A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267) (STOP CHAGAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01377480
First received: May 13, 2011
Last updated: February 17, 2014
Last verified: February 2014

May 13, 2011
February 17, 2014
July 2011
July 2014   (final data collection date for primary outcome measure)
Number of participants with a reduction of parasitemia as measured by qualitative polymerase chain reaction (PCR) [ Time Frame: Day 180 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01377480 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)
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 (POS) to placebo for the treatment of asymptomatic Chagas disease.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Chagas Disease
  • Drug: Posaconazole
    10 mL orally twice daily for 60 days
    Other Name: SCH 056592
  • Drug: Placebo for posaconazole
    10 mL orally twice daily for 60 days
  • Drug: Benznidazole
    200 mg orally twice daily for 60 days
  • Experimental: Posaconazole
    Intervention: Drug: Posaconazole
  • Placebo Comparator: Posaconazole Placebo
    Intervention: Drug: Placebo for posaconazole
  • Experimental: Posaconazole + Benznidazole
    Interventions:
    • Drug: Posaconazole
    • Drug: Benznidazole
  • Active Comparator: Posaconazole Placebo+ Benznidazole
    Interventions:
    • Drug: Placebo for posaconazole
    • Drug: Benznidazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
160
January 2015
July 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

- 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

Exclusion Criteria:

  • 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
  • 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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01377480
P05267
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP