Efficiency and Safety of the Drug Ingaron (Interferon-gamma Human Recombinant) in the Treatment of Chronic Prostatitis (ING-HP-1)

An Open Controlled Study of the Efficacy and Safety of Ingaron (Interferon-gamma Human Recombinant) in the Treatment of Chronic Prostatitis

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.

Study Overview

• Status: Completed
• Conditions: Chronic Prostatitis
• Intervention / Treatment: Drug: Interferon gamma human recombinant (IFN-G)

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein; Other Names: Ingaron; Interferon gamma human recombinant
No Intervention: Control; Patients received standard treatment for chronic prostatitis. The period of active therapy was 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: SPP Pharmaclon Ltd.
• Investigators: Study Director: Leonid Apanansky, Master, SPP Pharmaclon Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2009
• Primary Completion (Actual): December 31, 2009
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: April 20, 2022
• First Submitted That Met QC Criteria: May 12, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): May 18, 2022
• Last Update Submitted That Met QC Criteria: May 12, 2022
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Chronic prostatitis; interferon gamma; IFN-g
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Prostatic Diseases; Chronic Disease; Prostatitis; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons; Interferon-gamma
• Other Study ID Numbers: ING-HP-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No