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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AGN-151607-DP Dose A | Experimental | Participants will receive AGN-151607-DP Dose A on Day 1. |
|
| AGN-151607-DP Dose B | Experimental | Participants will receive AGN-151607-DP Dose B on Day 1. |
|
| AGN-151607-DP Dose C | Experimental | Participants will receive AGN-151607-DP Dose C on Day 1. |
|
| Placebo for AGN-151607-DP | Placebo Comparator | Participants will receive Placebo for AGN-151607-DP on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-151607-DP | Drug | Intramuscular Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Primary Fascial Closure (PFC) Without Use of Component Separation Technique (CST) in Open Ventral Hernia Surgical Repair | PFC will be defined as the ability to achieve fascia to fascia midline approximation. | Up to approximately 1 Month |
| Percentage of Participants Experiencing Adverse Events | 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. | Up to approximately 25 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving PFC | PFC will be defined as the ability to achieve fascia to fascia midline approximation. | Up to approximately 1 Month |
| Percentage of Participants With Usage of CST for the Purpose of PFC |
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Inclusion Criteria:
- Midline ventral hernia requiring open surgical repair.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ABBVIE CALL CENTER | Contact | 844-663-3742 | abbvieclinicaltrials@abbvie.com |
| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CARI Clinical Trials INC /ID# 278844 | Recruiting | Riverside | California | 92504 | United States | |
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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| Placebo for AGN-151607-DP | Drug | Intramuscular Injection |
|
Percentage of participants with usage of CST will be assessed.
| Up to approximately 1 Month |
| Number of Lateral Abdominal Wall Muscles Released to Achieve PFC | Number of lateral abdominal wall muscles released to achieve PFC will be assessed. | Up to approximately 1 Month |
| Change From Baseline in Length of Lateral Abdominal Wall Complex as Measured by Abdominal CT Scan in Supine Position Prior to Surgical Repair | Change in length of lateral abdominal wall complex will be assessed. | Up to approximately 1 Month |
| Change From Baseline in Length of Lateral Abdominal Wall Complex as Measured by Abdominal CT Scan Performing Valsalva Maneuver Prior to Surgical Repair | Change in length of lateral abdominal wall complex will be assessed. | Up to approximately 1 Month |
| Change From Baseline in Width to the Hernia Defect as Measured by Abdominal CT Scan in Supine Position Prior to Surgical Repair | Change in width to the hernia defect will be assessed. | Up to approximately 1 Month |
| Change From Baseline in Width to the Hernia Defect as Measured by Abdominal CT Scan Performing Valsalva Maneuver Prior to Surgical Repair | Change in width to the hernia defect will be assessed. | Up to approximately 1 Month |
| University of Florida - Jacksonville /ID# 261992 |
| Recruiting |
| Jacksonville |
| Florida |
| 32209 |
| United States |
| Medical Research Center /ID# 278680 | Recruiting | Miami | Florida | 33144 | United States |
| Avanza Medical Research Center /ID# 278885 | Recruiting | Pensacola | Florida | 32503 | United States |
| NorthShore University-Endeavor Health Evanston Hospital /ID# 277995 | Recruiting | Evanston | Illinois | 60201 | United States |
| Integrity Clinical Research /ID# 278710 | Completed | Wichita | Kansas | 67202 | United States |
| Novant Health New Hanover Regional Medical Center /ID# 261979 | Recruiting | Wilmington | North Carolina | 28401-7407 | United States |
|
| Cleveland Clinic - Cleveland /ID# 277914 | Recruiting | Cleveland | Ohio | 44195 | United States |
| Prisma Health Greenville Memorial Hospital /ID# 261995 | Recruiting | Greenville | South Carolina | 29605-4210 | United States |
| Baylor University Medical Center /ID# 261955 | Recruiting | Dallas | Texas | 75246 | United States |
| Carilion Roanoke Memorial Hospital /ID# 278577 | Recruiting | Roanoke | Virginia | 24014 | United States |
| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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