A Phase 2 interventional study of BOTOX Dose A and Placebo for BOTOX in Ventral Hernia and Abdominal Hernia, sponsored by AbbVie. Withdrawn at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by AbbVie · Phase 2, Interventional, and Treatment
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.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
Browse Hernia, Ventral studies →AbbVie is the lead sponsor of 973 studies on the registry; 133 are open to participants now.
Of its 357 completed or terminated interventional studies of FDA-regulated products, 214 (60%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participant meets the following disease activity criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive BOTOX Dose A
Drug: BOTOX Dose A
Participants will receive BOTOX Dose B.
Drug: BOTOX Dose B
Participants will receive placebo for BOTOX.
Drug: Placebo for BOTOX
Participants will receive BOTOX Dose A
Drug: BOTOX Dose A
Participants will receive BOTOX Dose B
Drug: BOTOX Dose B
Participants will receive BOTOX Dose C
Drug: BOTOX Dose C
Participants will receive placebo for BOTOX
Drug: Placebo for BOTOX
Participants will receive BOTOX Dose A
Drug: BOTOX Dose A
Participants will receive BOTOX Dose B.
Drug: BOTOX Dose B
Participants will receive BOTOX Dose C.
Drug: BOTOX Dose C
Participants will receive placebo for BOTOX.
Drug: Placebo for BOTOX
Injection; intramuscular
Also known as: OnabotulinumtoxinA
Placebo
Injection; intramuscular
Also known as: OnabotulinumtoxinA
Injection; intramuscular
Also known as: OnabotulinumtoxinA
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).
Time frame: Up to 4 Months
Percentage of participants with achievement of PFC
PFC will be defined as the ability to achieve fascia to fascia midline approximation.
Time frame: Up to 4 Months
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).
Time frame: Up to 4 Months
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)
Time frame: Up to 4 Months
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.
Time frame: Up to 4 Months
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.
Time frame: Up to 4 Months
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.
Time frame: Up to 4 Months
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
Time frame: Up to 4 Months
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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/
Data sharing details ↗ · vivli.org
Start is estimated for May 2024; primary completion for Apr 2025, 11 months later.
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This study is withdrawn, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A