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

Primary Purpose

Human Papillomavirus Infection, Anogenital Warts

Status

Completed

Phase

Phase 3

Locations

Russian Federation

Study Type

Interventional

Intervention

Interferon gamma human recombinant (IFN-G)

About this trial

This is an interventional treatment trial for Human Papillomavirus Infection focused on measuring interferon gamma, IFN-g, HPV, Anogenital warts

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients of both sexes aged 18 to 50 years with a diagnosis of "Anogenital warts".
The diagnosis "Anogenital warts" was made for the first time at least one year before inclusion in the study.
During the last year prior to inclusion in the study, the patient had at least 2 recurrences 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.

Exclusion Criteria:

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.
Participation in other clinical trials in the last three months prior to inclusion.

Sites / Locations

State scientific center of a dermatovenereology and cosmetology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Interferon

Control

Arm Description

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

Cryodestruction session only.

Outcomes

Primary Outcome Measures

Recurrence of anogenital warts

Number of participants with recurrent anogenital warts

Recurrence of anogenital warts

Number of participants with recurrent anogenital warts

Recurrence of anogenital warts

Number of participants with recurrent anogenital warts

Secondary Outcome Measures

Full Information

NCT ID

NCT05156541

First Posted

November 15, 2021

Last Updated

November 30, 2021

Sponsor

SPP Pharmaclon Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05156541

Brief Title

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

Acronym

ING-HPV-1

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

May 18, 2009 (Actual)

Primary Completion Date

June 30, 2010 (Actual)

Study Completion Date

July 15, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SPP Pharmaclon Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Human Papillomavirus Infection, Anogenital Warts

Keywords

interferon gamma, IFN-g, HPV, Anogenital warts

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Interferon

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

No Intervention

Arm Description

Cryodestruction session only.

Intervention Type

Drug

Intervention Name(s)

Interferon gamma human recombinant (IFN-G)

Other Intervention Name(s)

Ingaron, Interferon gamma human recombinant

Intervention Description

received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein

Primary Outcome Measure Information:

Title

Recurrence of anogenital warts

Description

Number of participants with recurrent anogenital warts

Time Frame

Day 11

Title

Recurrence of anogenital warts

Description

Number of participants with recurrent anogenital warts

Time Frame

Day 40

Title

Recurrence of anogenital warts

Description

Number of participants with recurrent anogenital warts

Time Frame

Day 100

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients of both sexes aged 18 to 50 years with a diagnosis of "Anogenital warts". The diagnosis "Anogenital warts" was made for the first time at least one year before inclusion in the study. During the last year prior to inclusion in the study, the patient had at least 2 recurrences 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. Exclusion Criteria: 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. Participation in other clinical trials in the last three months prior to inclusion.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leonid Apanansky, Master

Organizational Affiliation

SPP Pharmaclon Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

State scientific center of a dermatovenereology and cosmetology

City

Moscow

ZIP/Postal Code

107076

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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