Chronic ProstatitisPhase 3ING-HP-1NCT05378646

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

A Phase 3 study testing Interferon gamma human recombinant (IFN-G) in people with Chronic Prostatitis, run by SPP Pharmaclon Ltd..

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Chronic Prostatitis
What is being tested?: Interferon gamma human recombinant (IFN-G)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 29 Jan 2009to Feb 2010
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

About this study

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

Read the 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.

Conditions: Chronic Prostatitis
Being tested: Interferon gamma human recombinant (IFN-G)
Keywords: interferon gamma, IFN-g, Chronic prostatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Interferon gamma human recombinant (IFN-G)Drug
Also called Ingaron, Interferon gamma human recombinant
received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein

Study groups in NCT05378646
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Day 13
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
Content of polymorphonuclear leukocytes in prostate secretion.
Measured: Day 14
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
The content of lymphocytes in prostate secretion.
Measured: Day 14
Evaluation of cytological parameters of prostate secretion.
The number of lecithin grains.
Measured: Day 14
Evaluation of cytological parameters of prostate secretion.
The number of epithelial cells.
Measured: 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.
Measured: Day 14
Evaluation of cytological parameters of prostate secretion.
The content of polymorphonuclear leukocytes in prostate secretion.
Measured: Day 90
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
The content of lymphocytes in prostate secretion.
Measured: Day 90
Evaluation of cytological parameters of prostate secretion.
The number of lecithin grains.
Measured: Day 90
Evaluation of cytological parameters of prostate secretion.
The number of epithelial cells.
Measured: 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.
Measured: Day 90
Evaluation of indicators of urination. Ultrasound of the prostate gland.
Ultrasound of the prostate gland.
Measured: Day 90
Evaluation of indicators of urination. Urofluometry.
Urofluometry.
Measured: Day 90
Evaluation of indicators of urination. General urine analysis.
General urine analysis.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jan 2009Feb 2010

First posted18 May 2022
Study start29 Jan 2009
Primary completion31 Dec 2009
Study completionFeb 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic ProstatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05378646
Sponsor's protocol ID: ING-HP-1
Acronym: ING-HP-1
Status last verified: Nov 2021
First submitted: 20 Apr 2022
Last updated: 18 May 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Controlled Study of the Efficacy and Safety of Ingaron (Interferon-gamma Human Recombinant) in the Treatment of Chronic Prostatitis
ClinicalTrials.gov ID: NCT05378646
Acronym / sponsor ID: ING-HP-1 / ING-HP-1
Conditions: Chronic Prostatitis
Keywords: interferon gamma, IFN-g, Chronic prostatitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: SPP Pharmaclon Ltd.Industry (pharma, biotech, devices)
Study start: 29 Jan 2009 (actual)
Primary completion: 31 Dec 2009 (actual)
Study completion: Feb 2010 (actual)
First posted: 18 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Experimental	Experimental	Drug: Interferon gamma human recombinant (IFN-G)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.
Control	No intervention	–Patients received standard treatment for chronic prostatitis. The period of active therapy was 14 days.

Who may qualify

Ages: 18 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Interferon gamma human recombinant (IFN-G)Also: Ingaron, Interferon gamma human recombinantreceived by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein	Drug	Experimental

Primary outcome

Dynamics of the total score and improvement in the quality of life on the scale IPSS.
Time frame: Day 13
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.
Time frame: Day 14
Content of polymorphonuclear leukocytes in prostate secretion.
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
Time frame: Day 14
The content of lymphocytes in prostate secretion.
Evaluation of cytological parameters of prostate secretion.
Time frame: Day 14
The number of lecithin grains.
Evaluation of cytological parameters of prostate secretion.
Time frame: Day 14
The number of epithelial cells.
Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters.
Time frame: Day 14
The effect of interferon-gamma on T-lymphocytes.
Evaluation of cytological parameters of prostate secretion.
Time frame: Day 90
The content of polymorphonuclear leukocytes in prostate secretion.
Immunohistochemical study of prostate secretion with assessment of cytological parameters.
Time frame: Day 90
The content of lymphocytes in prostate secretion.
Evaluation of cytological parameters of prostate secretion.
Time frame: Day 90
The number of lecithin grains.
Evaluation of cytological parameters of prostate secretion.
Time frame: Day 90
The number of epithelial cells.
Microscopy of prostate secretion and immunohistochemical study of prostate secretion with assessment of cytological parameters.
Time frame: Day 90
The effect of interferon-gamma on T-lymphocytes.
Evaluation of indicators of urination. Ultrasound of the prostate gland.
Time frame: Day 90
Ultrasound of the prostate gland.
Evaluation of indicators of urination. Urofluometry.
Time frame: Day 90
Urofluometry.
Evaluation of indicators of urination. General urine analysis.
Time frame: Day 90
General urine analysis.
Evaluation of the inter-relapse period. Identification of an exacerbation of a chronic process.
Time frame: Month 3
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.
Time frame: Month 3
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.
Time frame: Month 6
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.
Time frame: Month 6
Percentage of patients with exacerbation of chronic prostatitis and signs of disease recurrence during the follow-up period.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.

Related trials for Chronic Prostatitis

Recruiting
EPPIC: Easing Pelvic Pain Interventions Clinical Research Program
Urologic Chronic Pelvic Pain Syndrome (UCPPS), Interstitial Cystitis
Enrolling by invitation
Pulsed Electromagnetic Versus Hydrotherapy on Chronic Pelvic Pain
Chronic Pelvic Pain Syndrome
Recruiting
Efficacy of Low-intensity Shockwave vs Radial Wave for Treatment of Erectile Dysfunction and Pelvic Pain
Erectile Dysfunction Due to Arterial Insufficiency, Erectile Dysfunction
RecruitingObservational study
Genetic Study of Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Prostatitis (CP), Chronic Pelvic Pain Syndrome (CPPS)
Recruiting
Oxiblume:CoQ10 (Ralivia) Therapy for Chronic Prostatitis/Chronic Pelvic Pain Syndrome (CP/CPPS)
Chronic Pelvic Pain Syndrome (CPPS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leonid Apanansky, Master study director

SPP Pharmaclon Ltd.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Interferon gamma human recombinant (IFN-G) in people with Chronic Prostatitis, run by SPP Pharmaclon Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dynamics of the total score and improvement in the quality of life on the scale IPSS. (time frame: Day 13). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05378646.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.