CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 283 enrolled
Drug / intervention
Quantitative POC TSH Kit +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01921452
NCT01921452Phase 4Completed
CompareCT.gov

A Single-center Interventional Study to Verify Clinical Utility of the Quantitative and the Qualitative POC TSH Test Kits Compared With the Third Generation TSH Test Kit

Merck KGaA, Darmstadt, Germany·interventional·Posted Aug 13, 2013·Updated Nov 25, 2014

In Brief

A Phase 4 clinical trial evaluating Quantitative POC TSH Kit, Qualitative POC TSH Kit, and 1 other intervention for Hypothyroidism. Completed, enrolled 283 participants across 1 site.

Detailed Summary

This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at the same time.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypothyroidism
CountriesChina
Collaborators--

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 13, 2013
Enrollment StartOct 1, 2013
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 12.9 years ago

Interventions

Quantitative POC TSH Kitdevice

A drop (approximately 30 microliter \[mcL\]) of blood will be taken from subject's fingertip to test TSH quantitatively by using the quantitative POC TSH test kit according to the product specification on Day 1 to Day 5.

Qualitative POC TSH Kitdevice

A drop (approximately 30 mcL) of blood will be taken from subject's fingertip to test TSH qualitatively by using the qualitative POC TSH test kit according to the product specification on Day 1 to Day 5.

Third generation TSH Kitdevice

One milliliter (mL) of subject's venous blood will be taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit on Day 1 to Day 5.