Study of the Efficacy and Safety of the Drug Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts (ING-HPV-1)

Open Controlled Randomized Study of the Efficacy and Safety of Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts (Phase III)

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.

Study Overview

• Status: Completed
• Conditions: Human Papillomavirus Infection; Anogenital Warts
• Intervention / Treatment: Drug: Interferon gamma human recombinant (IFN-G)

Detailed Description

Literature data and the results of preclinical studies of interferon-gamma, as well as the features of HPV immunopathogenesis, show the expediency of studying the use of Ingaron in this pathology.

The study was planned to include 50 outpatients of both sexes aged 18 to 50 years with a confirmed diagnosis of anogenital warts.

In the course of the study, Ingaron was administered at a dose of 100,000 IU once a day every other day in the period of 10 days.

Patients were divided into 2 groups: study and control.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 107076
    • State scientific center of a dermatovenereology and cosmetology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patients of both sexes aged 18 to 50 years with a diagnosis of "Anogenital warts".
2. The diagnosis "Anogenital warts" was made for the first time at least one year before inclusion in the study.
3. During the last year prior to inclusion in the study, the patient had at least 2 recurrences of anogenital warts.
4. The diagnosis is confirmed by the detection of HPV by polymerase chain reaction (PCR).
5. Negative pregnancy test in women.
6. Availability of written informed consent to participate in the study.

Exclusion Criteria:

1. 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.
2. Unsystematic use of barrier methods of contraception.
3. Pregnancy and lactation.
4. Known allergic reactions to interferons and / or other significant allergic diseases.
5. Any immunotropic therapy within the last 6 weeks prior to enrollment in the study.
6. The need to take drugs prohibited during the study.
7. Condition after organ transplantation, constant intake of immunosuppressive drugs.
8. 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.
9. 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.
10. The presence of severe pathology on the part of the respiratory system, gastrointestinal tract, hematopoietic system.
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 efficacy and safety data obtained in this research.
12. Alcohol and / or drug dependence.
13. Participation in other clinical trials in the last three months prior to inclusion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interferon; 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); received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein; Other Names: Ingaron; Interferon gamma human recombinant
No Intervention: Control; Cryodestruction session only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: SPP Pharmaclon Ltd.
• Investigators: Study Director: Leonid Apanansky, Master, SPP Pharmaclon Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 18, 2009
• Primary Completion (Actual): June 30, 2010
• Study Completion (Actual): July 15, 2010

Study Registration Dates

• First Submitted: November 15, 2021
• First Submitted That Met QC Criteria: November 30, 2021
• First Posted (Actual): December 14, 2021

Study Record Updates

• Last Update Posted (Actual): December 14, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: HPV; interferon gamma; Anogenital warts; IFN-g
• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Tumor Virus Infections; Warts; Papillomavirus Infections; Condylomata Acuminata; Anti-Infective Agents; Antiviral Agents; Antineoplastic Agents; Interferons; Interferon-gamma
• Other Study ID Numbers: ING-HPV-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No