Clinical Trial

Clinical Trial of Mica

Active, Not Recruiting Phase 4

Summary

This study used a randomized, open, blank control design. A total of 6800 patients over 15 years old with latent mycobacterium tuberculosis infection who met the inclusion criteria but did not meet the exclusion criteria were randomly assigned to the experimental group and the blank control group in a 1:1 ratio, with 3400 patients in each group. The experimental group was alternately injected with 1 dose of microcard every two weeks (0-2-4-6-8-10 weeks) in the left and right hip muscle deep, with a total of 6 doses. The blank control group was not injected with drugs.

Protocol Amendment History 3 amendments

This ClinicalTrials.gov record has been amended 3 times since 2022-12-23; most recent amendment 2024-06-24.

Status change: Recruiting → Active, Not Recruiting 2024-06-24

Status change: Not Yet Recruiting → Recruiting 2023-06-07

Trial Details

NCT Number	NCT05680415
Lead Sponsor	Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Conditions	Latent Tuberculosis Infection
Enrollment	6,800 participants
Start Date	2023-04-19
Primary Completion	2026-09-30 (estimated)
Study Completion	2027-08-31 (estimated)
Updated on ClinicalTrials.gov	2024-06-25