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

• Status: Completed
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ronald Hurst, MD, FACS
• Treatments: Tranexamic Acid

Criteria

Inclusion Criteria:

• Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:

1. 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.

2. The subject has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent.

Exclusion Criteria:

• Subjects will not be eligible for participation in the study if they meet ANY of the following exclusion criteria:

1. Subjects who are < 18 or > 85 years of age.

2. Subjects who require emergency bowel surgery.

3. 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.

4. Subjects who meet the American Society of Anesthesiologists (ASA) definition for Class 4 or 5 disease.

5. Known inability to take the study drug orally (i.e. complete small bowel obstruction).

6. Subjects with contraindications or potential risk factors to taking TXA. These include:

1. Known sensitivity to TXA

2. Recent craniotomy (past 30 days)

3. Active cerebrovascular bleed

4. Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism, cerebral thrombosis, ischemic stroke, or acute coronary syndrome)

5. Acute promyelocytic leukemia taking all-trans retinoic acid for remission induction

6. Continuing use of a combined hormonal contraceptive and/or combined hormonal replacement therapy (including combined hormonal pill, patch, or vaginal ring).

7. Subjects who have the following risk factors for thromboembolic disease:

1. 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

2. Neurologic paresis, partial paralysis, or paralysis

3. Presence of a pacemaker

4. History of pulmonary embolism, deep vein thrombosis, cerebrovascular accident, or retinal venous/arterial occlusion.

8. History of or current seizure disorder.

9. Subjects with myeloproliferative disorders.

10. Subjects with a Body Mass Index (BMI) > 40.

11. Any other condition that, in the opinion of the Investigator, would preclude the subject from being an appropriate candidate for the study, including severe renal or hepatic impairment.

12. Planned treatment with alvimopan (Entereg®) during study participation period.

13. Subjects who have received any other investigational therapy within 4 weeks.

14. Subjects with a history of chronic opioid usage, defined by the American Pain Society as daily or near-daily use of opioids for at least 90 days.

15. Female subjects of childbearing potential with a positive urine or serum pregnancy test or who are not taking (or not willing to take) acceptable birth control measures (abstinence, intrauterine device, contraceptive implant or barrier method) through Study Day 30. Additionally, those women who are lactating and insist on breast feeding within 5 days of the last dose of study drug, are excluded.

16. Subjects with a known history of radiation enteritis.