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Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

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ClinicalTrials.gov Identifier: NCT02329730
Recruitment Status : Completed
First Posted : January 1, 2015
Results First Posted : April 9, 2015
Last Update Posted : April 9, 2015
Sponsor:
Collaborators:
Shanghai Public Health Clinical Center
Tianjin Haihe Hospital
Fourth Military Medical University
Proswell Medical Corporation
Information provided by (Responsible Party):
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Brief Summary:
Choose healthy subjects and patients with TB, distribute them into different dose groups according to the recombinant EC allergen dose from low to high average. Conducting clinical trials of TB-PPD or placebo as controlled arms intradermal injection. Do specific interferon gamma detection before the skin test,after the test 72h±2h and 144h±2h. Evaluate the safety of the recombinant EC allergy , and provide the appropriate dose range for phase IIb clinical trials.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative Biological: 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative Biological: 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative Biological: 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative Biological: 1μg/ml ESAT6-CFP10 and placebo Biological: 5μg/ml ESAT6-CFP10 and placebo Biological: 10μg/ml ESAT6-CFP10 and placebo Biological: 20μg/ml ESAT6-CFP10 and placebo Phase 2

Detailed Description:

First, 56 healthy subjects are distributed into different dose groups according to the recombinant EC allergen dose from low to high.Conducting clinical trials of TB-PPD as controlled arms intradermal injection.Do specific interferon gamma detection before the skin test,after the test 72h±2h and 144h±2h. The vital signs (breathing, heart rate, blood pressure and temperature), skin reaction at injection site (flush and induration) , local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events; The vital signs, blood routine, urine routine, liver and kidney function, electrocardiogram (before the skin test,after skin test 144h )are the main test items,Evaluate the safety of the recombinant EC allergy in the expansion of the healthy people , and provide the appropriate dose range for phase IIb clinical trials.

Second,56 patients of TB are distributed different dose groups according to the recombinant EC allergen dose from low to high. Conducting clinical trials of TB-PPD as controlled arms intradermal injection.Do specific interferon gamma detection before the skin test,after the test 72h±2h and 144h±2h. The vital signs (breathing, heart rate, blood pressure and temperature),skin reaction at injection site (flush and induration) , local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events; The vital signs, blood routine, urine routine, liver and kidney function, electrocardiogram (before the skin test,after skin test 144h )are the main test items,Evaluate the safety of the recombinant EC allergy in patients of TB,and provide the appropriate dose range for phase IIb clinical trials.

Third,32 patients of TB are distributed into different dose groups according to the recombinant EC allergen dose from low to high. Conducting clinical trials of placebo as controlled arms intradermal injection.Do specific interferon gamma detection before the skin test,after the test 72h±2h and 144h±2h. The vital signs (breathing, heart rate, blood pressure and temperature), skin reaction at injection site (flush and induration), local reactions (rash, pain, itching and skin mucous membrane) and a variety of adverse events; The vital signs, blood routine, urine routine, liver and kidney function, electrocardiogram (before the skin test,after skin test 144h )are the main test items,Evaluate the safety of the recombinant EC allergy in patients of TB on safety.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase IIa Clinical Study of Recombinant Mycobacterium Tuberculosis Antigen ESAT6-CFP10
Study Start Date : February 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: the healthy subjects
The healthy subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time , or 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time , or 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time , or 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time .Right arm inject ESAT6-CFP10 and left arm inject tuberculin purified protein derivative. Two drugs must be use in the same subjects.
Biological: 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 1μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.
Other Name: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 /TB-PPD

Biological: 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 5g/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.
Other Name: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10/TB-PPD

Biological: 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 10g/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.
Other Name: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 /TB-PPD

Biological: 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 20/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.
Other Name: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 /TB-PPD

Experimental: the first part of tuberculosis subjects
The first part kind of tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time , or 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time , or 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time , or 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative only one time .Right arm inject ESAT6-CFP10 and left arm inject tuberculin purified protein derivative. Two drugs must be use in the same subjects.
Biological: 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 1μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.
Other Name: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 /TB-PPD

Biological: 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 5g/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.
Other Name: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10/TB-PPD

Biological: 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 10g/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.
Other Name: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 /TB-PPD

Biological: 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative
Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 20/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.
Other Name: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 /TB-PPD

Experimental: the second part of tuberculosis subjects
The second part of tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and placebo only one time , or 5μg/ml ESAT6-CFP10 and placebo only one time , or 10μg/ml ESAT6-CFP10 and placebo only one time , or 20μg/ml ESAT6-CFP10 and placebo only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.
Biological: 1μg/ml ESAT6-CFP10 and placebo
Left arm intradermal injection of the placebo of 1μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 1μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.
Other Name: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

