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NCT07226791ClinicalTrials.gov

Study of AGN-151607-DP to Assess Adverse Events and Change in Disease Activity in Adult Participants Undergoing Open Abdominal Ventral Hernia Repair

A Phase 2 Double-Blind, Placebo-Controlled, Adaptive, Dose-Escalation Study to Evaluate the Safety and Efficacy of AGN-151607-DP (USAN: gemibotulinumtoxinA) for the Achievement of Primary Fascial Closure Without the Use of Component Separation Technique, in Subjects Undergoing Open Abdominal Ventral Hernia Repair

قيد التجنيديقبل مشاركين الآن، وفقاً لسجل السجل.
التواصل مع هذه الدراسة

باختصار

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…

المرحلة 2مطلوب 200 مشارك13 موقعاًدولة واحدة

مسجَّلة في سجل واحد

يمكن أن تُسجَّل دراسة واحدة في عدة سجلات. نعرضها مرة واحدة ونربط بكل سجل نحتفظ به.

تُعرض معلومات التجربة كما نشرها السجل، بلغتها الأصلية.

هل أنت مهتم بهذه الدراسة؟

تسجيل الدخول أو أنشئ حسابًا لتسجيل اهتمامك ومتابعة هذه الدراسة.

How this study is set up

The points below are drawn from the public registry record for this study. Each one cites the field or sentence it came from. A dash (—) means the record does not state something — not that it is missing or wrong. Many well-run studies, especially small ones, leave some of these blank.

  • Registered before enrolment beganFirst posted 2025-11-10; recorded start 2026-02-04
  • Has a defined primary outcomeA primary outcome measure is listed in the record
  • The primary outcome states a time frameThe primary outcome measure records a time frame
  • Participants are randomly assignedAllocation is recorded as randomised
  • Has a comparison groupThe record lists a placebo or comparator arm, or more than one study arm
  • Uses blinding (masking)A masking level is recorded in the record
  • An ethics committee is not stated in the registry recordThis registry's ingested record has no ethics-committee field
  • Regulatory oversight (such as an IND or IDE) is not stated in the registry recordThis registry's ingested record has no regulatory-authorisation field
  • A data monitoring committee is not stated in the registry recordThis registry's ingested record has no data-monitoring-committee fieldA data monitoring committee is not required for many smaller studies, and its absence here is not unusual.
  • No cost to participants is mentioned in the recordChecked the summary, description and eligibility text; no cost-to-participant phrase found
  • Sponsor has 378 other studies in this databaseCounted from the lead sponsor named in the record (AbbVie)
  • Sponsor has posted results for at least one studyBased on the sponsor’s studies in this database
  • The record lists 1 condition.
  • Lead sponsor type recorded as: industry.
  • Intervention regulatory context: investigational, within a phased regulatory pathway.

These are facts from the public registry record, not a judgement about the study. Discuss any trial with your own doctor before taking part.

What these facts mean, and what to ask · ruleset v1

Trial stature

Three independent measures of this study, described from its registry record — not a recommendation about it. A rigorous study by investigators nobody has heard of is better evidence than a weak study led by a famous one. How these are scored.

Methodological rigourDEFINITIVE

A definitive-grade design for a phase 2 study, judged from its ClinicalTrials.gov record.

How this score is built
  • Randomised allocation20/20

    Participants are randomly allocated between arms

  • Blinding20/20

    Quadruple-blind

  • Control arm13/15

    Placebo / sham control arm

  • Primary-outcome specificity10/10

    Named primary outcome with a defined time frame

  • Endpoint type3/10

    Surrogate or intermediate endpoint (conservative default)

  • Multi-centre8/8

    Multi-centre: 12 sites

  • Data monitoring committee7/7

    A data monitoring committee is in place

  • Prospective registration5/5

    Registered before the study start date

  • Protocol / SAP posted0/5

    No protocol or SAP posted to the registry

ScaleMEDIUM

A medium-sized study: 200 participants (target), run at 13 sites.

How this score is built
  • Enrolment22/40

    200 participants (target)

  • Site count13/25

    12 sites

  • Country count0/15

    Single country

  • Planned duration9/10

    Planned over about 52 months

  • Sponsor scale9/10

    AbbVie has led 364 trials in our corpus

Investigator standingUNKNOWN

We have no verifiable track record for the investigator named on this trial. That is common for early-career investigators and for records held outside ClinicalTrials.gov — it is not a negative signal.

How this score is built
  • Investigator standing0/100

    No investigator recorded in the registry for this trial

These describe the registry record only, and today we hold ClinicalTrials.gov data. Absent fields lower a score, and absence often reflects registration practice rather than study quality. A high-stature trial is not necessarily safer or a better choice for you — enrolling in a large definitive trial can mean a higher chance of receiving placebo, while a small early-phase study may be the only route to a new therapy.

ملخص

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.

الحالات

  • Ventral Hernia

الأهلية

الجنسالجميع
الأعمار18 Years – 80 Years
المتطوعون الأصحّاءلا

الأهلية كما كُتبت في السجل

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.

