Testing Ingaron for treating pulmonary tuberculosis
A Multicenter Clinical Trial of Recombinant Human Interferon Gamma (Ingaron) in Pulmonary Tuberculosis
This study is testing if the drug Ingaron can safely help people in the hospital recover from respiratory tuberculosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 18 Years to 78 Years |
| Sex | All |
| Sponsor | SPP Pharmaclon Ltd. Industry-sponsored |
| Locations | 13 sites (Astrakhan, Astrakhan Oblast and 12 other locations) |
| Trial ID | NCT06118619 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness and safety of the drug Ingaron in patients hospitalized for respiratory tuberculosis. Participants will be monitored daily by their attending physician throughout their hospital stay. The study involves four control observations to assess the drug's impact at various intervals during the treatment process. Data will be collected after each observation to facilitate further evaluation of the drug's efficacy and safety.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 78 with a confirmed diagnosis of tuberculosis who are currently in the intensive phase of treatment.
Not a fit: Patients with serious conditions, pregnancy, or those who have had allergic reactions to Ingaron will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients suffering from pulmonary tuberculosis.
How similar studies have performed: While the use of interferon-gamma in tuberculosis treatment has been explored, this specific approach with Ingaron is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Astrakhan, Astrakhan Oblast and 12 other locations
- Astrakhan Oblast Tuberculosis Clinic — Astrakhan, Astrakhan Oblast, Russian Federation (Recruiting)
- Tuberculosis Clinic of the Chuvash Republic — Cheboksary, Chuvash Republic, Russian Federation (Recruiting)
- Leningrad Oblast Tuberculosis Clinic — Slantsy, Leningrad Oblast, Russian Federation (Completed)
- Leningrad Oblast Tuberculosis Hospital in Tikhvin — Tikhvin, Leningrad Oblast, Russian Federation (Completed)
- Clinical Phthisiopulmonological Medical Center — Perm, Perm Region, Russian Federation (Recruiting)
- Tuberculosis Clinic of the Republic of Bashkortostan — Ufa, Republic Of Bashkortostan, Russian Federation (Completed)
- Republican Tuberculosis Clinic — Kazan, Republic Of Tatarstan, Russian Federation (Recruiting)
- Ryazan Oblast Tuberculosis Clinic — Ryazan, Ryazan Oblast, Russian Federation (Completed)
- Sverdlovsk Oblast Clinical Medical Center of Phthisiopulmonology and Infectious Diseases — Yekaterinburg, Sverdlovsk Oblast, Russian Federation (Completed)
- Volgograd Oblast Tuberculosis Clinic — Volgograd, Volgograd Oblast, Russian Federation (Recruiting)
- N. S. Pokhvisneva Voronezh Oblast Clinical Tuberculosis Dispensary — Voronezh, Voronezh Oblast, Russian Federation (Completed)
- Yaroslavl regional tuberculosis clinic — Yaroslavl, Yaroslavl Region, Russian Federation (Completed)
- City tuberculosis clinic — Saint Petersburg, Russian Federation (Not_yet_recruiting)
Study contacts
- Study coordinator: Julia A Isakova, Master
- Email: isakova@pharmaclon.ru
- Phone: 8 107 905 535-33-11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.