Back to resultsEfficiency and Safety of the Drug Ingaron (Interferon-gamma Human Recombinant) in the Treatment of Chronic Prostatitis (ING-HP-1)
Primary Purpose
Chronic Prostatitis
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Interferon gamma human recombinant (IFN-G)
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Prostatitis focused on measuring interferon gamma, IFN-g, Chronic prostatitis
Eligibility Criteria
Inclusion Criteria:
- Age at least 18 years old (at the time of inclusion).
- 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)).
- 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.
- 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.
- Availability of written informed consent to participate in the clinical study.
Exclusion Criteria:
- 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.
- Participation in other clinical trials in the last 3 months prior to inclusion.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental
Control
Arm Description
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.
Patients received standard treatment for chronic prostatitis. The period of active therapy was 14 days.
Outcomes
Primary Outcome Measures
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.
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
Content of polymorphonuclear leukocytes in prostate secretion.
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
The content of lymphocytes in prostate secretion.
Evaluation of cytological parameters of prostate secretion.
The number of lecithin grains.
Evaluation of cytological parameters of prostate secretion.
The number of epithelial cells.
Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters.
The effect of interferon-gamma on T-lymphocytes.
Evaluation of cytological parameters of prostate secretion.
The content of polymorphonuclear leukocytes in prostate secretion.
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
The content of lymphocytes in prostate secretion.
Evaluation of cytological parameters of prostate secretion.
The number of lecithin grains.
Evaluation of cytological parameters of prostate secretion.
The number of epithelial cells.
Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters.
The effect of interferon-gamma on T-lymphocytes.
Evaluation of indicators of urination. Ultrasound of the prostate gland.
Ultrasound of the prostate gland.
Evaluation of indicators of urination. Urofluometry.
Urofluometry.
Evaluation of indicators of urination. General urine analysis.
General urine analysis.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05378646
Brief Title
Efficiency and Safety of the Drug Ingaron (Interferon-gamma Human Recombinant) in the Treatment of Chronic Prostatitis
Acronym
ING-HP-1
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
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 29, 2009 (Actual)
Primary Completion Date
December 31, 2009 (Actual)
Study Completion Date
February 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SPP Pharmaclon Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis
Keywords
interferon gamma, IFN-g, Chronic prostatitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients received standard treatment for chronic prostatitis. The period of active therapy was 14 days.
Intervention Type
Drug
Intervention Name(s)
Interferon gamma human recombinant (IFN-G)
Other Intervention Name(s)
Ingaron, Interferon gamma human recombinant
Intervention Description
received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein
Primary Outcome Measure Information:
Title
Dynamics of the total score and improvement in the quality of life on the scale IPSS.
Description
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.
Time Frame
Day 13
Title
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
Description
Content of polymorphonuclear leukocytes in prostate secretion.
Time Frame
Day 14
Title
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
Description
The content of lymphocytes in prostate secretion.
Time Frame
Day 14
Title
Evaluation of cytological parameters of prostate secretion.
Description
The number of lecithin grains.
Time Frame
Day 14
Title
Evaluation of cytological parameters of prostate secretion.
Description
The number of epithelial cells.
Time Frame
Day 14
Title
Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters.
Description
The effect of interferon-gamma on T-lymphocytes.
Time Frame
Day 14
Title
Evaluation of cytological parameters of prostate secretion.
Description
The content of polymorphonuclear leukocytes in prostate secretion.
Time Frame
Day 90
Title
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
Description
The content of lymphocytes in prostate secretion.
Time Frame
Day 90
Title
Evaluation of cytological parameters of prostate secretion.
Description
The number of lecithin grains.
Time Frame
Day 90
Title
Evaluation of cytological parameters of prostate secretion.
Description
The number of epithelial cells.
Time Frame
Day 90
Title
Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters.
Description
The effect of interferon-gamma on T-lymphocytes.
Time Frame
Day 90
Title
Evaluation of indicators of urination. Ultrasound of the prostate gland.
Description
Ultrasound of the prostate gland.
Time Frame
Day 90
Title
Evaluation of indicators of urination. Urofluometry.
Description
Urofluometry.
Time Frame
Day 90
Title
Evaluation of indicators of urination. General urine analysis.
Description
General urine analysis.
Time Frame
Day 90
Title
Evaluation of the inter-relapse period. Identification of an exacerbation of a chronic process.
Description
Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.
Time Frame
Month 3
Title
Evaluation of the inter-relapse period. Identification of signs of a relapse of the disease.
Description
Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.
Time Frame
Month 3
Title
Evaluation of the inter-relapse period. Identification of an exacerbation of a chronic process.
Description
Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.
Time Frame
Month 6
Title
Evaluation of the inter-relapse period. Identification of signs of a relapse of the disease.
Description
Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.
Time Frame
Month 6
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age at least 18 years old (at the time of inclusion).
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)).
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.
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.
Availability of written informed consent to participate in the clinical study.
Exclusion Criteria:
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.
Participation in other clinical trials in the last 3 months prior to inclusion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonid Apanansky, Master
Organizational Affiliation
SPP Pharmaclon Ltd.
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficiency and Safety of the Drug Ingaron (Interferon-gamma Human Recombinant) in the Treatment of Chronic Prostatitis
We'll reach out to this number within 24 hrs