A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis

November 7, 2023 updated by: SPP Pharmaclon Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Russian Federation
      • Saint Petersburg, Russian Federation, 196142
        • Not yet recruiting
        • City tuberculosis clinic
        • Contact:
    • Astrakhan Oblast
      • Astrakhan, Astrakhan Oblast, Russian Federation, 414004
        • Recruiting
        • Astrakhan Oblast Tuberculosis Clinic
        • Contact:
    • Chuvash Republic
      • Cheboksary, Chuvash Republic, Russian Federation, 428015
        • Recruiting
        • Tuberculosis Clinic of the Chuvash Republic
        • Contact:
    • Leningrad Oblast
      • Slantsy, Leningrad Oblast, Russian Federation, 188560
        • Completed
        • Leningrad Oblast Tuberculosis Clinic
      • Tikhvin, Leningrad Oblast, Russian Federation, 187550
        • Completed
        • Leningrad Oblast Tuberculosis Hospital in Tikhvin
    • Perm Region
      • Perm, Perm Region, Russian Federation, 614990
        • Recruiting
        • Clinical Phthisiopulmonological Medical Center
        • Contact:
    • Republic Of Bashkortostan
      • Ufa, Republic Of Bashkortostan, Russian Federation, 450080
        • Completed
        • Tuberculosis Clinic of the Republic of Bashkortostan
    • Republic Of Tatarstan
      • Kazan, Republic Of Tatarstan, Russian Federation, 420075
        • Recruiting
        • Republican Tuberculosis Clinic
        • Contact:
          • Il'gizjar F Mahmutov, Ph.D. med.
          • Phone Number: 8107 (843) 239-96-17
          • Email: ilfa1956@yandex.ru
    • Ryazan Oblast
      • Ryazan, Ryazan Oblast, Russian Federation, 390046
        • Completed
        • Ryazan Oblast Tuberculosis Clinic
    • Sverdlovsk Oblast
      • Yekaterinburg, Sverdlovsk Oblast, Russian Federation, 620142
        • Completed
        • Sverdlovsk Oblast Clinical Medical Center of Phthisiopulmonology and Infectious Diseases
    • Volgograd Oblast
      • Volgograd, Volgograd Oblast, Russian Federation, 400005
        • Recruiting
        • Volgograd Oblast Tuberculosis Clinic
        • Contact:
    • Voronezh Oblast
      • Voronezh, Voronezh Oblast, Russian Federation, 394070
        • Completed
        • N. S. Pokhvisneva Voronezh Oblast Clinical Tuberculosis Dispensary
    • Yaroslavl Region
      • Yaroslavl, Yaroslavl Region, Russian Federation, 152284
        • Completed
        • Yaroslavl regional tuberculosis clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Adult patients with tuberculosis

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No Intervention
only basic anti-tuberculosis therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of abacillated patients
Time Frame: 1 month
Proportion of abacillated patients according to fluorescence microscopy
1 month
Proportion of abacillated patients
Time Frame: 1 month
Proportion of abacillated patients according to culture data
1 month
Proportion of abacillated patients
Time Frame: 2 month
Proportion of abacillated patients according to fluorescence microscopy
2 month
Proportion of abacillated patients
Time Frame: 2 month
Proportion of abacillated patients according to culture data
2 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who died
Time Frame: 5 month
deaths associated with HIV infection and/or tuberculosis
5 month
Proportion of patients who required a change in therapy
Time Frame: 5 month
Proportion of patients who required a change in therapy due to ineffectiveness
5 month
Proportion of patients with adverse reactions
Time Frame: 5 month
Proportion of patients with adverse reactions, including those who required changes in therapy due to intolerance
5 month
Changes in the level of CD4 lymphocytes and HIV viral load in the blood
Time Frame: 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)
5 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SPP Pharmaclon Ltd.

Investigators

  • Study Director: Anatoly I Saulin, Master, SPP Pharmaclon Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

March 1, 2024

Study Registration Dates

First Submitted

November 1, 2023

First Submitted That Met QC Criteria

November 1, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Estimated)

November 9, 2023

Last Update Submitted That Met QC Criteria

November 7, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAM2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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