Efficiency and Safety of the Drug Ingaron (Interferon-gamma Human Recombinant) in the Treatment of Chronic Prostatitis

NCT05378646 | Completed Phase 3

• 1 other identifier: ING-HP-1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Prostatitis

Keywords

interferon gamma; IFN-g; Chronic prostatitis

Outcome Measures

Primary Outcomes (18)

• Dynamics of the total score and improvement in the quality of life on the scale IPSS.

  The sum of points was assessed, as well as the symptom complex on the basis of the "IPSS" questionnaire - the international system for the total assessment of symptoms of prostate diseases in points (WHO, 1992). The severity of symptoms was assessed from 0 to 6 points. symptoms of prostate diseases in points (WHO, 1992). The severity of symptoms is rated from 0 to 6 points.

  Day 13

• Immunohistochemical study of prostate secretion with assessment of cytological parameters.

  Content of polymorphonuclear leukocytes in prostate secretion.

  Day 14

• Immunohistochemical study of prostate secretion with assessment of cytological parameters.

  The content of lymphocytes in prostate secretion.

  Day 14

• Evaluation of cytological parameters of prostate secretion.

  The number of lecithin grains.

  Day 14

• Evaluation of cytological parameters of prostate secretion.

  The number of epithelial cells.

  Day 14

• Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters.

  The effect of interferon-gamma on T-lymphocytes.

  Day 14

• Evaluation of cytological parameters of prostate secretion.

  The content of polymorphonuclear leukocytes in prostate secretion.

  Day 90

• Immunohistochemical study of prostate secretion with assessment of cytological parameters.

  The content of lymphocytes in prostate secretion.

  Day 90

• Evaluation of cytological parameters of prostate secretion.

  The number of lecithin grains.

  Day 90

• Evaluation of cytological parameters of prostate secretion.

  The number of epithelial cells.

  Day 90

• Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters.

  The effect of interferon-gamma on T-lymphocytes.

  Day 90

• Evaluation of indicators of urination. Ultrasound of the prostate gland.

  Ultrasound of the prostate gland.

  Day 90

• Evaluation of indicators of urination. Urofluometry.

  Urofluometry.

  Day 90

• Evaluation of indicators of urination. General urine analysis.

  General urine analysis.

  Day 90

• Evaluation of the inter-relapse period. Identification of an exacerbation of a chronic process.

  Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.

  Month 3

• Evaluation of the inter-relapse period. Identification of signs of a relapse of the disease.

  Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.

  Month 3

• Evaluation of the inter-relapse period. Identification of an exacerbation of a chronic process.

  Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.

  Month 6

• Evaluation of the inter-relapse period. Identification of signs of a relapse of the disease.

  Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.

  Month 6

Study Arms (2)

Experimental

EXPERIMENTAL

Patients received Ingaron 500,000 IU subcutaneously once a day, every other day. The course of treatment is 7 injections. The first injection was given on the first day of active therapy. Subsequent injections were given every other day. The period of active therapy was 14 days.

Drug: Interferon gamma human recombinant (IFN-G)

Control

NO INTERVENTION

Patients received standard treatment for chronic prostatitis. The period of active therapy was 14 days.

Interventions

Interferon gamma human recombinant (IFN-G) DRUG

received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein

Also known as: Ingaron, Interferon gamma human recombinant

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Concomitant myco-, ureaplasma, gardnerella, chlamydial, urogenital viral infection is not excluded.
• The volume of residual urine (Q max) is not more than 70 ml.
• The maximum urination rate, according to urofluometry, is not less than 10 ml / sec.
• Allowed previous therapy of chronic prostatitis, not less than 30 days after the end of the last course of treatment.
• Availability of written informed consent to participate in the clinical study.

You may not qualify if:

• Positive test results for syphilis (Wasserman reaction), hepatitis (HbsAg, anti-HCV), HIV infection.
• Known allergic reactions to interferons, or other significant allergic diseases.
• A history of autoimmune disease.
• The presence of external drains of the organs of the genitourinary system.
• The presence of histologically proven prostate cancer.
• A history of diabetes mellitus.
• Any immunotropic therapy within the last 6 weeks prior to enrollment in the study.
• Condition after organ transplantation, constant intake of immunosuppressive drugs.
• 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.
• 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.
• 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.
• Alcohol and / or drug dependence.

Sponsors & Collaborators

• SPP Pharmaclon Ltd.: lead

Study Officials

• Leonid Apanansky, Master

  SPP Pharmaclon Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 18, 2022
• Study Start: January 29, 2009
• Primary Completion: December 31, 2009
• Study Completion: February 1, 2010
• Last Updated: May 18, 2022

Record last verified: 2021-11