Chagas DiseasePhase 2STOP CHAGASNCT01377480
A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)
A Phase 2 study testing Posaconazole and Benznidazole in people with Chagas Disease, run by Merck Sharp & Dohme LLC.
Trial summary
This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg twice daily improves therapeutic response compared to placebo in participants with a diagnosis of asymptomatic chronic Chagas disease. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Chagas Disease
- What is being tested?
- Posaconazole and Benznidazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2011to 12 Jan 2015
- Phase
- Phase 2
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must have a positive serology result for Trypanosoma cruzi on any 2 of 3 of the following tests: indirect immunofluorescence, indirect hemagglutination, or enzyme-linked immunoabsorbent assay (ELISA)
- Must have a positive qualitative polymerase chain reaction (PCR) for Trypanosoma cruzi
- Must have a normal 12-lead electrocardiogram (ECG)
- Must have a normal 2-D echocardiogram
- Must have no evidence of ventricular tachycardia on 24-hour Holter monitoring
- Female participants of childbearing age must be using a medically accepted method of birth control before beginning study drug treatment and must agree to continue its use during the study, or must have been surgically sterilized
- Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline or within 72 hours before the start of study drug
Who cannot join
- Are breastfeeding, pregnant, or planning to become pregnant
- Body weight <60 kg
- Have an immunodeficiency or are immunosuppressed
- History of megacolon with obstipation or megaesophagus with severe swallowing impairment.
- Have previously received treatment with benznidazole or nifurtimox
- Known allergy/sensitivity to azoles
Show all 10Show fewer
- Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 2.5 times the upper limit of normal at Screening
- Has serum creatinine >2.5 mg/dL or 200 micromoles at Screening
- Has a history of severe alcohol abuse within two years from Screening
- Is taking any of the prohibited medication
About this study
Official title: Phase 2 Proof-of-Activity Study of Oral Posaconazole in the Treatment of Asymptomatic Chronic Chagas Disease (Phase 2, Protocol No. P05267)
This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg twice daily improves therapeutic response compared to placebo in participants with a diagnosis of asymptomatic chronic Chagas disease.
- Conditions
- Chagas Disease
- Being tested
- Posaconazole, Placebo for posaconazole, 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.
PosaconazoleDrug
Also called SCH 056592, MK-5592
POS 40 mg/mL oral suspension
Placebo for posaconazoleDrug
Placebo oral suspension
BenznidazoleDrug
BNZ 100 mg oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Posaconazole | Experimental | Posaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days Receives: Drug: Posaconazole |
| Placebo | Placebo comparator | Posaconazole placebo (10 mL) oral suspension twice daily for 60 days Receives: Drug: Placebo for posaconazole |
| Posaconazole + Benznidazole | Experimental | Posaconazole 400 mg (10 mL) oral suspension twice daily for 60 days and benznidazole (BNZ) 100 mg oral tablet twice daily (200-mg daily dose) for 60 days Receives: Drug: Posaconazole; Drug: Benznidazole |
| Benznidazole + Placebo | Active comparator | Posaconazole placebo (10 mL) oral suspension twice daily for 60 days and benznidazole 100 mg oral tablet twice daily (200-mg daily dose) for 60 days Receives: Drug: Placebo for posaconazole; Drug: Benznidazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction
Blood samples were collected for qualitative polymerase chain reaction (PCR) assay for Trypanosoma cruzi deoxyribonucleic acid (DNA). Successful response was defined as a negative qualitative PCR value at the Day 180 follow up visit.
Measured: Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2011 (estimated)
- Study start6 Jul 2011
- Primary completion22 Jul 2014
- Study completion12 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chagas DiseaseStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01377480
- Sponsor's protocol ID
- P05267
- Other IDs
- MK-5592-055
- Acronym
- STOP CHAGAS
- Status last verified
- Jul 2018
- First submitted
- 13 May 2011
- Last updated
- 27 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Morillo CA, Waskin H, Sosa-Estani S, Del Carmen Bangher M, Cuneo C, Milesi R, Mallagray M, Apt W, Beloscar J, Gascon J, Molina I, Echeverria LE, Colombo H, Perez-Molina JA, Wyss F, Meeks B, Bonilla LR, Gao P, Wei B, McCarthy M, Yusuf S; STOP-CHAGAS Investigators. Benznidazole and Posaconazole in Eliminating Parasites in Asymptomatic T. Cruzi Carriers: The STOP-CHAGAS Trial. J Am Coll Cardiol. 2017 Feb 28;69(8):939-947. doi: 10.1016/j.jacc.2016.12.023.
