Clinical Trials Directory

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UnknownNCT06118619

A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis

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

Status
Unknown
Phase
Study type
Observational
Enrollment
350 (estimated)
Sponsor
SPP Pharmaclon Ltd. · Industry
Sex
All
Age
18 Years – 78 Years
Healthy volunteers

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.

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.

Conditions

Interventions

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

Timeline

Start date
2022-06-01
Primary completion
2023-12-31
Completion
2024-03-01
First posted
2023-11-07
Last updated
2023-11-09

Locations

13 sites across 1 country: Russia

Source: ClinicalTrials.gov record NCT06118619. Inclusion in this directory is not an endorsement.