Chronic Chagas Disease, IndeterminatePhase 2NCT01489228
Proof-of-Concept Study of E1224 to Treat Adult Patients With Chagas Disease
A Phase 2 study testing E1224 and Benznidazole in people with Chronic Chagas Disease, Indeterminate, run by Drugs for Neglected Diseases at 2 sites in Bolivia.
Trial summary
This study will assess the safety and efficacy of E1224, a pro-drug of ravuconazole, in individuals with chronic indeterminate Chagas disease recruited in research centres in Tarija and Cochabamba, Bolivia. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chronic Chagas Disease, Indeterminate
- What is being tested?
- E1224 and Benznidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 230 participants
- Where
- 2 sitesBolivia
- Study dates
- Jun 2011to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed diagnosis of T. cruzi infection by serial qualitative PCR AND Conventional serology
- Women in reproductive age must have a negative serum pregnancy test at screening, must not be breastfeeding, and consistently use and/or have partner consistently use an adequate contraceptive method
- Normal ECG at screening
Who cannot join
- Abnormal laboratory test values at screening for the following parameters: total White Blood Cells (WBC) count, platelet count, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, or creatinine; or gamma-glutamyl transferase (GGT)
- History of alcohol abuse or any other drug addiction (as specified in the Study Manual of Operations)
- Any condition that prevents the patient from taking oral medication
- Any concomitant use of antimicrobial or antiparasitic agents
Trial locations and contacts
2 sites in 1 country.
Bolivia2 sites, 2 recruiting
- Recruiting
Plataforma de Atención Integral a los Pacientes con Enfermidad de Chagas
Cochabamba, Cochabamba
Faustino Torrico, PhD
Cristina Alonso, MD
- Recruiting
Plataforma de Atención Integral a los Pacientes con Enfermidad de Chagas
Tarija, Tarija Department
Lourdes Ortiz, MSc
Lourdes Ortiz, MSc
About this study
Official title: Phase 2 Randomized, Multicenter, Placebo-controlled, Safety and Efficacy Study to Evaluate Three Oral E1224 Dosing Regimens and Benznidazole for the Treatment of Adult Patients With Chronic Indeterminate Chagas Disease
This study will assess the safety and efficacy of E1224, a pro-drug of ravuconazole, in individuals with chronic indeterminate Chagas disease recruited in research centres in Tarija and Cochabamba, Bolivia.
Read the detailed description
Chagas disease (CD) ranks among the world's most neglected diseases. In Latin America, 21 countries are endemic for CD with an estimated 108 million people at risk of contracting the disease. Estimates from the 1980s indicated that some 16 million to 18 million individuals were infected. In the 1990s, after a series of multinational control initiatives, estimates of the number of infected people were revised to 9.8 million in 2001. The estimated burden of disease in terms of disability-adjusted life years (DALYs) declined from 2.7 million in 1990 to 586,000 in 2001. Recent estimates from Pan American Health Organization (PAHO, 2006) indicate 7.54 million infected people and 55,185 new cases per year.
The only two medicines available - benznidazole (BZN) and nifurtimox (NFX) - are known to cause serious toxicity with unsatisfactory cure rates, especially when used in adult chronic CD patients.
Novel antifungal triazole derivatives have arisen as alternative treatments for CD. They inhibit T. cruzi ergosterol biosynthesis, which is essential for parasite growth and survival, and have pharmacokinetic properties suitable for the treatment of this disseminated intracellular infection. Several triazole derivatives have been tested in animal models of CD, including D08701, posaconazole, ravuconazole (RAV), albaconazole, and TAK-187. In particular, RAV has previously been shown to have potent in vitro and in vivo activities, inducing parasitological cure in mice with acute infections, including those caused by benznidazole-resistant strains of T. cruzi. Suppressive activity was also seen in dog models.
E1224 is a water-soluble monolysine salt form of the RAV pro-drug. It is a broad-spectrum triazole antifungal with in vitro activity against most Candida and Aspergillus species, some non-Aspergillus species of filamentous fungi, Cryptococcus, dermatophytes, and fungi that cause the endemic mycoses.