Biological: 5μg/ml ESAT6-CFP10 and placebo
Left arm intradermal injection of the placebo of 5μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 5μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.
Other Name: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

Biological: 10μg/ml ESAT6-CFP10 and placebo
Left arm intradermal injection of the placebo of 10μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 10μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.
Other Name: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10

Biological: 20μg/ml ESAT6-CFP10 and placebo
Left arm intradermal injection of the placebo of 20μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 20μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.
Other Name: Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10




Primary Outcome Measures :
  1. Number of Healthy Participants Negative for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10 [ Time Frame: 24 hours after intradermal injection ]

    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.

    The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10 .


  2. Number of Tuberculosis (TB) Participants Positive for Reaction at 24 Hours After Intradermal Injection With ESAT6-CFP10 [ Time Frame: 24 hours after intradermal injection ]
    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 24 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.

  3. Number of Healthy Participants Negative for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10 [ Time Frame: 48 hours after intradermal injection ]
    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.

  4. Number of Tuberculosis (TB) Participants Positive for Reaction at 48 Hours After Intradermal Injection With ESAT6-CFP10 [ Time Frame: 48 hours after intradermal injection ]
    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 48 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.

  5. Number of Healthy Participants Negative for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10 [ Time Frame: 72 hours after intradermal injection ]

    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.

    The percentage of negative(negative number/total number*100%) is the specificity of ESAT6-CFP10


  6. Number of Tuberculosis (TB) Participants Positive for Reaction at 72 Hours After Intradermal Injection With ESAT6-CFP10 [ Time Frame: 72 hours after intradermal injection ]
    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 72 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.

  7. Number of Healthy Participants Negative for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10 [ Time Frame: 96 hours after intradermal injection ]
    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in healthy participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the healthy participants' arm are positive reaction.

  8. Number of Tuberculosis (TB) Participants Positive for Reaction at 96 Hours After Intradermal Injection With ESAT6-CFP10 [ Time Frame: 96 hours after intradermal injection ]
    The investigators measure the longitudinal diameter and transverse diameter of induration and/or redness of ESAT6-CFP10 in TB participants at 96 hours after intradermal injection by vernier caliper . And at the same blisters and lymphangitis are the specificity of the positive reaction of ESAT6-CFP10 .So induration ,redness ,blisters and lymphangitis in the participants' arm are positive reaction.


Secondary Outcome Measures :
  1. the Number of Participants With Adverse Events [ Time Frame: before injection to 144 hours (plus or minus 2 hours) after injection ]

    evaluate specific time point of vital signs, skin test reaction, blood routine, urine routine, liver and kidney function, electrocardiogram and adverse events as the incidence of adverse events in the participants .

    Skin test reaction observation time: at the end of the skin test, skin test after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours; Vital signs evaluation time: 0 minutes before the subjects were intradermal injection, intradermal injection after 15 minutes, 1 hour, 4 hours, 24 hours, 48 hours, 72 hours, 96 hours, 144 hours.

    Blood routine, urine routine, liver and kidney function, electrocardiogram (ecg) evaluation time: skin test before and 144 h after injection; adverse events evaluation time: participants signed a written informed consent to finish all the follow-up.


  2. the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) Before Injection [ Time Frame: before injection and after signed ICF(informed consent forms) ]
    The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.

  3. the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) Before Injection [ Time Frame: 4 hours before injection and after signed ICF(informed consent forms) ]
    The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug. The percentage of positive(positive number/total number*100%) is the sensitivity of IFN-γ in TB Participants.

  4. the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10 [ Time Frame: 72 hours after injection ]
    The investigator draw 5ml venous blood for detection of IFN-γ four hours before injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.

  5. the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 72 Hours After Intradermal Injection With ESAT6-CFP10 [ Time Frame: 72 hours after injection ]
    The investigator draw 5ml venous blood for detection of IFN-γ 72 hours after injection with drug.The percentage of positive(positivenumber/total number*100%) is the sensitivity of IFN-γ in in TB participants.

  6. the Number of Healthy Participants Negative for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10 [ Time Frame: 144 hours after injection ]
    The investigator draw 5ml venous blood for detection of IFN-γ 144 hours after injection with drug.The percentage of negative(negative number/total number*100%) is the specificity of IFN-γ in healthy participants.

