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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03239223




Registration number
NCT03239223
Ethics application status
Date submitted
1/08/2017
Date registered
3/08/2017

Titles & IDs
Public title
Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection
Scientific title
A Randomised, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability and Pharmacokinetics of Topical ABI-1968 in Subjects With Cervical High Grade Squamous Intreaepithelial Lesions (cHSIL)
Secondary ID [1] 0 0
ABI-1968-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HSIL 0 0
HSIL of Cervix 0 0
High-Grade Squamous Intraepithelial Lesions 0 0
High-grade Cervical Intraepithelial Neoplasia 0 0
Human Papilloma Virus 0 0
Cervical Cancer 0 0
Cervical Intraepithelial Neoplasia 0 0
Cervical Neoplasm 0 0
Cervical Dysplasia 0 0
CIN 0 0
Condition category
Condition code
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)
Cancer 0 0 0 0
Cervical (cervix)
Cancer 0 0 0 0
Breast
Infection 0 0 0 0
Other infectious diseases
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABI-1968

Experimental: Dose 1 - Multiple Ascending Dose (MAD) - ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22

Experimental: Dose 2 - Multiple Ascending Dose (MAD) - ABI-1968 or Placebo topical cream applied at Day 1, Day 8, Day 15 and Day 22


Treatment: Drugs: ABI-1968
Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Tolerated Dose (MTD) of ABI-1968 for the treatment of cHSIL
Timepoint [1] 0 0
85 Days
Secondary outcome [1] 0 0
Systemic exposure to Topical ABI-1968 Cream following topical application to the cervix.
Timepoint [1] 0 0
85 Days
Secondary outcome [2] 0 0
Histopathology of areas with biopsy-proven disease following multiple doses of Topical ABI-1968 Cream.
Timepoint [2] 0 0
85 Days

Eligibility
Key inclusion criteria
* Women, 25 to 50 years old.
* Cervical HSIL diagnosis made within 2 months of enrollment and confirmed with biopsy with no evidence of invasive cancer in any specimen and must be p16+.
* Able and willing to abstain from sexual intercourse for 48 hours prior to first dose and 2 days after each dose.
* Generally experiencing regular menstrual cycles, unless using long-acting reversible contraception that induces amenorrhea (e.g., Mirena IUD, Norplant).
Minimum age
25 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Women who are pregnant, plan to become pregnant in the next 4 months, or lactating females.
* History of cancer, except basal cell or squamous cell carcinoma of the skin.
* History of genital herpes with > 3 outbreaks per year, or active non-HPV vaginal infection.
* Plan to have excision or ablation of the lesion(s) within 3 months of enrollment.
* History of cervical cancer, colposcopy suspicious for cancer, any prior treatment of CIN, or hysterectomy.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/10/2018
Sample size
Target
Accrual to date
Final
16
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Research Center - Camperdown
Recruitment hospital [2] 0 0
Research Center - Darlinghurst
Recruitment hospital [3] 0 0
Research Center - South Brisbane
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
4101 - South Brisbane
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Idaho
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Antiva Biosciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03239223