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

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SPP Pharmaclon Ltd.
• Treatments: Interferon-gamma; Interferons

Criteria

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.