Respiratory TuberculosisNCT06118619
A Multicenter Clinical Trial of Ingaron in Pulmonary Tuberculosis
An observational study of Respiratory Tuberculosis, run by SPP Pharmaclon Ltd. at 13 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Respiratory Tuberculosis
- What is being tested?
- Interferon-Gamma
- Type of treatment
- Injection or infusion
- How many people
- 350 participants
- Where
- 13 sitesRussia
- Study dates
- 1 Jun 2022to 1 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- Adult, Older adult
Study population: Adult patients with tuberculosis
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Russia13 sites, 6 recruiting
- Recruiting
Astrakhan Oblast Tuberculosis Clinic
Astrakhan, Astrakhan Oblast, 414004
Oksana A Ryzhkova, Ph.D. med, 8107 (908) 611-99-04, ryzhkova77@rambler.ru
- Recruiting
Tuberculosis Clinic of the Chuvash Republic
Cheboksary, Chuvashskaya Respublika, 428015
Mihail A Andreev, Master, 8107 (8352) 58-26-91, marina75misha69@mail.ru
- Recruiting
Republican Tuberculosis Clinic
Kazan', Tatarstan Republic, 420075
Il'gizjar F Mahmutov, Ph.D. med., 8107 (843) 239-96-17, ilfa1956@yandex.ru
- Recruiting
Clinical Phthisiopulmonological Medical Center
Perm, Perm Krai, 614990
Aleksandr A Shurygin, Dr. med., 8107 (342) 206-46-03, alex_shurygin@mail.ru
- Completed
Ryazan Oblast Tuberculosis Clinic
Ryazan, Ryazan Oblast, 390046
- Not yet recruiting
City tuberculosis clinic
Saint Petersburg, 196142
Aleksandr M Panteleev, Dr. med., 8107 (911) 735-63-13, alpanteleev@gmail.com
- Completed
Leningrad Oblast Tuberculosis Clinic
Slantsy, Leningradskaya Oblast', 188560
- Completed
Leningrad Oblast Tuberculosis Hospital in Tikhvin
Tikhvin, Leningradskaya Oblast', 187550
- Completed
Tuberculosis Clinic of the Republic of Bashkortostan
Ufa, Bashkortostan Republic, 450080
- Recruiting
Volgograd Oblast Tuberculosis Clinic
Volgograd, Volgograd Oblast, 400005
Svetlana G Gagarina, Ph.D. med., 8107 (937) 544-19-88, s.g.gagarina@mail.ru
- Completed
N. S. Pokhvisneva Voronezh Oblast Clinical Tuberculosis Dispensary
Voronezh, Voronezh Oblast, 394070
- Completed
Yaroslavl regional tuberculosis clinic
Yaroslavl, Yaroslavl Oblast, 152284
- Completed
Sverdlovsk Oblast Clinical Medical Center of Phthisiopulmonology and Infectious Diseases
Yekaterinburg, Sverdlovsk Oblast, 620142
About this study
Official title: 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.
Read the 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
- Respiratory Tuberculosis
- Being tested
- Interferon-Gamma
- Keywords
- Respiratory tuberculosis, interferon gamma
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon-GammaDrug
Also called Ingaron, Interferon gamma human recombinant
received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Interferon-Gamma | |
| No Intervention | only basic anti-tuberculosis therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of abacillated patients
Proportion of abacillated patients according to fluorescence microscopy
Measured: 1 month
Proportion of abacillated patients
Proportion of abacillated patients according to culture data
Measured: 1 month
Proportion of abacillated patients
Proportion of abacillated patients according to fluorescence microscopy
Measured: 2 month
Proportion of abacillated patients
Proportion of abacillated patients according to culture data
Measured: 2 month
Secondary outcomes (4)
Proportion of patients who died
deaths associated with HIV infection and/or tuberculosis
Measured: 5 month
Proportion of patients who required a change in therapy
Proportion of patients who required a change in therapy due to ineffectiveness
Measured: 5 month
Proportion of patients with adverse reactions
Proportion of patients with adverse reactions, including those who required changes in therapy due to intolerance
Measured: 5 month
Changes in the level of CD4 lymphocytes and HIV viral load in the blood
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)
Measured: 5 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Jun 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SPP Pharmaclon Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anatoly I Saulin, Master, Study director, SPP Pharmaclon Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118619
- Sponsor's protocol ID
- GAM2022
- Status last verified
- Nov 2023
- First submitted
- 1 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39871554
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Trial of Recombinant Human Interferon Gamma (Ingaron) in Pulmonary Tuberculosis
- ClinicalTrials.gov ID
- NCT06118619
- Acronym / sponsor ID
- GAM2022
- Conditions
- Respiratory Tuberculosis
- Keywords
- Respiratory tuberculosis, interferon gamma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- SPP Pharmaclon Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Drug: Interferon-GammaIngaron 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 |
| No Intervention | – | –only basic anti-tuberculosis therapy |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Adult patients with tuberculosis
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon-GammaAlso: Ingaron, Interferon gamma human recombinantreceived by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein | Drug | Experimental |
Primary outcome
Proportion of abacillated patients
Time frame: 1 month
Proportion of abacillated patients according to fluorescence microscopy
Proportion of abacillated patients
Time frame: 1 month
Proportion of abacillated patients according to culture data
Proportion of abacillated patients
Time frame: 2 month
Proportion of abacillated patients according to fluorescence microscopy
Proportion of abacillated patients
Time frame: 2 month
Proportion of abacillated patients according to culture data
4 secondary outcomes
Proportion of patients who died
Time frame: 5 month
Proportion of patients who required a change in therapy
Time frame: 5 month
Proportion of patients with adverse reactions
Time frame: 5 month
Changes in the level of CD4 lymphocytes and HIV viral load in the blood
Time frame: 5 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Derived from this study: PubMed 39871554Izosimova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anatoly I Saulin, Master study director
SPP Pharmaclon Ltd.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Tuberculosis, run by SPP Pharmaclon Ltd. at 13 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia A Isakova, Master (8 107 905 535-33-11, isakova@pharmaclon.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of abacillated patients (time frame: 1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118619, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.