PubMed 28231946
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Proof-of-Activity Study of Oral Posaconazole in the Treatment of Asymptomatic Chronic Chagas Disease (Phase 2, Protocol No. P05267)
- ClinicalTrials.gov ID
- NCT01377480
- Acronym / sponsor ID
- STOP CHAGAS / P05267
- Conditions
- Chagas Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2011 (actual)
- Primary completion
- 22 Jul 2014 (actual)
- Study completion
- 12 Jan 2015 (actual)
- First posted
- 21 Jun 2011 (estimated)
- Results
- Posted 10 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg twice daily improves therapeutic response compared to placebo in participants with a diagnosis of asymptomatic chronic Chagas disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Posaconazole | Experimental | Drug: PosaconazolePosaconazole (POS) 400 mg (10 mL) oral suspension twice daily for 60 days |
| Placebo | Placebo comparator | Drug: Placebo for posaconazolePosaconazole placebo (10 mL) oral suspension twice daily for 60 days |
| Posaconazole + Benznidazole | Experimental | Drug: Posaconazole, Drug: BenznidazolePosaconazole 400 mg (10 mL) oral suspension twice daily for 60 days and benznidazole (BNZ) 100 mg oral tablet twice daily (200-mg daily dose) for 60 days |
| Benznidazole + Placebo | Active comparator | Drug: Placebo for posaconazole, Drug: BenznidazolePosaconazole placebo (10 mL) oral suspension twice daily for 60 days and benznidazole 100 mg oral tablet twice daily (200-mg daily dose) for 60 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Must have a positive serology result for Trypanosoma cruzi on any 2 of 3 of the following tests: indirect immunofluorescence, indirect hemagglutination, or enzyme-linked immunoabsorbent assay (ELISA)
- Must have a positive qualitative polymerase chain reaction (PCR) for Trypanosoma cruzi
- Must have a normal 12-lead electrocardiogram (ECG)
- Must have a normal 2-D echocardiogram
- Must have no evidence of ventricular tachycardia on 24-hour Holter monitoring
Key exclusion criteria (10 listed)
- Are breastfeeding, pregnant, or planning to become pregnant
- Body weight <60 kg
- Have an immunodeficiency or are immunosuppressed
- History of megacolon with obstipation or megaesophagus with severe swallowing impairment.
- Have previously received treatment with benznidazole or nifurtimox
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 |
|---|---|---|
| PosaconazoleAlso: SCH 056592, MK-5592POS 40 mg/mL oral suspension | Drug | Posaconazole, Posaconazole + Benznidazole |
| Placebo for posaconazolePlacebo oral suspension | Drug | Benznidazole + Placebo, Placebo |
| BenznidazoleBNZ 100 mg oral tablet | Drug | Benznidazole + Placebo, Posaconazole + Benznidazole |
Primary outcome
Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction
Time frame: Day 180
Blood samples were collected for qualitative polymerase chain reaction (PCR) assay for Trypanosoma cruzi deoxyribonucleic acid (DNA). Successful response was defined as a negative qualitative PCR value at the Day 180 follow up visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28231946Morillo CA, Waskin H, Sosa-Estani S, Del Carmen Bangher M, Cuneo C, Milesi R, Mallagray M, Apt W, Beloscar J, Gascon J, Molina I, Echeverria LE, Colombo H, Perez-Molina JA, Wyss F, Meeks B, Bonilla LR, Gao P, Wei B, McCarthy M, Yusuf S; STOP-CHAGAS Investigators. Benznidazole and Posaconazole in Eliminating Parasites in Asymptomatic T. Cruzi Carriers: The STOP-CHAGAS Trial. J Am Coll Cardiol. 2017 Feb 28;69(8):939-947. doi: 10.1016/j.jacc.2016.12.023.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Posaconazole and Benznidazole in people with Chagas Disease, run by Merck Sharp & Dohme LLC.
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 7 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 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 10 Aug 2015). 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?
Percentage of Participants With a Successful Response as Measured by Qualitative Polymerase Chain Reaction (time frame: Day 180). 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 NCT01377480, which also lists 1 linked publication.
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 Aug 2018.