Condylomata AcuminataPhase 1/2NCT02535104
Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)
A Phase 1/2 study testing Ranpirnase in people with Condylomata Acuminata and Papillomavirus Infections, run by Tamir Biotechnology, Inc. at 1 site in Bolivia.
Trial summary
Ranpirnase in topical formulation is an antiviral drug being evaluated for the topical treatment of anogenital warts. The aims of this study is to evaluate the efficacy and safety of a topical formulation of ranpirnase in subjects with genital warts. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Condylomata Acuminata, Papillomavirus Infections, Sexually Transmitted Diseases
- What is being tested?
- Ranpirnase
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteBolivia
- Study dates
- Feb 2016to Sep 2016
- Phase
- Phase 1/2
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 lesions
- Accept to follow study instructions / signature of IC
- Abstain from sexual intercourse for 6 hours after applying the study product during the time of the study.
Who cannot join
- Any topical and/or destructive treatments for external genital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrollment (i.e., the randomization visit)
- Non pregnant. For women in reproductive age it would be required pregnancy test, and the use of double barrier contraceptives.
- Any of the following conditions:
- Known allergy to the study product
- Internal (rectal, urethral) warts that required or were undergoing treatment;
- A dermatological disease (e.g., psoriasis) or skin condition in the area, which may interfere with the evaluation.
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- Imiquimod 5% cream (Aldara®)
- Any marketed or investigational HPV vaccines
- Sinecatechins (Veregen)
- Interferon or interferon inducers
- Cytotoxic drugs
- Immunomodulators or immunosuppressives
- Oral or parenteral corticosteroids (inhaled/intranasal steroids are permitted)
- Oral antiviral drugs (with the exception of HAART, oral acyclovir and acyclovir related drugs) for suppressive or acute therapy herpes; or oseltamivir for prophylaxis or for influenza)
- Topical antiviral drugs (including topical acyclovir and acyclovir related drugs) in the areas under treatment
- Podophyllotoxin/Podofilox in the treatment areas
- Any topical prescription medications in the treatment areas
- Dermatologic procedures or surgery in the treatment areas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Clinical Study, Double Blinded, Multicentric, Controlled Against Placebo, in Parallel Groups, to Evaluate the Efficacy and Safety of a Topical Product Containing Ranpirnase in Genital Warts - HPV
Ranpirnase in topical formulation is an antiviral drug being evaluated for the topical treatment of anogenital warts. The aims of this study is to evaluate the efficacy and safety of a topical formulation of ranpirnase in subjects with genital warts.
Read the detailed description
The study consists of the evaluation of 4 weeks exposure to the study product; designed as randomized, double blinded, against vehicle to study the effects of 1 mg/ml concentration of ranpirnase on anogenital warts.
The dermal reaction are scored on a scale that describes the amount of erythema, edema, and other features indicative of irritation.
The clinical response are be scored on the basis of the percentage of the reduction of the lesions in size and number.
- Being tested
- Ranpirnase, Vehicle
- Medical subject headings
- Condylomata Acuminata, Papillomavirus Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanpirnaseDrug
Also called Onconase
Topical application by subject
VehicleDrug
Also called Placebo
Vehicle control
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | 1 mg/ml solution of ranpirnase applied twice daily Receives: Drug: Ranpirnase |
| Control | Placebo comparator | Vehicle - innert gel Receives: Drug: Vehicle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of lesions
The primary endpoint is the percentage change from baseline in total area of lesions at Week 8
Measured: Up to 60 days
Secondary outcomes (1)
Number of lesions
Number of lesions present at Week 8
Measured: Up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2015 (estimated)
- Study startFeb 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Condylomata AcuminataStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tamir Biotechnology, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edgar Valdez, MD, Study chair, Director - Research site
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535104
- Sponsor's protocol ID
- TAMIR1501HPV
- Status last verified
- Mar 2017
- First submitted
- 22 Aug 2015
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Clinical Study, Double Blinded, Multicentric, Controlled Against Placebo, in Parallel Groups, to Evaluate the Efficacy and Safety of a Topical Product Containing Ranpirnase in Genital Warts - HPV
- ClinicalTrials.gov ID
- NCT02535104
- Acronym / sponsor ID
- TAMIR1501HPV
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Tamir Biotechnology, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 Aug 2015 (estimated)
- 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.
Ranpirnase in topical formulation is an antiviral drug being evaluated for the topical treatment of anogenital warts. The aims of this study is to evaluate the efficacy and safety of a topical formulation of ranpirnase in subjects with genital warts.
Detailed description
The study consists of the evaluation of 4 weeks exposure to the study product; designed as randomized, double blinded, against vehicle to study the effects of 1 mg/ml concentration of ranpirnase on anogenital warts.
The dermal reaction are scored on a scale that describes the amount of erythema, edema, and other features indicative of irritation.
The clinical response are be scored on the basis of the percentage of the reduction of the lesions in size and number.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Ranpirnase1 mg/ml solution of ranpirnase applied twice daily |
| Control | Placebo comparator | Drug: VehicleVehicle - innert gel |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of external genital / perianal warts with at least 2 warts and no more than 30 lesions
- Accept to follow study instructions / signature of IC
- Abstain from sexual intercourse for 6 hours after applying the study product during the time of the study.
Key exclusion criteria (18 listed)
- Any topical and/or destructive treatments for external genital warts within 4 weeks (within 12 months for imiquimod and within 12 weeks for sinecatechins) prior to enrollment (i.e., the randomization visit)
- Non pregnant. For women in reproductive age it would be required pregnancy test, and the use of double barrier contraceptives.
- Any of the following conditions:
- Known allergy to the study product
- Internal (rectal, urethral) warts that required or were undergoing treatment;
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 |
|---|---|---|
| RanpirnaseAlso: OnconaseTopical application by subject | Drug | Treatment group |
| VehicleAlso: PlaceboVehicle control | Drug | Control |
Primary outcome
Size of lesions
Time frame: Up to 60 days
The primary endpoint is the percentage change from baseline in total area of lesions at Week 8
1 secondary outcome
Number of lesions
Time frame: Up to 60 days
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 6 Jun 2018.
- Individual participant dataSharing planned: Undecided
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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.
Edgar Valdez, MD study chair
Director - Research site
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Ranpirnase in people with Condylomata Acuminata and Papillomavirus Infections, run by Tamir Biotechnology, Inc. at 1 site in Bolivia.
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 3 inclusion and 18 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 6 Jun 2018. 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 Bolivia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Size of lesions (time frame: Up to 60 days). 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 6 Jun 2018.