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Analysis of the Potentially Parasitocidal Effect of a Long Term Chemotherapy With Benzimidazoles

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: NCT00658294
Recruitment Status : Completed
First Posted : April 14, 2008
Last Update Posted : October 17, 2017
Sponsor:
Information provided by (Responsible Party):
University of Zurich

Tracking Information
First Submitted Date April 8, 2008
First Posted Date April 14, 2008
Last Update Posted Date October 17, 2017
Actual Study Start Date January 2008
Actual Primary Completion Date December 31, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Analysis of the Potentially Parasitocidal Effect of a Long Term Chemotherapy With Benzimidazoles
Official Title Analysis of the Potentially Parasitocidal Effect of a Long Term Chemotherapy With Benzimidazoles in Patients With Inoperable Alveolar Echinococcosis Using PET-CT and EmII/3-10 Serology
Brief Summary

The aim of this study is to evaluate PET-CT and EmII/3-10 serology as potential markers to assess the parasitocidal effect of benzimidazoles

  • Trial with medicinal product
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with inoperable alveolar echinococchosis
Condition Alveolar Echinococcosis
Intervention Other: Stop treatment
Study Groups/Cohorts Not Provided
Publications * Ammann RW, Stumpe KD, Grimm F, Deplazes P, Huber S, Bertogg K, Fischer DR, Müllhaupt B. Outcome after Discontinuing Long-Term Benzimidazole Treatment in 11 Patients with Non-resectable Alveolar Echinococcosis with Negative FDG-PET/CT and Anti-EmII/3-10 Serology. PLoS Negl Trop Dis. 2015 Sep 21;9(9):e0003964. doi: 10.1371/journal.pntd.0003964. eCollection 2015.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 16, 2017)
34
Original Estimated Enrollment
 (submitted: April 11, 2008)
30
Actual Study Completion Date December 31, 2012
Actual Primary Completion Date December 31, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

  • Patients with inoperable alveolar echinococcosis
  • With negative PET-CT
  • EmII/3-10 serology under long-term chemotherapy with benzimidazoles

Exclusion criteria:

  • Positive PET-CT
  • Positive EmII-3-10 Serology
  • No compliance
  • Reduced life expectancy
  • Pregnancy
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number NCT00658294
Other Study ID Numbers EK-1351
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Zurich
Study Sponsor University of Zurich
Collaborators Not Provided
Investigators
Principal Investigator: Beat Müllhaupt 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
PRS Account University of Zurich
Verification Date October 2017