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Trial registered on ANZCTR


Registration number
ACTRN12619001554156
Ethics application status
Approved
Date submitted
30/08/2019
Date registered
12/11/2019
Date last updated
12/11/2019
Date data sharing statement initially provided
12/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Study to Evaluate Topical ABI-1968 Cervical Tissue Penetration in Subjects Prior to Hysterectomy Performed for Benign Indications
Scientific title
A study to evaluate topical ABI-1968 cervical tissue penetration after multiple weekly topical ABI-1968 administration intravaginally in subjects prior to hysterectomy performed for benign indications.
Secondary ID [1] 298987 0
ABI-1968-104
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hysterectomy for Benign Indications 313981 0
Condition category
Condition code
Renal and Urogenital 312379 312379 0 0
Pelvic inflammatory disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is designed to assess cervical tissue penetration of Topical ABI-1968 Gel after multiple weekly dosing in participants with and without cervical cap. Participants who are
scheduled to undergo hysterectomy for benign indication in approximately 4 weeks will be enrolled.
Up to 12 participants may be enrolled into one of four groups (3 participants per group).

Topical ABI-1968 Gel will be administered intra-vaginally by the Investigator or designee after visualizing the cervix in the dorsal lithotomy position. A single-use graduated applicator will be provided for administration of an approximately 2 g dose at a strength up to1%.
Eligible participants will receive study gel once weekly up to 4 doses administered by the clinician or designee in the clinic prior to the participant’s planned hysterectomy. One of two methods of delivery of the study gel to the cervix may be used: 1) Just 1% gel gel applied by the clinician directly to the cervix after visualization or 2) Just 1% gel gel Topical ABI-1968 Gel applied into the dome of a cervical cap or diaphragm and inserted blindly into the vagina by the clinician to cover the cervix.

Duration of treatment: Once weekly dosing up to a 4-week treatment period.
Based on safety data from an ongoing study it has been decided that all groups in Study ABI-1968-104 will receive 1.0% Topical ABI-1968 Gel for each dose.
Participants will be assigned to a dosing group by the Sponsor after a consultation with the Investigator.
Exact number of doses is determined in each participant by Four weekly dosing in groups 1 and 2 and up to 4 in group 3. Group 3 is for participants whose hysterectomy is scheduled such that they are unable to fit in a total of 4 weekly doses.

Group 1: Four weekly dosing of up to 1% of Topical ABI-1968 Gel with cervical cap
• Group 2: Four weekly dosing of up to 1% of Topical ABI-1968 Gel without cervical cap
• Group 3: Up to 4 weekly dosing up to 1% of Topical ABI-1968 Gel (with or without cervical
cap)
• Optional Group 4: Repeat the same dosing regimen used in previous groups or test a
different regimen (but not to exceed a dose up to 1% Topical ABI-1968 Gel and no more
than four weekly dosing).
• Group 5: Up to 4 weekly dosing just 1% gel of topical ABI-cream with a cervical cap.
Group 4 was incorporated to allow Sponsor to add additional participants should there be a need to further explore any finding from one of the other groups. Sponsor will review initial results and then consult with PIs as to whether there is a need to explore any group further
Treatment will be the same as one of the existing 3 groups. Which ever needs further investigation.
Intervention code [1] 315253 0
Treatment: Drugs
Comparator / control treatment
Different modes of administration, that is with or without cervical cap/diaphragm
Control group
Active

Outcomes
Primary outcome [1] 321016 0
To assess cervical tissue penetration of ABI-1968 using up to two in vitro technologies after
multiple weekly doses of Topical ABI-1968 Gel intravaginally.
Outcome Assessment: The presence of ABI-1968 and/or its metabolites in cervical tissue as measured by using the MALDI MS imaging and/or LC/MS assay
Timepoint [1] 321016 0
MALDI MS imaging and/or LC/MS assay will be performed throughout study.
Assessed on biopsy sample sent to lab post hysterectomy
Secondary outcome [1] 373700 0
To assess the safety and tolerability of Topical ABI-1968 Gel, when administered to subjects who will undergo hysterectomy for benign indications.
Outcome Assessment: Adverse events reported by the participants after ABI-1968 administration
Outcome is being assessed by adverse event monitoring and pelvic exam
Timepoint [1] 373700 0
Safety and tolerability will be performed throughout study.

