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

Human Papillomavirus Infection Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05156541
• Other study ID #: ING-HPV-1
• Status: Completed
• Phase: Phase 3
• Start date: May 18, 2009
• Est. completion date: July 15, 2010

Study information

• Verified date: November 2021
• Source: SPP Pharmaclon Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 15, 2010
• Est. primary completion date: June 30, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anogenital Warts
• Condylomata Acuminata
• Human Papillomavirus Infection
• Papillomavirus Infections
• Warts

Intervention

Drug:
• Interferon gamma human recombinant (IFN-G)
received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein

Locations

Country	Name	City	State
Russian Federation	State scientific center of a dermatovenereology and cosmetology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
SPP Pharmaclon Ltd.

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of anogenital warts	Number of participants with recurrent anogenital warts	Day 11
Primary	Recurrence of anogenital warts	Number of participants with recurrent anogenital warts	Day 40
Primary	Recurrence of anogenital warts	Number of participants with recurrent anogenital warts	Day 100