Safety and Efficacy Study of Topical Ranpirnase to Treat Genital Warts (HPV)

NCT02535104 | Completed Phase 1

• 1 other identifier: TAMIR1501HPV
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Condylomata Acuminata; Papillomavirus Infections; Sexually Transmitted Diseases

Outcome Measures

Primary Outcomes (1)

• Size of lesions

  The primary endpoint is the percentage change from baseline in total area of lesions at Week 8

  Up to 60 days

Secondary Outcomes (1)

• Number of lesions

  Up to 60 days

Study Arms (2)

Treatment group

EXPERIMENTAL

1 mg/ml solution of ranpirnase applied twice daily

Drug: Ranpirnase

Control

PLACEBO COMPARATOR

Vehicle - innert gel

Drug: Vehicle

Interventions

Ranpirnase DRUG

Topical application by subject

Also known as: Onconase

Treatment group

Vehicle DRUG

Vehicle control

Also known as: Placebo

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Tamir Biotechnology, Inc.: lead

Study Sites (1)

IDH

Cochabamba, Bolivia

Location

MeSH Terms

Conditions

Condylomata Acuminata; Papillomavirus Infections; Sexually Transmitted Diseases

Interventions

ranpirnase

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Warts; Skin Diseases, Viral; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Edgar Valdez, MD

  Director - Research site

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2015
• First Posted: August 28, 2015
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 6, 2018

Record last verified: 2017-03

Locations

BO (1)