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You can access this
clinical trial
if you have
Tuberculosis Diagnosis
and you are
under 17
years old
3
This is a trial in the final phase before the treatment is released on the market.
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The purpose

In this clinical research,48 cases TB (Tuberculosis patients) participants and 48 cases non-TB participants with lung disease who all meet the standard are divided into different groups through a randomized and blind method. Every subject inject intradermally ESAT6-CFP10 and TB-PPD (tuberculin purified protein derivative) in different arms of the same person by blind method. Specific gama-interferon (γ-IFN) detection is needed before the injection.Measure the induration and (or) redness of longitudinal diameter size and transverse diameter vernier caliper by vernier caliper after injection 24h, 48h and 72h. At the same time, we observe all kind of adverse events in order to assess the safety of drug.

Provided treatments

  • Biological: ESAT6-CFP10 in left arm and TB-PPD in right arm
  • Biological: ESAT6-CFP10 in right arm and TB-PPD in left arm
Tris trial is registered with FDA with number: NCT03027154. The sponsor of the trial is Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. and it is looking for 96 volunteers for the current phase.
Official trial title:
For Tuberculosis (TB) Clinical Auxiliary Diagnosis of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 Dose Certain Phase III Clinical Research in Children Under the Age of 18 Years Old