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A Study to Evaluate Adverse Events and Effectiveness of OnabotulinumtoxinA in Participants Undergoing Open Abdominal Ventral Hernia Repair for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique

Primary Purpose

Ventral Hernia, Abdominal Hernia

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BOTOX Dose A
Placebo for BOTOX
BOTOX Dose B
BOTOX Dose C
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia focused on measuring OnabotulinumtoxinA, BOTOX, Abdomen, Primary fascial closure

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participant is in good health as determined by medical history, vital signs, and investigator's judgment, including no known active pandemic infection. Body Mass Index (BMI) at screening is <= 40 kg/m2. Participant meets the following disease activity criteria: Intact abdominal wall muscles (defined as no prior dissection to the lateral abdominal wall complex) based on screening CT scan. Midline ventral hernia requiring surgical repair, at least 6 cm, and not more than 18 cm in transverse defect width at the widest part of the of the hernia defect, as assessed on CT scan by the investigator. Any portion of the ventral hernia does not extend > 3 cm into the M1 subxiphoid zone or into the M5 zone using the 2009 classification by the European Hernia Society. No history of prior onlay hernia mesh wider than rectus. No hernia with loss of domain >20% as determined by the investigator, using Sabbagh method. Exclusion Criteria: Presence of a medical condition that may put the participant at increased risk with exposure to onabotulinumtoxinA, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function. Presence or history of any of the following within 3 months prior to the randomization visit that may indicate a vulnerable respiratory state per the investigator's clinical judgment, for example, aspiration pneumonia, lower respiratory tract infections, uncontrolled asthma, severe chronic obstructive pulmonary disease, or otherwise compromised respiratory function. History of ongoing or anticipated need to perform progressive preoperative pneumoperitoneum or other tissue expansion technique for repair of ventral hernia. Planned ostomy reversal, panniculectomy bariatric procedure, or vascular procedure requiring anticoagulants during the study. History of abdominal or hernia repair surgery requiring hospitalization within 6 months prior to screening. History of a contraindication to BOTOX and/or hypersensitivity reactions to BOTOX.

Sites / Locations

  • NYU Langone Hospital-Long Island /ID# 251280
  • Atrium Health Carolinas Medical Center /ID# 247711

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1, BOTOX Dose A

Cohort 1, BOTOX Dose B

Cohort 1, Placebo

Cohort 2, BOTOX Dose A

Cohort 2, BOTOX Dose B

Cohort 2, BOTOX Dose C

Cohort 2, Placebo

Cohort 3, BOTOX Dose A

Cohort 3, BOTOX Dose B

Cohort 3, BOTOX Dose C

Cohort 3, Placebo

Arm Description

Participants will receive BOTOX Dose A

Participants will receive BOTOX Dose B.

Participants will receive placebo for BOTOX.

Participants will receive BOTOX Dose A

Participants will receive BOTOX Dose B

Participants will receive BOTOX Dose C

Participants will receive placebo for BOTOX

Participants will receive BOTOX Dose A

Participants will receive BOTOX Dose B.

Participants will receive BOTOX Dose C.

Participants will receive placebo for BOTOX.

Outcomes

Primary Outcome Measures

Percentage of participants with achievement of primary fascial closure (PFC) without the use of component separation techniques (CST) in open ventral hernia surgical repair
PFC will be defined as the ability to achieve fascia to fascia midline approximation. CST will be defined as the release of the external oblique muscle or the transection of transversus abdominis muscle (known as posterior component separation with transversus abdominis release (TAR).

Secondary Outcome Measures

Percentage of participants with achievement of PFC
PFC will be defined as the ability to achieve fascia to fascia midline approximation.
Percentage of participants with usage of CST for the purpose of PFC
CST will be defined as the release of the external oblique muscle or the transection of transversus abdominis muscle (known as posterior component separation with transversus abdominis release (TAR).
Number of lateral abdominal wall muscles released among participants who required CST use to achieve PFC as reported by the operating surgeon
Lateral abdominal wall muscles are released by TAR and external oblique release (unilateral or bilateral)
Change in length of lateral abdominal wall complex
Change in length of lateral abdominal wall complex as measured by abdominal CT scan in supine position prior to surgical repair will be assessed.
Change in Width to the Hernia Defect
Change from screening in width to the hernia defect as measured by abdominal CT scan in supine position prior to surgical repair will be assessed.
Change from screening in length of lateral abdominal wall complex
Change from screening in length of lateral abdominal wall complex as measured by abdominal CT scan performing Valsalva maneuver prior to surgical repair will be assessed.
Change from screening in width to the hernia defect
Change from screening in width to the hernia defect as measured by abdominal CT scan performing Valsalva maneuver prior to surgical repair

