - Mean Changes in Vital Signs (Systolic Blood Pressure) Between the Treatment Groups From Baseline

    Systolic Blood Pressure

    Measured: Baseline and up to 420 days (Visit 11 post-treatment)

  31. Part 1 - Mean Changes in Vital Signs (Diastolic Blood Pressure) Between the Treatment Groups From Baseline

    Diastolic Blood Pressure

    Measured: Baseline and up to 420 days (Visit 11 post-treatment)

  32. Part 1 - Mean Changes in Vital Signs (Respiratory Rate) Between the Treatment Groups From Baseline

    Respiratory Rate

    Measured: Baseline and up to 420 days (Visit 11 post-treatment)

  33. Part 1 - Mean Changes in Vital Signs (Heart Rate) Between the Treatment Groups From Baseline

    Heart Rate

    Measured: Baseline and up to 420 days (Visit 11 post-treatment)

  34. Part 1 - Mean Changes in Vital Signs (Body Temperature) Between the Treatment Groups From Baseline

    Temperature

    Measured: Baseline and up to 420 days (Visit 11 post-treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2015 (estimated)
  2. Study start27 Jan 2016
  3. Primary completion25 Jul 2018
  4. Study completion10 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
330 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02625974
Sponsor's protocol ID
16027
Other IDs
2022-001504-17
Status last verified
Mar 2024
First submitted
7 Dec 2015
Last updated
19 Aug 2024
Data monitoring committee
Yes
FDA-regulated device
No

Publications

  • Sosa Estani S, Segura EL, Ruiz AM, Velazquez E, Porcel BM, Yampotis C. Efficacy of chemotherapy with benznidazole in children in the indeterminate phase of Chagas' disease. Am J Trop Med Hyg. 1998 Oct;59(4):526-9. doi: 10.4269/ajtmh.1998.59.526.

    PubMed 9790423

  • de Andrade AL, Zicker F, de Oliveira RM, Almeida Silva S, Luquetti A, Travassos LR, Almeida IC, de Andrade SS, de Andrade JG, Martelli CM. Randomised trial of efficacy of benznidazole in treatment of early Trypanosoma cruzi infection. Lancet. 1996 Nov 23;348(9039):1407-13. doi: 10.1016/s0140-6736(96)04128-1.

    PubMed 8937280

  • Altcheh J, Castro L, Dib JC, Grossmann U, Huang E, Moscatelli G, Pinto Rocha JJ, Ramirez TE; CHICO Study Group. Prospective, historically controlled study to evaluate the efficacy and safety of a new paediatric formulation of nifurtimox in children aged 0 to 17 years with Chagas disease one year after treatment (CHICO). PLoS Negl Trop Dis. 2021 Jan 7;15(1):e0008912. doi: 10.1371/journal.pntd.0008912. eCollection 2021 Jan.

    PubMed 33412557

  • Rivero R, Esteva MI, Huang E, Colmegna L, Altcheh J, Grossmann U, Ruiz AM; CHICO and CHICO SECURE Study Groups. ELISA F29 -A therapeutic efficacy biomarker in Chagas disease: Evaluation in pediatric patients treated with nifurtimox and followed for 4 years post-treatment. PLoS Negl Trop Dis. 2023 Jun 23;17(6):e0011440. doi: 10.1371/journal.pntd.0011440. eCollection 2023 Jun.

    PubMed 37352322

  • Altcheh J, Sierra V, Ramirez T, Pinto Rocha JJ, Grossmann U, Huang E, Moscatelli G, Ding O. Efficacy and Safety of Nifurtimox in Pediatric Patients with Chagas Disease: Results at 4-Year Follow-Up in a Prospective, Historically Controlled Study (CHICO SECURE). Antimicrob Agents Chemother. 2023 Apr 18;67(4):e0119322. doi: 10.1128/aac.01193-22. Epub 2023 Mar 28.

    PubMed 36975790

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nifurtimox (Lampit, BAYA2502) in people with Chagas Disease, run by Bayer at 25 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Argentina, Colombia, Bolivia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1 - Percentage of Sero-reduction or Sero-conversion (Cured Subjects) (time frame: At 12 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02625974, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024; AzTrials last refreshed its copy on 26 Oct 2026.

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