A Study to Evaluate the Safety, Tolerability and Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection

Completed · Phase 1

Conditions studied: Adhesions, Ileus

In brief

The purpose of this study is to assess the safety, tolerability, and preliminary efficacy of LB1148 in subjects undergoing elective bowel resection. During abdominal surgery, surgeons handle, manipulate, and often make incisions in the bowel. These actions can create bruising, lesions, and microscopic damage to the bowel, which may allow digestive enzymes to cross the intestinal mucosal barrier potentially resulting in injury both locally and remotely. Leaking digestive enzymes may delay return of normal gastrointestinal (GI) function, lead to a lack of motility in the intestine (ileus), and promote the formation of intestinal scar tissue (adhesions).

Key facts

Study ID

NCT04100447

Run by

Ronald Hurst, MD, FACS

People needed

11

Starts

2018-11-05

Expected to finish

2020-12-01

Last updated by the study team

2020-12-04

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:
• Scheduled to undergo an elective (non-emergent) bowel resection. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elected indication.
• The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

You may not qualify if…

• Subjects will not be eligible for participation in the study if they meet ANY of the following exclusion criteria:
• Subjects who are < 18 or > 85 years of age.
• Subjects who require emergency bowel surgery.
• Subjects who have had 2 or more abdominal surgeries, excluding the current, for inflammatory bowel disease (IBD), including, but not limited to, IBD, Crohn's Disease, or ulcerative colitis. Note: This does not apply to previous surgeries such as hernia repair unrelated to IBD.
• Subjects who meet the American Society of Anesthesiologists (ASA) definition for Class 4 or 5 disease.
• Known inability to take the study drug orally (i.e. complete small bowel obstruction).
• Subjects with contraindications or potential risk factors to taking TXA. These include:
• Known sensitivity to TXA
• Recent craniotomy (past 30 days)
• Active cerebrovascular bleed
• Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome)
• Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction
• Continuing use of a combined hormonal contraceptive and/or combined hormonal replacement therapy (including combined hormonal pill, patch, or vaginal ring).
• Subjects who have the following risk factors for thromboembolic disease:
• Known medical history of congenital or acquired thrombophilia such as, but not limited to:
• Sickle cell disease
• Nephrotic syndrome
• Factor V Leiden
• Prothrombin gene mutation
• Protein C or S deficiency
• Antithrombin III deficiency
• Antiphospholipid syndrome
• Neurologic paresis, partial paralysis, or paralysis
• Presence of a pacemaker
• History of pulmonary embolism, deep vein thrombosis, cerebrovascular accident, or retinal venous/arterial occlusion.

Where it is running

• Centinela Hospital Medical Center — Inglewood, California, United States

Full record on ClinicalTrials.gov

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