Full Information

First Posted
November 1, 2022
Last Updated
October 5, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05606757
Brief Title
A Study to Evaluate Adverse Events and Effectiveness of OnabotulinumtoxinA in Participants Undergoing Open Abdominal Ventral Hernia Repair for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique
Official Title
A Phase 2b Double-Blind, Placebo-Controlled, Adaptive, Dose-Escalation Study to Evaluate the Safety and Efficacy of OnabotulinumtoxinA for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique, in Subjects Undergoing Open Abdominal Ventral Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 29, 2023 (Anticipated)
Primary Completion Date
April 22, 2025 (Anticipated)
Study Completion Date
May 19, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Ventral hernias form when there is a loss of integrity of the abdominal wall muscles. Abdominal hernias can expand and can cause severe pain as the abdominal wall weakens. The purpose of this study is to evaluate the safety and efficacy of a range of onabotulinumtoxinA (BOTOX) doses to achieve primary fascial closure (PFC) without use of component separation technique (CST) in ventral hernia surgical repair. BOTOX is an investigational drug being developed for the treatment of ventral hernias. In this dose escalation study, participants will be placed in 1 of 3 cohorts. Cohort 1 will be randomized to receive placebo or 1 of 2 BOTOX doses, after which time Cohort 2 will be randomized to receive placebo or 1 of 3 BOTOX doses. Participants in Cohort 3 will be randomized to receive placebo or 1 of 3 BOTOX doses. Adult participants undergoing open abdominal ventral hernia repair will be enrolled. Around 200 participants will be enrolled in the study at approximately 20 sites in the United States. Participants will receive a single intramuscular injection of BOTOX Dose A, BOTOX Dose B, BOTOX Dose C, or placebo. There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will be followed for approximately 3 months after surgery and will receive a follow-up phone call 30 days (+/-) their last study visit. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia, Abdominal Hernia
Keywords
OnabotulinumtoxinA, BOTOX, Abdomen, Primary fascial closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1, BOTOX Dose A
Arm Type
Experimental
Arm Description
Participants will receive BOTOX Dose A
Arm Title
Cohort 1, BOTOX Dose B
Arm Type
Experimental
Arm Description
Participants will receive BOTOX Dose B.
Arm Title
Cohort 1, Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo for BOTOX.
Arm Title
Cohort 2, BOTOX Dose A
Arm Type
Experimental
Arm Description
Participants will receive BOTOX Dose A
Arm Title
Cohort 2, BOTOX Dose B
Arm Type
Experimental
Arm Description
Participants will receive BOTOX Dose B
Arm Title
Cohort 2, BOTOX Dose C
Arm Type
Experimental
Arm Description
Participants will receive BOTOX Dose C
Arm Title
Cohort 2, Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo for BOTOX
Arm Title
Cohort 3, BOTOX Dose A
Arm Type
Experimental
Arm Description
Participants will receive BOTOX Dose A
Arm Title
Cohort 3, BOTOX Dose B
Arm Type
Experimental
Arm Description
Participants will receive BOTOX Dose B.
Arm Title
Cohort 3, BOTOX Dose C
Arm Type
Experimental
Arm Description
Participants will receive BOTOX Dose C.
Arm Title
Cohort 3, Placebo
Arm Type
Experimental
Arm Description
Participants will receive placebo for BOTOX.
Intervention Type
Drug
Intervention Name(s)
BOTOX Dose A
Other Intervention Name(s)
OnabotulinumtoxinA
Intervention Description
Injection; intramuscular
Intervention Type
Drug
Intervention Name(s)
Placebo for BOTOX
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
BOTOX Dose B
Other Intervention Name(s)
OnabotulinumtoxinA
Intervention Description
Injection; intramuscular
Intervention Type
Drug
Intervention Name(s)
BOTOX Dose C
Other Intervention Name(s)
OnabotulinumtoxinA
Intervention Description
Injection; intramuscular
Primary Outcome Measure Information:
Title
Percentage of participants with achievement of primary fascial closure (PFC) without the use of component separation techniques (CST) in open ventral hernia surgical repair
Description
PFC will be defined as the ability to achieve fascia to fascia midline approximation. CST will be defined as the release of the external oblique muscle or the transection of transversus abdominis muscle (known as posterior component separation with transversus abdominis release (TAR).
Time Frame
Up to 4 Months
Secondary Outcome Measure Information:
