A Phase 3 interventional study of Interferon gamma human recombinant (IFN-G) in Chronic Prostatitis, sponsored by SPP Pharmaclon Ltd.. Completed. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by SPP Pharmaclon Ltd. · Phase 3, Interventional, and Treatment
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.
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.
88 studies on the registry are indexed under Prostatitis; 11 are open to participants now.
This study's enrollment of 30 is below the median of 60 across 73 interventional studies indexed under Prostatitis.
Browse Prostatitis studies →SPP Pharmaclon Ltd. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Patients received standard treatment for chronic prostatitis. The period of active therapy was 14 days.
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
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.
Time frame: Day 13
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
Content of polymorphonuclear leukocytes in prostate secretion.
Time frame: Day 14
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
The content of lymphocytes in prostate secretion.
Time frame: Day 14
Evaluation of cytological parameters of prostate secretion.
The number of lecithin grains.
Time frame: Day 14
Evaluation of cytological parameters of prostate secretion.
The number of epithelial cells.
Time frame: 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.
Time frame: Day 14
Evaluation of cytological parameters of prostate secretion.
The content of polymorphonuclear leukocytes in prostate secretion.
Time frame: Day 90
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
The content of lymphocytes in prostate secretion.
Time frame: Day 90
Evaluation of cytological parameters of prostate secretion.
The number of lecithin grains.
Time frame: Day 90
Evaluation of cytological parameters of prostate secretion.
The number of epithelial cells.
Time frame: 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.
Time frame: Day 90
Evaluation of indicators of urination. Ultrasound of the prostate gland.
Ultrasound of the prostate gland.
Time frame: Day 90
Evaluation of indicators of urination. Urofluometry.
Urofluometry.
Time frame: Day 90
Evaluation of indicators of urination. General urine analysis.
General urine analysis.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 6
No study locations are listed for this record.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Interferon Gamma
SPP Pharmaclon Ltd.