NCT00658294

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2008

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2012

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

5 years

First QC Date

April 8, 2008

Last Update Submit

October 16, 2017

Conditions

Interventions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with inoperable alveolar echinococchosis

You may qualify if:

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

You may not qualify if:

  • Positive PET-CT
  • Positive EmII-3-10 Serology
  • No compliance
  • Reduced life expectancy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (1)

  • Ammann RW, Stumpe KD, Grimm F, Deplazes P, Huber S, Bertogg K, Fischer DR, Mullhaupt 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.

MeSH Terms

Conditions

Alveolar echinococcosis

Study Officials

  • Beat Müllhaupt 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2008

First Posted

April 14, 2008

Study Start

January 1, 2008

Primary Completion

December 31, 2012

Study Completion

December 31, 2012

Last Updated

October 17, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations