Human Papillomavirus InfectionPhase 3ING-HPV-1NCT05156541
Study of the Efficacy and Safety of the Drug Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts
A Phase 3 study testing Interferon gamma human recombinant (IFN-G) in people with Human Papillomavirus Infection and Anogenital Warts, run by SPP Pharmaclon Ltd. at 1 site in Russia.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Human Papillomavirus Infection, Anogenital Warts
- What is being tested?
- Interferon gamma human recombinant (IFN-G)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 18 May 2009to 15 Jul 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Russia1 site
State scientific center of a dermatovenereology and cosmetology
Moscow, 107076
About this study
Official title: 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.
Read the 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.
- Conditions
- Human Papillomavirus Infection, Anogenital Warts
- Being tested
- Interferon gamma human recombinant (IFN-G)
- Keywords
- interferon gamma, IFN-g, HPV, Anogenital warts
- Medical subject headings
- Papillomavirus Infections, Condylomata Acuminata
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interferon gamma human recombinant (IFN-G)Drug
Also called Ingaron, Interferon gamma human recombinant
received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein
| Study group | Role | What they receive |
|---|---|---|
| Interferon | Experimental | After a cryodestruction session, therapy with Ingaron 100,000 IU once a day every other day. The course of treatment consisted of 5 injections. Receives: Drug: Interferon gamma human recombinant (IFN-G) |
| Control | No intervention | Cryodestruction session only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of anogenital warts
Number of participants with recurrent anogenital warts
Measured: Day 11
Recurrence of anogenital warts
Number of participants with recurrent anogenital warts
Measured: Day 40
Recurrence of anogenital warts
Number of participants with recurrent anogenital warts
Measured: Day 100
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2021
- Study start18 May 2009
- Primary completion30 Jun 2010
- Study completion15 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- SPP Pharmaclon Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonid Apanansky, Master, Study director, SPP Pharmaclon Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05156541
- Sponsor's protocol ID
- ING-HPV-1
- Acronym
- ING-HPV-1
- Status last verified
- Nov 2021
- First submitted
- 15 Nov 2021
- Last updated
- 14 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Controlled Randomized Study of the Efficacy and Safety of Ingaron (Interferon-gamma) in the Treatment of Anogenital Warts (Phase III)
- ClinicalTrials.gov ID
- NCT05156541
- Acronym / sponsor ID
- ING-HPV-1 / ING-HPV-1
- Conditions
- Human Papillomavirus Infection, Anogenital Warts
- Keywords
- interferon gamma, IFN-g, HPV, Anogenital warts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SPP Pharmaclon Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 May 2009 (actual)
- Primary completion
- 30 Jun 2010 (actual)
- Study completion
- 15 Jul 2010 (actual)
- First posted
- 14 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interferon | Experimental | Drug: Interferon gamma human recombinant (IFN-G)After a cryodestruction session, therapy with Ingaron 100,000 IU once a day every other day. The course of treatment consisted of 5 injections. |
| Control | No intervention | –Cryodestruction session only. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interferon gamma human recombinant (IFN-G)Also: Ingaron, Interferon gamma human recombinantreceived by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein | Drug | Interferon |
Primary outcome
Recurrence of anogenital warts
Time frame: Day 11
Number of participants with recurrent anogenital warts
Recurrence of anogenital warts
Time frame: Day 40
Number of participants with recurrent anogenital warts
Recurrence of anogenital warts
Time frame: Day 100
Number of participants with recurrent anogenital warts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leonid Apanansky, Master study director
SPP Pharmaclon Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interferon gamma human recombinant (IFN-G) in people with Human Papillomavirus Infection and Anogenital Warts, run by SPP Pharmaclon Ltd. at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of anogenital warts (time frame: Day 11). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2021.