Clinical trial NCT05378646: Efficiency and Safety of the Drug Ingaron (Interferon-gamma Human Recombinant) in the Treatment of Chronic Prostatitis
Official title: An Open Controlled Study of the Efficacy and Safety of Ingaron (Interferon-gamma Human Recombinant) in the Treatment of Chronic Prostatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Prostatitis
Keywords: interferon gamma
IFN-g
Chronic prostatitis
Lead sponsor: SPP Pharmaclon Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-18
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary purposes of the study are to evaluate the effectiveness of Ingaron in the complex therapy of chronic prostatitis, to assess the safety of using Ingaron in patients with chronic prostatitis.

Detailed description: Literature data and the results of preclinical studies of interferon-gamma, as well as the features of the immunopathogenesis of chronic prostatitis, show the expediency of studying the use of Ingaron in this pathology.

The study was conducted to compare the efficacy and safety of Ingaron in combination with standard therapy with its subcutaneous administration and standard therapy in patients with chronic prostatitis.

The study was planned to include 50 male patients aged at least 18 years with a confirmed diagnosis of chronic prostatitis.

In the course of the study, Ingaron was administered at a dose of 500,000 IU once a day, every other day. In addition to Ingaron, patients received antibiotic therapy, anti-inflammatory drugs, alpha-blockers (if necessary). Magnetic laser therapy and prostate massage were also provided.

The patients were divided into 2 groups: main and control.

Eligibility criteria: Inclusion Criteria:

1. Age at least 18 years old (at the time of inclusion).
2. Objectively confirmed diagnosis of chronic prostatitis at the time of inclusion in the study (more than 10 leukocytes / field of view in cytological examination of prostate secretion; more than 1x10\^5 CFU in bacteriological examination of prostate secretion (regardless of the nature of the inoculated microflora)).
3. Concomitant myco-, ureaplasma, gardnerella, chlamydial, urogenital viral infection is not excluded.
4. The volume of residual urine (Q max) is not more than 70 ml.
5. The maximum urination rate, according to urofluometry, is not less than 10 ml / sec.
6. Allowed previous therapy of chronic prostatitis, not less than 30 days after the end of the last course of treatment.
7. If there is a history of surgical treatment for benign prostatic hyperplasia, the time from the moment of surgery to inclusion in the study is at least 6 months.
8. Availability of written informed consent to participate in the clinical study.

Exclusion Criteria:

1. Positive test results for syphilis (Wasserman reaction), hepatitis (HbsAg, anti-HCV), HIV infection.
2. Known allergic reactions to interferons, or other significant allergic diseases.
3. A history of autoimmune disease.
4. The presence of external drains of the organs of the genitourinary system.
5. The presence of histologically proven prostate cancer.
6. A history of diabetes mellitus.
7. Any immunotropic therapy within the last 6 weeks prior to enrollment in the study.
8. Condition after organ transplantation, constant intake of immunosuppressive drugs.
9. Severe pathology from the cardiovascular system (uncontrolled arterial hypertension, unstable angina pectoris, congestive heart failure, cardiac arrhythmias), a history of myocardial infarction or cerebrovascular accident within the last 6 months.
10. Severe pathology of the liver (increased content of AST, ALT 2 times higher than the upper limit of the norm, the content of total bilirubin\> 2 mg / dl), kidney (creatinine content\> 1.5 mg / dl); signs of hepatic and / or renal failure.
11. Other serious (acute or chronic) pathological conditions, including mental illness, as well as abnormalities in laboratory parameters, which, in the opinion of the investigator, may increase the risk associated with participation in the study or affect the interpretation of the efficacy and safety data obtained in this research.
12. Alcohol and / or drug dependence.
13. Participation in other clinical trials in the last 3 months prior to inclusion.

Primary outcomes:
measure: Dynamics of the total score and improvement in the quality of life on the scale IPSS.
timeFrame: Day 13
measure: Immunohistochemical study of prostate secretion with assessment of cytological parameters.
timeFrame: Day 14
measure: Immunohistochemical study of prostate secretion with assessment of cytological parameters.
timeFrame: Day 14
measure: Evaluation of cytological parameters of prostate secretion.
timeFrame: Day 14
measure: Evaluation of cytological parameters of prostate secretion.
timeFrame: Day 14
measure: Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters.
timeFrame: Day 14
measure: Evaluation of cytological parameters of prostate secretion.
timeFrame: Day 90
measure: Immunohistochemical study of prostate secretion with assessment of cytological parameters.
timeFrame: Day 90
measure: Evaluation of cytological parameters of prostate secretion.
timeFrame: Day 90
measure: Evaluation of cytological parameters of prostate secretion.
timeFrame: Day 90
measure: Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters.
timeFrame: Day 90
measure: Evaluation of indicators of urination. Ultrasound of the prostate gland.
timeFrame: Day 90
measure: Evaluation of indicators of urination. Urofluometry.
timeFrame: Day 90
measure: Evaluation of indicators of urination. General urine analysis.
timeFrame: Day 90
measure: Evaluation of the inter-relapse period. Identification of an exacerbation of a chronic process.
timeFrame: Month 3
measure: Evaluation of the inter-relapse period. Identification of signs of a relapse of the disease.
timeFrame: Month 3
measure: Evaluation of the inter-relapse period. Identification of an exacerbation of a chronic process.
timeFrame: Month 6
measure: Evaluation of the inter-relapse period. Identification of signs of a relapse of the disease.
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SPP Pharmaclon Ltd.
name: Leonid Apanansky, Master
role: STUDY_DIRECTOR
References: