A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis

Sponsor

SPP Pharmaclon Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06118619

Collaborator

(none)

350

Enrollment

Locations

Anticipated Duration (Months)

26.9

Patients Per Site

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of testing: To confirm the effectiveness and safety of the drug Ingaron when used in patients hospitalized at the research center for various reasons.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Tuberculosis	Drug: Interferon-Gamma

Detailed Description

Monitoring of a patient in a hospital is carried out daily by the attending physician during the entire period of the patient's stay at the research center. When prescribing the drug Ingaron, the researcher must follow the instructions for use of the drug. As part of 4 control observations to assess effectiveness and safety:

1st on the 1st day of using the drug Ingaron and starting anti-tuberculosis therapy
2nd on the 30th - 31st day of therapy
3rd after 2 months of therapy
4th (final) after 3 months of follow-up After each of the 3 visits, the research doctor saves the data necessary for further evaluation.

Study Design

Study Type:

Observational

Anticipated Enrollment :

350 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

A Multicenter Clinical Trial of Recombinant Human Interferon Gamma (Ingaron) in Pulmonary Tuberculosis

Actual Study Start Date :

Jun 1, 2022

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental Ingaron 500,000 IU intramuscularly 1 time per day daily or every other day for 2 months (60 days) - a total of 30 or 60 injections + basic anti-tuberculosis therapy	Drug: Interferon-Gamma received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein Other Names: Ingaron Interferon gamma human recombinant
No Intervention only basic anti-tuberculosis therapy

Arm

Intervention/Treatment

Experimental

Ingaron 500,000 IU intramuscularly 1 time per day daily or every other day for 2 months (60 days) - a total of 30 or 60 injections + basic anti-tuberculosis therapy

Drug: Interferon-Gamma

received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein

Other Names:

Ingaron

Interferon gamma human recombinant

No Intervention

only basic anti-tuberculosis therapy

Outcome Measures

Primary Outcome Measures

Proportion of abacillated patients [1 month]
Proportion of abacillated patients according to fluorescence microscopy
Proportion of abacillated patients [1 month]
Proportion of abacillated patients according to culture data
Proportion of abacillated patients [2 month]
Proportion of abacillated patients according to fluorescence microscopy
Proportion of abacillated patients [2 month]
Proportion of abacillated patients according to culture data

Secondary Outcome Measures

Proportion of patients who died [5 month]
deaths associated with HIV infection and/or tuberculosis
Proportion of patients who required a change in therapy [5 month]
Proportion of patients who required a change in therapy due to ineffectiveness
Proportion of patients with adverse reactions [5 month]
Proportion of patients with adverse reactions, including those who required changes in therapy due to intolerance
Changes in the level of CD4 lymphocytes and HIV viral load in the blood [5 month]
Changes in the level of CD4 lymphocytes and HIV viral load in the blood (Proportion of patients with a CD4 level less than 350 cells/ml)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 78 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Age from 18 to 78 years inclusive
Bacterioscopically and/or molecularly genetically verified diagnosis of tuberculosis
Stay in the intensive phase of treatment
Consent to inpatient anti-tuberculosis therapy until the end of participation in clinical observation

Exclusion Criteria:

Serious condition
Pregnancy
Breastfeeding
Treatment with immunomodulatory drugs before inclusion in the observation program
Presence of medical history of an allergic reaction or individual intolerance to the drug Ingaron
Severe diseases of the liver, kidneys (creatinine more than 150 mmol/l)
Presence of contraindications to the administration of the drug Ingaron
Patients with HIV infection with a CD4 lymphocyte count less than 350 cells/ml

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Astrakhan Oblast Tuberculosis Clinic	Astrakhan	Astrakhan Oblast	Russian Federation	414004
2	Tuberculosis Clinic of the Chuvash Republic	Cheboksary	Chuvash Republic	Russian Federation	428015
3	Leningrad Oblast Tuberculosis Clinic	Slantsy	Leningrad Oblast	Russian Federation	188560
4	Leningrad Oblast Tuberculosis Hospital in Tikhvin	Tikhvin	Leningrad Oblast	Russian Federation	187550
5	Clinical Phthisiopulmonological Medical Center	Perm	Perm Region	Russian Federation	614990
6	Tuberculosis Clinic of the Republic of Bashkortostan	Ufa	Republic Of Bashkortostan	Russian Federation	450080
7	Republican Tuberculosis Clinic	Kazan	Republic Of Tatarstan	Russian Federation	420075
8	Ryazan Oblast Tuberculosis Clinic	Ryazan	Ryazan Oblast	Russian Federation	390046
9	Sverdlovsk Oblast Clinical Medical Center of Phthisiopulmonology and Infectious Diseases	Yekaterinburg	Sverdlovsk Oblast	Russian Federation	620142
10	Volgograd Oblast Tuberculosis Clinic	Volgograd	Volgograd Oblast	Russian Federation	400005
11	N. S. Pokhvisneva Voronezh Oblast Clinical Tuberculosis Dispensary	Voronezh	Voronezh Oblast	Russian Federation	394070
12	Yaroslavl regional tuberculosis clinic	Yaroslavl	Yaroslavl Region	Russian Federation	152284
13	City tuberculosis clinic	Saint Petersburg		Russian Federation	196142