RAV was evaluated extensively in animal models and in human trials including Phase 2 safety and efficacy trials in oropharyngeal and esophageal candidiasis and onychomycosis, and for prevention of invasive fungal infections in hematopoietic stem cell transplant recipients.
With the benign safety profile and the encouraging results of animal studies and favorable pharmacokinetics, E1224 is considered a priority candidate for clinical development for the treatment of Chagas' disease.
The general objective of this phase II trial is to determine whether each of three different dosing regimens of E1224 are efficacious and safe in eradicating T. cruzi parasitemia in individuals with the chronic indeterminate form of CD, in comparison to placebo.
- Conditions
- Chronic Chagas Disease, Indeterminate
- Being tested
- E1224, Benznidazole, Placebo
- Keywords
- Chagas Disease
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E1224Drug
Also called E1224 (prodrug for active ingredient Ravuconazole)
100 mg tablets
BenznidazoleDrug
Also called Benznidazole (N-benzil-2-nitro-1-imidazolacetamida)
100mg tablets
PlaceboDrug
tablets
| Study group | Role | What they receive |
|---|---|---|
| High Dose E1224 | Experimental | High Dose (HD - 8weeks) Group Receives: Drug: E1224 |
| Low Dose E1224 | Experimental | Low Dose (LD - 8 weeks) Group Receives: Drug: E1224 |
| Short Dose E1224 | Experimental | Short Dose (SD - 4 weeks) Group Receives: Drug: E1224 |
| Placebo | Placebo comparator | Placebo (8 weeks) Group Receives: Drug: Placebo |
| Benznidazol | Active comparator | BZN (Laboratório do Estado de Pernambuco -LAFEPE, tablet 100mg), 5 mg/Kg/day PO divided in two daily doses, for 60 days Receives: Drug: Benznidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serial negative qualitative Polymerase Chain Reaction (PCR) results (3 negative PCR results from 3 samples to be collected over 7 days) as a measure of parasitological cure at end of treatment
To determine whether at least one of three dosing regimens of orally administered E1224 is more efficacious than placebo in individuals with chronic indeterminate CD, by determining the number of patients who convert from positive to negative in serial, qualitative PCR test results
Measured: Day 65 (end of treatment)
Secondary outcomes (10)
Consistently negative serial qualitative PCR as a measure of sustained parasitological eradication
Measured: 4, 6 and 12 months follow-up
Qualitative PCR as a measure of parasite eradication
Measured: Day 8, 15, 36 , 65 and at 4, 6 and 12 months follow-up
Quantitative PCR as a measure of change in parasite load over time
Measured: Day 8, 15, 36, 65 and at 4, 6 and 12 months follow-up
Incidence of serological conversion to negative and changes in titers over time as measured by conventional and non-conventional serologies
Measured: Day 65 and at 4, 6 and 12 months after treatment
Changes in the levels of biomarkers over time: brain natriuretic peptide, troponin T, selected prothrombotic factors, lytic antibodies, apolipoprotein A1 and multiplex serodiagnostic assay
Measured: Day 36 , 65 and at 4, 6 and 12 months follow-up
Area under the plasma concentration versus time curve (AUC), Peak Plasma Concentration (Cmax), Minimum Plasma Concentration (Cmin), Clearance, Volume of Distribution , and Plasma Terminal Half-Life (t1/2) of ravuconazole and benznidazole
Samples for population pharmacokinetics parameters of ravuconazole and benznidazole will be collected at randomly selected time points on Days 1, 2 and 3.
