Trial Outcomes & Findings for Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata (NCT NCT02410018)

NCT ID: NCT02410018

Last Updated: 2018-12-05

Results Overview

Short-term safety of OCL 503 at 7 days post treatment of women with leiomyomata by UAE, as measured by Adverse Events reporting - Serious Adverse Events

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2018-12-05

Participant Flow

Participant milestones

Measure	Cohort 1 - Uterine Artery Embolization Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Cohort 2 - Uterine Artery Embolization Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Overall Study STARTED	2	1
Overall Study COMPLETED	2	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness of OCL 503 in the Treatment of Women With Leiomyomata

Baseline characteristics by cohort

Measure	Cohort 1 - Uterine Artery Embolization n=2 Participants Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Cohort 2 - Uterine Artery Embolization n=1 Participants Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Total n=3 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	2 participants n=5 Participants	1 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Short-term safety of OCL 503 at 7 days post treatment of women with leiomyomata by UAE, as measured by Adverse Events reporting - Serious Adverse Events

Outcome measures

Measure	Cohort 1 - Uterine Artery Embolization n=2 Participants Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Cohort 2 - Uterine Artery Embolization n=1 Participants Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Number of Participants With Serious Adverse Events	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline and 7 days

Number of participants with decreased fibroid perfusion from baseline at 7 days post treatment of women with leiomyomata by UAE - Decreased Fibroid Perfusion Fibroid perfusion indicative of blood flowing to the fibroid at baseline and 7 days after embolization was determined using MRI.

Outcome measures

Measure	Cohort 1 - Uterine Artery Embolization n=2 Participants Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Cohort 2 - Uterine Artery Embolization n=1 Participants Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Change in Fibroid Perfusion From Baseline at 7 Days Post Treatment	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 28 days

Short-term safety of OCL 503 at 28 days post treatment of women with leiomyomata by UAE, as measured by Adverse Events reporting - Serious Adverse Events

Outcome measures

Measure	Cohort 1 - Uterine Artery Embolization n=2 Participants Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Cohort 2 - Uterine Artery Embolization n=1 Participants Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Number of Participants With Serious Adverse Events	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline and 28 days

Population: Decrease in fibroid perfusion

Number of participants with decreased fibroid perfusion from baseline at 28 days post treatment of women with leiomyomata by UAE.

Outcome measures

Measure	Cohort 1 - Uterine Artery Embolization Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Cohort 2 - Uterine Artery Embolization n=1 Participants Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Change in Fibroid Perfusion From Baseline at 28 Days Post Treatment of Women With Leiomyomata by UAE	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 7 days

Population: Histological assessment of uterine tissue was conducted for Cohort 1 at 7-days, post-embolization. Histological assessment of uterine tissue was conducted for Cohort 2 at 28-days, post-embolization.

Tissue necrosis assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Fibroid necrosis observed

Outcome measures

Measure	Cohort 1 - Uterine Artery Embolization n=2 Participants Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Cohort 2 - Uterine Artery Embolization n=1 Participants Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Tissue Necrosis Assessed by Histology Graded Scale at 7 Days Post Treatment of Women With Leiomyomata by UAE	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 7 days

Population: Inflammatory response for Cohort 1 was assessed at 7-days, post-embolization. Inflammatory response for Cohort-2 was assessed at 28-days, post-embolization.

Inflammatory response assessed by histology at 7 days post treatment of women with leiomyomata by UAE - Perivascular inflammation - Low Grade

Outcome measures

Measure	Cohort 1 - Uterine Artery Embolization n=2 Participants Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Cohort 2 - Uterine Artery Embolization n=1 Participants Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Inflammatory Response Assessed by Histology at 7 Days Post Treatment of Women With Leiomyomata by UAE	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Histological assessment of uterine tissue was conducted at 7-days for Cohort 1 and 28-days for Cohort 2, post-embolization.

Tissue necrosis assessed by histology graded scale at 28 days post treatment of women with leiomyomata by UAE - Fibroid Necrosis

Outcome measures

Measure	Cohort 1 - Uterine Artery Embolization n=2 Participants Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Cohort 2 - Uterine Artery Embolization n=1 Participants Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Tissue Necrosis Assessed by Histology Graded Scale at 28 Days Post Treatment of Women With Leiomyomata by UAE	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 28 days

Population: Inflammatory response was conducted at 7-days post-embolization for Cohort 1 and 28-days for Cohort 2, post-embolization.

Inflammatory response assessed by histology at 28 days post treatment of women with leiomyomata by UAE - Perivascular Low Grade

Outcome measures

Measure	Cohort 1 - Uterine Artery Embolization n=2 Participants Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Cohort 2 - Uterine Artery Embolization n=1 Participants Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Inflammatory Response Assessed by Histology at 28 Days Post Treatment of Women With Leiomyomata by UAE	0 Participants	1 Participants

Adverse Events

Cohort 1 - Uterine Artery Embolization

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Cohort 2 - Uterine Artery Embolization

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort 1 - Uterine Artery Embolization n=2 participants at risk Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Cohort 2 - Uterine Artery Embolization n=1 participants at risk Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Reproductive system and breast disorders Fibroid expulsion	0.00% 0/2 • Day 0 through 28 days.	0.00% 0/1 • Day 0 through 28 days.

Other adverse events

Measure	Cohort 1 - Uterine Artery Embolization n=2 participants at risk Women treated with OCL 503 proceeding to hysterectomy 1 week post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.	Cohort 2 - Uterine Artery Embolization n=1 participants at risk Women treated with OCL 503 proceeding to hysterectomy 1 month post embolization. OCL 503 will be administered by catheter to the uterine artery(ies) to achieve blood flow stasis. OCL 503 (uterine artery embolization): Transcatheter embolization of the uterine artery(ies) using an embolic agent.
Investigations Post-embolization Syndrome	100.0% 2/2 • Number of events 2 • Day 0 through 28 days.	100.0% 1/1 • Number of events 1 • Day 0 through 28 days.

Additional Information

President

IMBiotechnologies Ltd

Phone: 780-945-6609

Email: mstewart@tbwifi.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place