الأهلية في عبارات بسيطة

لم تُقسَّم معايير هذا السجل إلى عبارات منفصلة بعد. نص السجل أعلاه كامل وهو النسخة المُعتمَدة.

تصميم الدراسة

نوع الدراسةتدخّلية
المرحلةالمرحلة 2
التخصيصمعشّاة
نموذج التدخّلSEQUENTIAL
الغرض الأساسيTREATMENT
التعميةQUADRUPLE (4)
التجنيدمطلوب 200 مشارك

الجهة الراعية والمتعاونون

  • AbbVie الجهة الراعية

الأذرع والتدخلات

  • AGN-151607-DP Dose AEXPERIMENTAL

    Participants will receive AGN-151607-DP Dose A on Day 1.

  • AGN-151607-DP Dose BEXPERIMENTAL

    Participants will receive AGN-151607-DP Dose B on Day 1.

  • AGN-151607-DP Dose CEXPERIMENTAL

    Participants will receive AGN-151607-DP Dose C on Day 1.

  • Placebo for AGN-151607-DPPLACEBO_COMPARATOR

    Participants will receive Placebo for AGN-151607-DP on Day 1.

التدخلات

  • دواء AGN-151607-DP

    Intramuscular Injection

  • دواء Placebo for AGN-151607-DP

    Intramuscular Injection

مقاييس النتائج

  1. مقياس النتيجة الأولي

    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.

    الإطار الزمني Up to approximately 1 Month

  2. مقياس النتيجة الأولي

    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.

    الإطار الزمني Up to approximately 25 Months

  3. مقياس النتيجة الثانوي

    Percentage of Participants Achieving PFC

    PFC will be defined as the ability to achieve fascia to fascia midline approximation.

    الإطار الزمني Up to approximately 1 Month

  4. مقياس النتيجة الثانوي

    Percentage of Participants With Usage of CST for the Purpose of PFC

    Percentage of participants with usage of CST will be assessed.

    الإطار الزمني Up to approximately 1 Month

  5. مقياس النتيجة الثانوي

    Number of Lateral Abdominal Wall Muscles Released to Achieve PFC

    Number of lateral abdominal wall muscles released to achieve PFC will be assessed.

    الإطار الزمني Up to approximately 1 Month

  6. مقياس النتيجة الثانوي

    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.

    الإطار الزمني Up to approximately 1 Month

  7. مقياس النتيجة الثانوي

    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.

    الإطار الزمني Up to approximately 1 Month

  8. مقياس النتيجة الثانوي

    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.

    الإطار الزمني Up to approximately 1 Month

  9. مقياس النتيجة الثانوي

    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.

    الإطار الزمني Up to approximately 1 Month

التواريخ

تاريخ البدء4 فبراير 2026 (فعلي)
الإتمام الأولي1 سبتمبر 2028 (تقديري)
الإتمام1 مايو 2030 (تقديري)
أول نشر10 نوفمبر 2025 (فعلي)
آخر تحديث25 أغسطس 2026
النتائج منشورةغير مذكور في سجل السجل
آخر تأكيد للحالةأغسطس 2026

فعلي يعني أن الحدث وقع. تقديري يعني أن الجهة الراعية تتوقعه. للكلمتين معنيان مختلفان.

المواقع

11 موقعاً قيد التجنيد

United States

المنشأةالمدينةالولاية أو المنطقةالحالة
Cleveland Clinic - Cleveland /ID# 277914ClevelandOhioقيد التجنيد
Baylor University Medical Center /ID# 261955DallasTexasقيد التجنيد
NorthShore University-Endeavor Health Evanston Hospital /ID# 277995EvanstonIllinoisقيد التجنيد
Prisma Health Greenville Memorial Hospital /ID# 261995GreenvilleSouth Carolinaقيد التجنيد
Penn State Milton S. Hershey Medical Center /ID# 261987HersheyPennsylvaniaقيد التجنيد
University of Florida - Jacksonville /ID# 261992JacksonvilleFloridaمكتمل
Medical Research Center /ID# 278680MiamiFloridaقيد التجنيد
Avanza Medical Research Center /ID# 278885PensacolaFloridaقيد التجنيد
CARI Clinical Trials INC /ID# 278844RiversideCaliforniaقيد التجنيد
Carilion Roanoke Memorial Hospital /ID# 278577RoanokeVirginiaقيد التجنيد
Mayo Clinic Hospital Rochester /ID# 278995RochesterMinnesotaقيد التجنيد
Integrity Clinical Research /ID# 278710WichitaKansasمكتمل
Novant Health New Hanover Regional Medical Center /ID# 261979WilmingtonNorth Carolinaقيد التجنيد

مستندات الدراسة

لا تُرتبط أي مستندات في سجل السجل هذا.

التغيّرات عبر الزمن

  1. 25 أغسطس 2026

    أُضيف موقع

    1 site added (13 total)

    1213

السجل: ClinicalTrials.gov · NCT########

https://xmedica.io/trials/ctgov/NCT07226791