Eligibility
Key inclusion criteria
1. Women between the ages of 30 and 55 years, who are premenopausal, with an intact uterus.
2. Generally, in good health with no clinically significant pulmonary, cardiac, gastroenterologic,
neurologic, renal, musculoskeletal, rheumatologic, metabolic, neoplastic, or
endocrine disease.
3. Scheduled for a hysterectomy for benign indications (e.g. fibroids, dysfunctional uterine
bleeding, urinary incontinence, pelvic pain etc).
4. Agree to abstain from activities such as sexual intercourse, vaginal douching or insertion of
any vaginal products other than the study drug for at least 48 hours after each dose and to
minimize partner exposure to Topical ABI-1968 Gel during study participation.
5. Able and willing to return to the clinic for all study procedures.
6. Able and willing to provide informed consent.
Minimum age
30 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Women who are pregnant
2. Women who are post-menopausal
3. History of cancer, except basal cell or squamous cell carcinoma of the skin.
4. Have a diagnosis of a gynecological cancer or suspicion of cancer that leads to the
hysterectomy
5. History of abnormal cervical cytology within the past 12 months
6. History of excisional (e.g. LEEP, LLETZ) or ablative (e.g. cryo- or electrocautery, laser)
treatment to the cervix
7. History of genital herpes with greater than 3 outbreaks per year, or active non-HPV vaginal infection.
8. Have an active pelvic infection (positive urine screen for gonorrhea or chlamydial infection,
positive bedside testing criteria for bacterial vaginosis, candida vaginitis or trichomonal
vaginitis, positive bimanual exam consistent with pelvic inflammatory disease).
9. Any clinically significant immune suppressing condition.
10. Participants with a significant acute condition or any other condition that in the opinion of the
Investigator might interfere with the evaluation of the study objectives.
11. Currently taking any of the following medications: over the counter (OTC) intra-vaginal
preparation, or any prescription that in the opinion of the Investigator could interfere with the
interpretation of the results, within 2 weeks of enrollment.
12. Hypersensitivity to any component of other nucleoside analogues (such as cidofovir, etc.).
13. Participation in any clinical study with an experimental medication or device within 30 days
or 5 half-lives (whichever is longer) of enrollment.
14. Menses expected to start within 7 days of enrollment.
15. Current alcohol or substance abuse as assessed by the Principal Investigator.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/10/2019
Date of last participant enrolment
Anticipated
1/12/2019
Actual
Date of last data collection
Anticipated
1/04/2020
Actual
Sample size
Target
15
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14768 0
Gold Coast University Hospital - Southport
Recruitment hospital [2] 14769 0
Mater Women's & Children's Private Health Services - South Brisbane
Recruitment postcode(s) [1] 28001 0
4215 - Southport
Recruitment postcode(s) [2] 28002 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 303526 0
Commercial sector/Industry
Name [1] 303526 0
Antiva Bioscience, Inc.
Country [1] 303526 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Antiva Bioscience, Inc.
Address
6000 Shoreline Court, Suite 203, South San Francisco, CA 94080
Country
United States of America
Secondary sponsor category [1] 303591 0
None
Name [1] 303591 0
Address [1] 303591 0
Country [1] 303591 0
Other collaborator category [1] 280904 0
Commercial sector/Industry
Name [1] 280904 0
Novotech (Australia) Pty Limited
Address [1] 280904 0
Level 3, 235 Pyrmont Street, Pyrmont NSW 2009
Country [1] 280904 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304053 0
Bellberry HREC
Ethics committee address [1] 304053 0
Ethics committee country [1] 304053 0
Australia
Date submitted for ethics approval [1] 304053 0
07/08/2019
Approval date [1] 304053 0
20/09/2019
Ethics approval number [1] 304053 0

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

Contacts
Principal investigator
Name 95658 0
Dr Paul Bertz
Address 95658 0
Mater Health Raymond Tce, Mater Hill South Brisbane Qld 4101
Country 95658 0
Australia
Phone 95658 0
+61 4 08 600 570
Fax 95658 0
Email 95658 0
Paul.Bretz@mater.org.au
Contact person for public queries
Name 95659 0
Frances Maguire
Address 95659 0
Mater Health Raymond Tce, Mater Hill South Brisbane Qld 4101
Country 95659 0
Australia
Phone 95659 0
+61 7 3163 5105
Fax 95659 0
Email 95659 0
frances.maguire@mater.org.au
Contact person for scientific queries
Name 95660 0
Mark McGovern
Address 95660 0
Antiva Biosciences, Inc.
6000 Shoreline Court, Suite 203, South San Francisco CA 94080
Country 95660 0
United States of America
Phone 95660 0
+1 650 822 1407
Fax 95660 0
Email 95660 0
mmcgovern@antivabio.com

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.