Measured: Day 0 (pre-dose), Day 1 (after 1st dose), Day 2, Day 3, steady-state phase (D8-D50), at the end of treatment (D65) and at the 4 months follow-up visit
Incidence and severity of adverse events (clinical and laboratory)
Measured: Up to 12 months follow-up
Incidence of Serious Adverse Events and/or adverse events leading to treatment discontinuation
Measured: Up to 12 months follow-up
Early and late predictors of sustainable response to treatments
Measured: Up to 12 months follow-up
Correlation of pharmacokinetic parameters with parasitological response, changes in biomarkers and safety outcomes
Measured: Day 8, 15, 36, 65, and at 4, 6 months and 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2012 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Chagas Disease, IndeterminateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drugs for Neglected Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- Eisai Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Isabela Ribeiro, MD, Study director, Drugs for Neglected Diseases initiativeFaustino Torrico, PhD, Principal investigator, Universidad Mayor San Simón. Cochabamba, Bolivia.Joaquim Gascón, PhD, Principal investigator, CRESIB - Centre de Recerca en Salut Internacional de Barcelona, Spain.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489228
- Sponsor's protocol ID
- DNDi-CH-E1224-001
- Status last verified
- Dec 2011
- First submitted
- 24 Nov 2011
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
De Salazar PM, Sosa-Estani S, Salvador F, Sulleiro E, Sanchez-Montalva A, Ribeiro I, Molina I, Buckee CO. Human Trypanosoma cruzi chronic infection leads to individual level steady-state parasitemia: Implications for drug-trial optimization in Chagas disease. PLoS Negl Trop Dis. 2022 Nov 21;16(11):e0010828. doi: 10.1371/journal.pntd.0010828. eCollection 2022 Nov.
PubMed 36409773Parrado R, Ramirez JC, de la Barra A, Alonso-Vega C, Juiz N, Ortiz L, Illanes D, Torrico F, Gascon J, Alves F, Flevaud L, Garcia L, Schijman AG, Ribeiro I. Usefulness of Serial Blood Sampling and PCR Replicates for Treatment Monitoring of Patients with Chronic Chagas Disease. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e01191-18. doi: 10.1128/AAC.01191-18. Print 2019 Feb.
PubMed 30509941Torrico F, Gascon J, Ortiz L, Alonso-Vega C, Pinazo MJ, Schijman A, Almeida IC, Alves F, Strub-Wourgaft N, Ribeiro I; E1224 Study Group. Treatment of adult chronic indeterminate Chagas disease with benznidazole and three E1224 dosing regimens: a proof-of-concept, randomised, placebo-controlled trial. Lancet Infect Dis. 2018 Apr;18(4):419-430. doi: 10.1016/S1473-3099(17)30538-8. Epub 2018 Jan 16.
PubMed 29352704
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized, Multicenter, Placebo-controlled, Safety and Efficacy Study to Evaluate Three Oral E1224 Dosing Regimens and Benznidazole for the Treatment of Adult Patients With Chronic Indeterminate Chagas Disease
- ClinicalTrials.gov ID
- NCT01489228
- Acronym / sponsor ID
- DNDi-CH-E1224-001
- Conditions
- Chronic Chagas Disease, Indeterminate
- Keywords
- Chagas Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Drugs for Neglected DiseasesUniversity, hospital or other
- Collaborators
- Eisai Co., Ltd.
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 9 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and efficacy of E1224, a pro-drug of ravuconazole, in individuals with chronic indeterminate Chagas disease recruited in research centres in Tarija and Cochabamba, Bolivia.
Detailed description
Chagas disease (CD) ranks among the world's most neglected diseases. In Latin America, 21 countries are endemic for CD with an estimated 108 million people at risk of contracting the disease. Estimates from the 1980s indicated that some 16 million to 18 million individuals were infected. In the 1990s, after a series of multinational control initiatives, estimates of the number of infected people were revised to 9.8 million in 2001. The estimated burden of disease in terms of disability-adjusted life years (DALYs) declined from 2.7 million in 1990 to 586,000 in 2001. Recent estimates from Pan American Health Organization (PAHO, 2006) indicate 7.54 million infected people and 55,185 new cases per year.
The only two medicines available - benznidazole (BZN) and nifurtimox (NFX) - are known to cause serious toxicity with unsatisfactory cure rates, especially when used in adult chronic CD patients.
