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Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease (CINEBENZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01755403
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Barcelona Centre for International Health Research

Tracking Information
First Submitted Date  ICMJE December 19, 2012
First Posted Date  ICMJE December 24, 2012
Last Update Posted Date May 27, 2015
Study Start Date  ICMJE December 2012
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
Population pharmacokinetic parameters of Benznidazole [ Time Frame: 2 months (treatment period) ]
Population pharmacokinetic model development
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2012)
Adverse reactions [ Time Frame: 2 months (treatment period) ]
Number of participants with adverse events. Severity of adverse events. Relationship between adverse event and drug concentration.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Population Pharmacokinetics in Benznidazole-treated Adults With Chronic With Chagas Disease
Official Title  ICMJE Population Pharmacokinetics in Benznidazole-treated Adults With Chronic Chagas Disease. Benznidazole Pharmacokinetics and Adverse Reactions Relationship.
Brief Summary o study population pharmacokinetics in Benznidazole-treated adult patients with Chronic Chagas Disease to get information to optimize drug doses.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Chagas Disease
Intervention  ICMJE Drug: Benznidazole
Study Arms  ICMJE Benznidazole
Intervention: Drug: Benznidazole
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2014)
52
Original Estimated Enrollment  ICMJE
 (submitted: December 19, 2012)
50
Actual Study Completion Date  ICMJE November 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01755403
Other Study ID Numbers  ICMJE CINEBENZ
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Barcelona Centre for International Health Research
Study Sponsor  ICMJE Barcelona Centre for International Health Research
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joaquim Gascón, PhD Barcelona Centre for International Health Research (CRESIB)
PRS Account Barcelona Centre for International Health Research
Verification Date May 2015

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