Study of the Efficacy and Safety of the Drug Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts

NCT05156541 | Completed Phase 3

• 1 other identifier: ING-HPV-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to evaluate the effectiveness of destructive therapy for anogenital warts in combination with the use of Ingaron in comparison with destructive therapy.

Conditions

Human Papillomavirus Infection; Anogenital Warts

Keywords

interferon gamma; IFN-g; HPV; Anogenital warts

Outcome Measures

Primary Outcomes (3)

• Recurrence of anogenital warts

  Number of participants with recurrent anogenital warts

  Day 11

• Recurrence of anogenital warts

  Number of participants with recurrent anogenital warts

  Day 40

• Recurrence of anogenital warts

  Number of participants with recurrent anogenital warts

  Day 100

Study Arms (2)

Interferon

EXPERIMENTAL

After a cryodestruction session, therapy with Ingaron 100,000 IU once a day every other day. The course of treatment consisted of 5 injections.

Drug: Interferon gamma human recombinant (IFN-G)

Control

NO INTERVENTION

Cryodestruction session only.

Interventions

Interferon gamma human recombinant (IFN-G) DRUG

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

Interferon

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients of both sexes aged 18 to 50 years with a diagnosis of "Anogenital warts".
• The diagnosis is confirmed by the detection of HPV by polymerase chain reaction (PCR).
• Negative pregnancy test in women.
• Availability of written informed consent to participate in the study.

You may not qualify if:

• Positive test results for syphilis, hepatitis (HbsAg, anti-HCV), HIV infection, gonococcal infection, urogenital trichomoniasis, chlamydial infection, inflammatory diseases of the urogenital system caused by genital mycoplasmas.
• Unsystematic use of barrier methods of contraception.
• Pregnancy and lactation.
• Known allergic reactions to interferons and / or other significant allergic diseases.
• Any immunotropic therapy within the last 6 weeks prior to enrollment in the study.
• The need to take drugs prohibited during 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 on the part 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 (content of creatinine\> 1.5 mg / dL); signs of hepatic and / or renal failure.
• The presence of severe pathology on the part of the respiratory system, gastrointestinal tract, hematopoietic system.
• 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 efficacy and safety data obtained in this research.
• Alcohol and / or drug dependence.

Sponsors & Collaborators

• SPP Pharmaclon Ltd.: lead

Study Sites (1)

State scientific center of a dermatovenereology and cosmetology

Moscow, 107076, Russia

Location

MeSH Terms

Conditions

Papillomavirus Infections; Condylomata Acuminata

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Warts; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Leonid Apanansky, Master

  SPP Pharmaclon Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2021
• First Posted: December 14, 2021
• Study Start: May 18, 2009
• Primary Completion: June 30, 2010
• Study Completion: July 15, 2010
• Last Updated: December 14, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)