Novel antifungal triazole derivatives have arisen as alternative treatments for CD. They inhibit T. cruzi ergosterol biosynthesis, which is essential for parasite growth and survival, and have pharmacokinetic properties suitable for the treatment of this disseminated intracellular infection. Several triazole derivatives have been tested in animal models of CD, including D08701, posaconazole, ravuconazole (RAV), albaconazole, and TAK-187. In particular, RAV has previously been shown to have potent in vitro and in vivo activities, inducing parasitological cure in mice with acute infections, including those caused by benznidazole-resistant strains of T. cruzi. Suppressive activity was also seen in dog models.
E1224 is a water-soluble monolysine salt form of the RAV pro-drug. It is a broad-spectrum triazole antifungal with in vitro activity against most Candida and Aspergillus species, some non-Aspergillus species of filamentous fungi, Cryptococcus, dermatophytes, and fungi that cause the endemic mycoses.
RAV was evaluated extensively in animal models and in human trials including Phase 2 safety and efficacy trials in oropharyngeal and esophageal candidiasis and onychomycosis, and for prevention of invasive fungal infections in hematopoietic stem cell transplant recipients.
With the benign safety profile and the encouraging results of animal studies and favorable pharmacokinetics, E1224 is considered a priority candidate for clinical development for the treatment of Chagas' disease.
The general objective of this phase II trial is to determine whether each of three different dosing regimens of E1224 are efficacious and safe in eradicating T. cruzi parasitemia in individuals with the chronic indeterminate form of CD, in comparison to placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| High Dose E1224 | Experimental | Drug: E1224High Dose (HD - 8weeks) Group |
| Low Dose E1224 | Experimental | Drug: E1224Low Dose (LD - 8 weeks) Group |
| Short Dose E1224 | Experimental | Drug: E1224Short Dose (SD - 4 weeks) Group |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (8 weeks) Group |
| Benznidazol | Active comparator | Drug: BenznidazoleBZN (Laboratório do Estado de Pernambuco -LAFEPE, tablet 100mg), 5 mg/Kg/day PO divided in two daily doses, for 60 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of T. cruzi infection by serial qualitative PCR AND Conventional serology
- Women in reproductive age must have a negative serum pregnancy test at screening, must not be breastfeeding, and consistently use and/or have partner consistently use an adequate contraceptive method
- Normal ECG at screening
Key exclusion criteria (4 listed)
- Abnormal laboratory test values at screening for the following parameters: total White Blood Cells (WBC) count, platelet count, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, or creatinine; or gamma-glutamyl transferase (GGT)
- History of alcohol abuse or any other drug addiction (as specified in the Study Manual of Operations)
- Any condition that prevents the patient from taking oral medication
- Any concomitant use of antimicrobial or antiparasitic agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| E1224Also: E1224 (prodrug for active ingredient Ravuconazole)100 mg tablets | Drug | High Dose E1224, Low Dose E1224, Short Dose E1224 |
| BenznidazoleAlso: Benznidazole (N-benzil-2-nitro-1-imidazolacetamida)100mg tablets | Drug | Benznidazol |
| Placebotablets | Drug | Placebo |
Primary outcome
Serial negative qualitative Polymerase Chain Reaction (PCR) results (3 negative PCR results from 3 samples to be collected over 7 days) as a measure of parasitological cure at end of treatment
Time frame: Day 65 (end of treatment)
To determine whether at least one of three dosing regimens of orally administered E1224 is more efficacious than placebo in individuals with chronic indeterminate CD, by determining the number of patients who convert from positive to negative in serial, qualitative PCR test results
10 secondary outcomes
Consistently negative serial qualitative PCR as a measure of sustained parasitological eradication
Time frame: 4, 6 and 12 months follow-up
Qualitative PCR as a measure of parasite eradication
Time frame: Day 8, 15, 36 , 65 and at 4, 6 and 12 months follow-up
Quantitative PCR as a measure of change in parasite load over time
Time frame: Day 8, 15, 36, 65 and at 4, 6 and 12 months follow-up
Incidence of serological conversion to negative and changes in titers over time as measured by conventional and non-conventional serologies
Time frame: Day 65 and at 4, 6 and 12 months after treatment
Changes in the levels of biomarkers over time: brain natriuretic peptide, troponin T, selected prothrombotic factors, lytic antibodies, apolipoprotein A1 and multiplex serodiagnostic assay
Time frame: Day 36 , 65 and at 4, 6 and 12 months follow-up
Area under the plasma concentration versus time curve (AUC), Peak Plasma Concentration (Cmax), Minimum Plasma Concentration (Cmin), Clearance, Volume of Distribution , and Plasma Terminal Half-Life (t1/2) of ravuconazole and benznidazole
Time frame: Day 0 (pre-dose), Day 1 (after 1st dose), Day 2, Day 3, steady-state phase (D8-D50), at the end of treatment (D65) and at the 4 months follow-up visit
Incidence and severity of adverse events (clinical and laboratory)
Time frame: Up to 12 months follow-up
Incidence of Serious Adverse Events and/or adverse events leading to treatment discontinuation
Time frame: Up to 12 months follow-up
Early and late predictors of sustainable response to treatments
Time frame: Up to 12 months follow-up
Correlation of pharmacokinetic parameters with parasitological response, changes in biomarkers and safety outcomes
Time frame: Day 8, 15, 36, 65, and at 4, 6 months and 12 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2011.
