Study of the Efficacy and Safety of the Drug Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts
NCT ID: NCT05156541
Last Updated: 2021-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
30 participants
INTERVENTIONAL
2009-05-18
2010-07-15
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Interferon gamma human recombinant (IFN-G)
received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
Control
Cryodestruction session only.
No interventions assigned to this group
Interventions
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Interferon gamma human recombinant (IFN-G)
received by microbiological synthesis; specific antiviral activity on cells is 2x10\*7 Units per mg of protein
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
50 Years
ALL
No
Sponsors
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SPP Pharmaclon Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Leonid Apanansky, Master
Role: STUDY_DIRECTOR
SPP Pharmaclon Ltd.
Locations
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State scientific center of a dermatovenereology and cosmetology
Moscow, , Russia
Countries
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Other Identifiers
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ING-HPV-1
Identifier Type: -
Identifier Source: org_study_id