Clinical trial · Interventional
Study of the Efficacy and Safety of the Drug Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts
Open Controlled Randomized Study of the Efficacy and Safety of Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts (Phase III)
NCT05156541CI-TRIAL-00055506ING-HPV-1completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anogenital Warts | — | UNRESOLVED | — |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interferon gamma human recombinant (IFN-G) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interferon
- 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.
- interventionNames
- Drug: Interferon gamma human recombinant (IFN-G)
- type
- NO_INTERVENTION
- label
- Control
- description
- Cryodestruction session only.
Primary outcomes (3)
- measure
- Recurrence of anogenital warts
- timeFrame
- Day 11
- description
- Number of participants with recurrent anogenital warts
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.