  7. the Number of Tuberculosis (TB) Participants Positive for IFN-γ(Gamma Interferon ) at 144 Hours After Intradermal Injection With ESAT6-CFP10 [ Time Frame: 144 hours after injection ]
    The investigator draw 5ml venous blood for detection of IFN-γ 144 hours before injection with drug.The percentage of positive(positive number/total number*100%) is the sensitivity of IFN-γ in in TB participants.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria of healthy subjects:

  1. 18 to 65 years old
  2. Consent and signed ICF(informed consent forms)
  3. Comply with follow-up
  4. No history or family history of TB(tuberculosis)
  5. Without the internal and external of pulmonary tuberculosis ; no symptoms of respiratory tract and other body parts for TB
  6. The examination such as X-ray chest radiograph, sputum bacteria confirmed non-tuberculosis (TB)
  7. No uncontrolled kinds of acute or chronic disease or acute infectious diseases or skin disease or skin allergies due to a variety of causes
  8. Physical condition : No obvious heart, liver, kidney, gastrointestinal tract, nervous system, mental disorder and metabolic abnormalities and other medical history from signed informed consent to the injection within four weeks prior to delivery ;by the comprehensive physical examination showed electrocardiogram, blood pressure, heart rate, breathing and laboratory tests, including blood, urine routine, liver, kidney and other various biochemical test all without exception or slightly unusual but does not affect our research
  9. Did not attend any other new drug clinical trials and not vaccinate prevention products and immunoglobulin for nearly 3 months
  10. Normal axillary temperature(quiet condition ≤37.0 ℃)
  11. No smoking, no alcohol and drinking caffeinated beverages during the study

Exclusion Criteria of Healthy volunteers:

  1. Has the following serious disease, such as advanced cancer, diabetes, chronic obstructive pulmonary disease (copd) in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc
  2. Have seizures, epilepsy, brain and nervous system symptoms or signs of history
  3. Has known or suspected (or risk possible) immune damaged or abnormal functional , accept glucocorticoid and immunosuppressants or immunopotentiator treatment, outside the gastrointestinal tract protein or blood products or plasma extraction in 3 months, immunodeficiency virus infection or related diseases
  4. Has acute febrile diseases and infectious diseases
  5. Participate in other new drug clinical trials
  6. Participated in any other new drug clinical trials in 3 months
  7. Allergic people who have histories of allergy to two or more drugs/food allergy and physical scars, are allergic to alcohol or drugs known to the group of points
  8. Women who are in pregnancy or lactation
  9. People with mental or physical disabilities
  10. Researchers consider that any conditions may affect the trial evaluation

Inclusion Criteria of TB (tuberculosis)subjects:

  1. Diagnosis TB according to the health of the People's Republic of China industry standard WS 288-2008 tuberculosis diagnostic criteria
  2. Aged 18 to 65 years old
  3. Consent and signed ICF to participate in this study
  4. Comply with the requirements of the clinical research plan for follow-up

Exclusion Criteria of TB volunteers:

  1. Have the following serious disease, such as advanced cancer, diabetes, chronic obstructive pulmonary disease (copd) in acute episodes, acute/ progressive liver disease or kidney disease, congestive heart failure, etc
  2. Have seizures, epilepsy, brain and nervous system symptoms or signs of history;
  3. Have known or suspected (or risk possible) immune damaged or abnormal functional , accept glucocorticoid and immunosuppressants or immunopotentiator treatment, outside the gastrointestinal tract protein or blood products or plasma extraction in 3 months, immunodeficiency virus infection or related diseases
  4. People in the pyrogenic stage with febrile diseases or infectious diseases (non tuberculosis)
  5. Participate in other new drug clinical trials
  6. Participated in any other new drug clinical trials in 3 months;
  7. Allergic people who have histories of allergy to two or more drugs/food allergy and physical scars, are allergic to alcohol or drugs known to the group of points;
  8. Women who are in pregnancy or lactation;
  9. People with mental or physical disabilities;
  10. Researchers consider that any conditions may affect the trial evaluation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329730


Sponsors and Collaborators
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Shanghai Public Health Clinical Center
Tianjin Haihe Hospital
Fourth Military Medical University
Proswell Medical Corporation
Investigators
Layout table for investigator information
Principal Investigator: Shuihua Lu, Bachelor Shanghai Public Health Clinical Center
Principal Investigator: Qi Wu, Master Tianjin Haihe Hospital

Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
ClinicalTrials.gov Identifier: NCT02329730     History of Changes
Other Study ID Numbers: LTao-EC IIa
First Posted: January 1, 2015    Key Record Dates
Results First Posted: April 9, 2015
Last Update Posted: April 9, 2015
Last Verified: March 2015
Keywords provided by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.:
diagnosis of Tuberculosis (TB)
ESAT6
CFP10
Phase IIa Clinical Trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections