Status:
COMPLETED
Phase II Clinical Clical of the Pure Protein Derivatives of BCG
Lead Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Collaborating Sponsors:
Shenzhen Third People's Hospital
Conditions:
Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This phase II clinical trial used randomized, double-blind, double-arm intradermal injection, and the same marketed products, selected 30 pulmonary tuberculosis patients aged 18-65 years who met the i...
Detailed Description
Prior to the commencement of the study, the Investigator/his authorized officer will contact the subject and/or guardian to enroll the candidate subjects and invite them to participate in the study.Su...
Eligibility Criteria
Inclusion
- The subject shall be judged as a confirmed tuberculosis patient by a clinician according to Section 5.3.1-5.3.6 of the Health Industry Standards of the People's Republic of China (WS288-2017) (Annex I).(The sampling time can be accepted for the laboratory examination is the examination results of the hospital within 30 days before the skin test);
- Age 18\~65, male or female;
- I agree to participate in this trial and sign the informed consent form;
- I am able to follow the follow-up requirements of the clinical trial protocol for follow-up
Exclusion
- People suffering from acute infectious diseases (such as measles, whooping cough, influenza, pneumonia, etc.), acute ocular conjunctivitis, acute otitis media, extensive skin diseases and allergic constitution;
- Having serious diseases not considered suitable for enrollment by the investigator, such as: advanced tumor, acute onset of chronic obstructive pulmonary disease, acute or progressive liver disease or kidney disease, congestive heart failure, etc.;
- Those treated with immunosuppressants or immune enhancer, or those receiving glucocorticoids, immunoglobulin preparations other than the gastrointestinal tract, or blood products or plasma extracts within 1 month;
- Those who are participating in other new drug clinical trials or have participated in any other new drug clinical trials within 3 months before the clinical trial;
- Women during pregnancy or lactation;
- Patients with mental illness onset period;
- PPD or similar products within 3 months;
- The investigator considered poor compliance, past history, physical examination or laboratory findings.
Key Trial Info
Start Date :
July 26 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06975774
Start Date
July 26 2023
End Date
January 15 2024
Last Update
May 16 2025
Active Locations (1)
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1
The Third People's Hospital Of Shenzhen
Shenzhen, Guangdong, China