Chagas DiseasePhase 4CINEBENZNCT01755403
Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease
A Phase 4 study testing Benznidazole in people with Chagas Disease, run by Barcelona Centre for International Health Research at 1 site in Spain.
Trial summary
o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chagas Disease
- What is being tested?
- Benznidazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2012to Nov 2013
- Phase
- Phase 4
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult patients with Chronic Chagas Disease diagnosed by 2 different and positive serological tests.
- Patients with Chronic Chagas Disease who are going to start treatment with Benznidazole.
- Any gender.
- All the participants must agree to participate in the study and must sign the informed consent.
Who cannot join
- Patients younger than 18.
- Patients with previous hypersensitivity to Benznidazole.
- Immunocompromised patients as AIDS, cancer, chemotherapy, longterm corticoids need, primary immunodeficiency, or any other.
- Hepatic dysfunction
- Renal dysfunction: serum creatinin higher than 3 mg/dl.
- Pregnancy or lactation.
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- Low adhesion to treatment or check-up.
- Impossibility of follow-up.
- Severe adverse reaction to Benznidazole.
- Any other situation that could be risky for the patient.
Trial locations and contacts
1 site in 1 country.
Spain1 site
International Health Department, Hospital Clinic, Barcelona
Barcelona, Catalonia, 08036
About this study
Official title: Population Pharmacokinetics in Benznidazole-treated Adults With Chronic Chagas Disease. Benznidazole Pharmacokinetics and Adverse Reactions Relationship.
- study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.
- Conditions
- Chagas Disease
- Being tested
- Benznidazole
- Medical subject headings
- Chagas Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BenznidazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| Benznidazole | Other | Not described Receives: Drug: Benznidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Population pharmacokinetic parameters of Benznidazole
Population pharmacokinetic model development
Measured: 2 months (treatment period)
Secondary outcomes (1)
Adverse reactions
Number of participants with adverse events. Severity of adverse events. Relationship between adverse event and drug concentration.
Measured: 2 months (treatment period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startDec 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chagas DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcelona Centre for International Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joaquim Gascón, PhD, Principal investigator, Barcelona Centre for International Health Research (CRESIB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755403
- Sponsor's protocol ID
- CINEBENZ
- Acronym
- CINEBENZ
- Status last verified
- May 2015
- First submitted
- 19 Dec 2012
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Aldasoro E, Posada E, Requena-Mendez A, Calvo-Cano A, Serret N, Casellas A, Sanz S, Soy D, Pinazo MJ, Gascon J. What to expect and when: benznidazole toxicity in chronic Chagas' disease treatment. J Antimicrob Chemother. 2018 Apr 1;73(4):1060-1067. doi: 10.1093/jac/dkx516.
PubMed 29351667Soy D, Aldasoro E, Guerrero L, Posada E, Serret N, Mejia T, Urbina JA, Gascon J. Population pharmacokinetics of benznidazole in adult patients with Chagas disease. Antimicrob Agents Chemother. 2015;59(6):3342-9. doi: 10.1128/AAC.05018-14. Epub 2015 Mar 30.
PubMed 25824212
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Pharmacokinetics in Benznidazole-treated Adults With Chronic Chagas Disease. Benznidazole Pharmacokinetics and Adverse Reactions Relationship.
- ClinicalTrials.gov ID
- NCT01755403
- Acronym / sponsor ID
- CINEBENZ / CINEBENZ
- Conditions
- Chagas Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Barcelona Centre for International Health ResearchUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Dec 2012 (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.
- study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benznidazole | Other | Drug: Benznidazole |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adult patients with Chronic Chagas Disease diagnosed by 2 different and positive serological tests.
- Patients with Chronic Chagas Disease who are going to start treatment with Benznidazole.
- Any gender.
- All the participants must agree to participate in the study and must sign the informed consent.
Key exclusion criteria (10 listed)
- Patients younger than 18.
- Patients with previous hypersensitivity to Benznidazole.
- Immunocompromised patients as AIDS, cancer, chemotherapy, longterm corticoids need, primary immunodeficiency, or any other.
- Hepatic dysfunction
- Renal dysfunction: serum creatinin higher than 3 mg/dl.
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 |
|---|---|---|
| Benznidazole | Drug | Benznidazole |
Primary outcome
Population pharmacokinetic parameters of Benznidazole
Time frame: 2 months (treatment period)
Population pharmacokinetic model development
1 secondary outcome
Adverse reactions
Time frame: 2 months (treatment period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2015.
- Derived from this study: PubMed 29351667Aldasoro E, Posada E, Requena-Mendez A, Calvo-Cano A, Serret N, Casellas A, Sanz S, Soy D, Pinazo MJ, Gascon J. What to expect and when: benznidazole toxicity in chronic Chagas' disease treatment. J Antimicrob Chemother. 2018 Apr 1;73(4):1060-1067. doi: 10.1093/jac/dkx516.
- Derived from this study: PubMed 25824212Soy D, Aldasoro E, Guerrero L, Posada E, Serret N, Mejia T, Urbina JA, Gascon J. Population pharmacokinetics of benznidazole in adult patients with Chagas disease. Antimicrob Agents Chemother. 2015;59(6):3342-9. doi: 10.1128/AAC.05018-14. Epub 2015 Mar 30.
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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.
Joaquim Gascón, PhD principal investigator
Barcelona Centre for International Health Research (CRESIB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benznidazole in people with Chagas Disease, run by Barcelona Centre for International Health Research at 1 site in Spain.
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 4 inclusion and 10 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Population pharmacokinetic parameters of Benznidazole (time frame: 2 months (treatment period)). 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 NCT01755403, which also lists 2 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 27 May 2015.