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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
SPP Pharmaclon Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 7, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings