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Phase I Clinical Protocol for Pre-evaluation of the Safety of BCG-PPD in Tuberculosis Patients
Sponsor: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Summary
A total of 60 TB patients aged 65 years and below who are randomly assigned to the experimental group and the control group. The experimental group is injected with BCG-PPD test drug once, and the control group is injected with BCG-PPD control drug once.Subjects undergoing physical examination, vital signs, blood routine, urine routine, blood biochemistry, electrocardiogram, chest X-ray, tuberculosis culture, tuberculosis smear, HIV antibody test and blood pregnancy(only women of childbearing age) during the screening period.Vital signs were checked before skin test, the injection site is photographed at 0min after skin test, and vital signs are checked at 30min after skin test.Vital signs examination, injection site photography and reaction measurement are performed 48h and 72h after skin test.Physical examination, vital signs, routine blood test, routine urine test, biochemical test, electrocardiogram and blood pregnancy test are performed again 7 days after skin test to evaluate the safety of BCG-PPD.
Official title: Randomized, Blinded, Single-arm Intradermal Injection, Control of Similar Products on the Market, the Safety Pre-evaluation Phase I Clinical Trial of BCG-PPD in Tuberculosis Patients
Key Details
Gender
All
Age Range
Any - 65 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2021-07-02
Completion Date
2025-12
Last Updated
2024-12-11
Healthy Volunteers
No
Conditions
Interventions
BCG-PPD
BCG-PPD was used for skin test in 30 TB patients, and BCG-PPD was marketed in other 30 TB patients (as control)
Locations (1)
The Third People's Hospital Of Shenzhen
Shenzhen, Guangdong, China