Title
Percentage of participants with achievement of PFC
Description
PFC will be defined as the ability to achieve fascia to fascia midline approximation.
Time Frame
Up to 4 Months
Title
Percentage of participants with usage of CST for the purpose of PFC
Description
CST will be defined as the release of the external oblique muscle or the transection of transversus abdominis muscle (known as posterior component separation with transversus abdominis release (TAR).
Time Frame
Up to 4 Months
Title
Number of lateral abdominal wall muscles released among participants who required CST use to achieve PFC as reported by the operating surgeon
Description
Lateral abdominal wall muscles are released by TAR and external oblique release (unilateral or bilateral)
Time Frame
Up to 4 Months
Title
Change in length of lateral abdominal wall complex
Description
Change in length of lateral abdominal wall complex as measured by abdominal CT scan in supine position prior to surgical repair will be assessed.
Time Frame
Up to 4 Months
Title
Change in Width to the Hernia Defect
Description
Change from screening in width to the hernia defect as measured by abdominal CT scan in supine position prior to surgical repair will be assessed.
Time Frame
Up to 4 Months
Title
Change from screening in length of lateral abdominal wall complex
Description
Change from screening in length of lateral abdominal wall complex as measured by abdominal CT scan performing Valsalva maneuver prior to surgical repair will be assessed.
Time Frame
Up to 4 Months
Title
Change from screening in width to the hernia defect
Description
Change from screening in width to the hernia defect as measured by abdominal CT scan performing Valsalva maneuver prior to surgical repair
Time Frame
Up to 4 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participant is in good health as determined by medical history, vital signs, and investigator's judgment, including no known active pandemic infection. Body Mass Index (BMI) at screening is <= 40 kg/m2. Participant meets the following disease activity criteria: Intact abdominal wall muscles (defined as no prior dissection to the lateral abdominal wall complex) based on screening CT scan. Midline ventral hernia requiring surgical repair, at least 6 cm, and not more than 18 cm in transverse defect width at the widest part of the of the hernia defect, as assessed on CT scan by the investigator. Any portion of the ventral hernia does not extend > 3 cm into the M1 subxiphoid zone or into the M5 zone using the 2009 classification by the European Hernia Society. No history of prior onlay hernia mesh wider than rectus. No hernia with loss of domain >20% as determined by the investigator, using Sabbagh method. Exclusion Criteria: Presence of a medical condition that may put the participant at increased risk with exposure to onabotulinumtoxinA, including diagnosed muscular dystrophy (e.g., Duchenne's muscular dystrophy), myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, mitochondrial disease, or any other significant disease which might interfere with neuromuscular function. Presence or history of any of the following within 3 months prior to the randomization visit that may indicate a vulnerable respiratory state per the investigator's clinical judgment, for example, aspiration pneumonia, lower respiratory tract infections, uncontrolled asthma, severe chronic obstructive pulmonary disease, or otherwise compromised respiratory function. History of ongoing or anticipated need to perform progressive preoperative pneumoperitoneum or other tissue expansion technique for repair of ventral hernia. Planned ostomy reversal, panniculectomy bariatric procedure, or vascular procedure requiring anticoagulants during the study. History of abdominal or hernia repair surgery requiring hospitalization within 6 months prior to screening. History of a contraindication to BOTOX and/or hypersensitivity reactions to BOTOX.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
NYU Langone Hospital-Long Island /ID# 251280
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Atrium Health Carolinas Medical Center /ID# 247711
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.rxabbvie.com/
Description
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

Learn more about this trial

A Study to Evaluate Adverse Events and Effectiveness of OnabotulinumtoxinA in Participants Undergoing Open Abdominal Ventral Hernia Repair for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique

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