- Derived from this study: PubMed 36409773De Salazar PM, Sosa-Estani S, Salvador F, Sulleiro E, Sanchez-Montalva A, Ribeiro I, Molina I, Buckee CO. Human Trypanosoma cruzi chronic infection leads to individual level steady-state parasitemia: Implications for drug-trial optimization in Chagas disease. PLoS Negl Trop Dis. 2022 Nov 21;16(11):e0010828. doi: 10.1371/journal.pntd.0010828. eCollection 2022 Nov.
- Derived from this study: PubMed 30509941Parrado R, Ramirez JC, de la Barra A, Alonso-Vega C, Juiz N, Ortiz L, Illanes D, Torrico F, Gascon J, Alves F, Flevaud L, Garcia L, Schijman AG, Ribeiro I. Usefulness of Serial Blood Sampling and PCR Replicates for Treatment Monitoring of Patients with Chronic Chagas Disease. Antimicrob Agents Chemother. 2019 Jan 29;63(2):e01191-18. doi: 10.1128/AAC.01191-18. Print 2019 Feb.
- Derived from this study: PubMed 29352704Torrico F, Gascon J, Ortiz L, Alonso-Vega C, Pinazo MJ, Schijman A, Almeida IC, Alves F, Strub-Wourgaft N, Ribeiro I; E1224 Study Group. Treatment of adult chronic indeterminate Chagas disease with benznidazole and three E1224 dosing regimens: a proof-of-concept, randomised, placebo-controlled trial. Lancet Infect Dis. 2018 Apr;18(4):419-430. doi: 10.1016/S1473-3099(17)30538-8. Epub 2018 Jan 16.
- Drugs for Neglected Diseases initiativeLink provided by the sponsor.
Related trials for Chronic Chagas Disease, Indeterminate
RecruitingPhase 2
A Study of Efficacy, Safety, Tolerability of LXE408 in Participants With Chronic Chagas Disease.
Chagas Disease
Active, not recruitingPhase 3
Prospective Study of Benznidazole for Chagas' Disease Children With Chronic Indeterminate Chagas Disease
Chagas Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabela Ribeiro, MD study director
Drugs for Neglected Diseases initiative
Faustino Torrico, PhD principal investigator
Universidad Mayor San Simón. Cochabamba, Bolivia.
Joaquim Gascón, PhD principal investigator
CRESIB - Centre de Recerca en Salut Internacional de Barcelona, Spain.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing E1224 and Benznidazole in people with Chronic Chagas Disease, Indeterminate, run by Drugs for Neglected Diseases at 2 sites in Bolivia.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 21 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabiana P Alves, PhD (+552122152941, falves@dndi.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serial negative qualitative Polymerase Chain Reaction (PCR) results (3 negative PCR results from 3 samples to be collected over 7 days) as a measure of parasitological cure at end of treatment (time frame: Day 65 (end of treatment)). 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 NCT01489228, which also lists 3 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 21 Dec 2011.