NCT05378646

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: SPP Pharmaclon Ltd. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Prostatitis

Interventions

Type	Name	Description
DRUG	Interferon gamma human recombinant (IFN-G)	received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein

Timeline

• Start date: 2009-01-29
• Primary completion: 2009-12-31
• Completion: 2010-02-01
• First posted: 2022-05-18
• Last updated: 2022-05-18