Ventral Hernia
Conditions
Keywords
Ventral Hernia, AGN-151607-DP, Primary fascial closure, Open Abdominal Ventral Hernia Repair
Brief summary
A ventral hernia happens when the muscles in the front of your belly become weak and let organs push through, causing a bulge. If it gets worse, intestines can slip into the bulge, leading to serious pain and health problems. This study aims to asses if AGN-151607-DP is safe and effective for closing the belly wall after open ventral hernia surgery, without needing a complex procedure. Adverse Events and change in disease activity will be assessed. AGN-151607-DP is an investigational drug being developed to treat ventral hernia. Participants will be randomly placed in treatment groups to receive either AGN151607-DP or matching placebo. Approximately 200 adult participants with midline ventral hernia needing open surgical repair will be enrolled in approximately 30 sites in the United States. Participants will receive intramuscular injections of AGN-161607-DP or matching placebo on Day 1. Duration of the study is approximately 25 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Interventions
DRUGAGN-151607-DP
Intramuscular Injection
Intramuscular Injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
\- Midline ventral hernia requiring open surgical repair.
Exclusion criteria
* Medical condition that may put the participant at increased risk with exposure to AGN-151607-DP, 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. * History of abdominal or hernia repair surgery requiring hospitalization within 6 months prior to screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Primary Fascial Closure (PFC) Without Use of Component Separation Technique (CST) in Open Ventral Hernia Surgical Repair | Up to approximately 1 Month | PFC will be defined as the ability to achieve fascia to fascia midline approximation. |
| Percentage of Participants Experiencing Adverse Events | Up to approximately 25 Months | An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving PFC | Up to approximately 1 Month | 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 | Up to approximately 1 Month | Percentage of participants with usage of CST will be assessed. |
| Number of Lateral Abdominal Wall Muscles Released to Achieve PFC | Up to approximately 1 Month | Number of lateral abdominal wall muscles released to achieve PFC will be assessed. |
| Change From Baseline in Length of Lateral Abdominal Wall Complex as Measured by Abdominal CT Scan in Supine Position Prior to Surgical Repair | Up to approximately 1 Month | Change in length of lateral abdominal wall complex will be assessed. |
| Change From Baseline in Length of Lateral Abdominal Wall Complex as Measured by Abdominal CT Scan Performing Valsalva Maneuver Prior to Surgical Repair | Up to approximately 1 Month | Change in length of lateral abdominal wall complex will be assessed. |
| Change From Baseline in Width to the Hernia Defect as Measured by Abdominal CT Scan in Supine Position Prior to Surgical Repair | Up to approximately 1 Month | Change in width to the hernia defect will be assessed. |
| Change From Baseline in Width to the Hernia Defect as Measured by Abdominal CT Scan Performing Valsalva Maneuver Prior to Surgical Repair | Up to approximately 1 Month | Change in width to the hernia defect will be assessed. |
Countries
United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed