A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis

NCT06118619 | Unknown

• 1 other identifier: GAM2022
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 13

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.

Conditions

Respiratory Tuberculosis

Keywords

Respiratory tuberculosis; interferon gamma

Outcome Measures

Primary Outcomes (4)

• Proportion of abacillated patients

  Proportion of abacillated patients according to fluorescence microscopy

  1 month

• Proportion of abacillated patients

  Proportion of abacillated patients according to culture data

  1 month

• Proportion of abacillated patients

  Proportion of abacillated patients according to fluorescence microscopy

  2 month

• Proportion of abacillated patients

  Proportion of abacillated patients according to culture data

  2 month

Secondary Outcomes (4)

• Proportion of patients who died

  5 month

• Proportion of patients who required a change in therapy

  5 month

• Proportion of patients with adverse reactions

  5 month

• Changes in the level of CD4 lymphocytes and HIV viral load in the blood

  5 month

Study Arms (2)

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

No Intervention

only basic anti-tuberculosis therapy

Interventions

Interferon-Gamma DRUG

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

Also known as: Ingaron, Interferon gamma human recombinant

Experimental

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with tuberculosis

You may qualify if:

• 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

You may not qualify if:

• Serious condition
• Pregnancy
• Breastfeeding
• 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

Sponsors & Collaborators

• SPP Pharmaclon Ltd.: lead

Study Sites (13)

Astrakhan Oblast Tuberculosis Clinic

Astrakhan, Astrakhan Oblast, 414004, Russia

RECRUITING

Tuberculosis Clinic of the Republic of Bashkortostan

Ufa, Bashkortostan Republic, 450080, Russia

COMPLETED

Tuberculosis Clinic of the Chuvash Republic

Cheboksary, Chuvashskaya Respublika, 428015, Russia

RECRUITING

Leningrad Oblast Tuberculosis Clinic

Slantsy, Leningradskaya Oblast', 188560, Russia

COMPLETED

Leningrad Oblast Tuberculosis Hospital in Tikhvin

Tikhvin, Leningradskaya Oblast', 187550, Russia

COMPLETED

Clinical Phthisiopulmonological Medical Center

Perm, Perm Krai, 614990, Russia

RECRUITING

Ryazan Oblast Tuberculosis Clinic

Ryazan, Ryazan Oblast, 390046, Russia

COMPLETED

Sverdlovsk Oblast Clinical Medical Center of Phthisiopulmonology and Infectious Diseases

Yekaterinburg, Sverdlovsk Oblast, 620142, Russia

COMPLETED

Republican Tuberculosis Clinic

Kazan', Tatarstan Republic, 420075, Russia

RECRUITING

Volgograd Oblast Tuberculosis Clinic

Volgograd, Volgograd Oblast, 400005, Russia

RECRUITING

N. S. Pokhvisneva Voronezh Oblast Clinical Tuberculosis Dispensary

Voronezh, Voronezh Oblast, 394070, Russia

COMPLETED

Yaroslavl regional tuberculosis clinic

Yaroslavl, Yaroslavl Oblast, 152284, Russia

COMPLETED

City tuberculosis clinic

Saint Petersburg, 196142, Russia

NOT YET RECRUITING

Related Publications (1)

• Izosimova VE, Barmina NA, Zharikova MP, Alekseyev OY, Ryzhkova OA, Sayfulin MH, Popova NA, Andreyev MA, Gagarina SG, Rysdauletova RM, Kamaeva NG, Samoylova AG, Romanova MI. A Clinical Multicenter Trial of Recombinant Human Interferon Gamma in Tuberculosis (GAM2022): Experience with the Use of Human Recombinant Interferon Gamma in TB Practice. Infect Disord Drug Targets. 2025;25(6):e18715265329137. doi: 10.2174/0118715265329137250102103507.

  PMID: 39871554 DERIVED

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Interferon-gamma

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Interferons; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Macrophage-Activating Factors; Lymphokines; Proteins; Biological Factors

Study Officials

• Anatoly I Saulin, Master

  SPP Pharmaclon Ltd.

  STUDY DIRECTOR

Central Study Contacts

Julia A Isakova, Master

CONTACT

8 107 905 535-33-11; isakova@pharmaclon.ru

Polina I Pekhtereva, Master

CONTACT

8 107 909 675-96-43; pekhtereva@pharmaclon.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2023
• First Posted: November 7, 2023
• Study Start: June 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: March 1, 2024
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (13)