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Anti-Adhesion Product

Phase 2

Intraperitoneal Adhesions | Monoclonal antibody | Other |Baxter International Inc.|Last Updated: Aug 4, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindNO_TREATMENT_CONTROLLEDDMC
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

Anti-Adhesion Product · 1 trial · 1 indication

Phase 2 1
NCT00512356Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal AdhesionsIntraperitoneal Adhesions
COMPLETED46 Analytics
PHASE2COMPLETED
Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions
Intraperitoneal AdhesionsUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adhesions around the rectal stump and/or incision line

Secondary Endpoints

Number of subjects with no adhesions
Extent and severity of adhesions around the rectal stump
Extent and severity of adhesions at the incision line
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Investigational product groupEXPERIMENTALAnti-Adhesion Product was applied to the rectal stump and the incision line. Like in the control group, surgical measures to prevent adhesions were also taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves.
Control groupNO_INTERVENTIONOnly surgical measures to prevent adhesions were taken, e.g. using minimum traumatizing surgical technique, using powder-free gloves. No specific additional treatment was applied.

Interventions

NameTypeDescription
Anti-Adhesion ProductBIOLOGICALAnti-Adhesion Product (AAP) is a biological two-component product of human origin. The components of AAP are lyophilized Anti-Adhesion Protein Concentrate (AAPC), containing fibrinogen, lyophilized Thrombin Concentrate (TC) and the respective diluents for the reconstitution of the components.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Written informed consent obtained from the subject or the subject's legally authorized representative prior to study entry * Male or female subjects \> 18 years of age * Subjects undergoing abdominal surgery with the possibility that a rectal stump would remain due to one or m...

Countries:DenmarkPolandSweden
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Frequently asked questions about Anti-Adhesion Product

What is Anti-Adhesion Product used for?

Anti-Adhesion Product is an investigational monoclonal antibody being studied for the prevention of intraperitoneal adhesions, which are fibrous bands that can form between abdominal tissues and organs after surgery. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

Who makes Anti-Adhesion Product?

Anti-Adhesion Product is being developed by Baxter International Inc., a company publicly traded under the ticker symbol BAX. The company is conducting clinical research to evaluate the safety and efficacy of this investigational product for the prevention of intraperitoneal adhesions.

What phase is Anti-Adhesion Product in?

Anti-Adhesion Product is in Phase 2 clinical development. It is an investigational product and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate its safety and efficacy in preventing intraperitoneal adhesions.

What clinical trials is Anti-Adhesion Product in?

Anti-Adhesion Product has one completed Phase 2 clinical trial registered as NCT00512356, titled 'Efficacy and Safety Study of Anti-Adhesion Product in the Prevention of Intraperitoneal Adhesions.' The trial enrolled 46 participants and was conducted in Denmark, Poland, and Sweden.

How does Anti-Adhesion Product work?

Anti-Adhesion Product is a monoclonal antibody, a type of biologic therapy that uses laboratory-made proteins to target specific molecules in the body. Its exact molecular target has not been disclosed, but it is being studied for its potential to prevent the formation of intraperitoneal adhesions.