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

NCT04100447 | Completed Phase 1 FDA Drug

• 1 other identifier: LBS-IST-POI-101
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Adhesions; Ileus

Keywords

post-operative; abdominal

Outcome Measures

Primary Outcomes (1)

• The number of participants who experience treatment-emergent adverse events (TEAEs)

  The number of participants who experience treatment-emergent adverse events (TEAEs) with Investigator-specified relationship to LB1148 and assessment of severity

  From first study drug dosing through Day 30

Secondary Outcomes (9)

• Number of participants who require a nasogastric (NG) tube placement

  During hospitalization (up to 14 days postoperatively), yes or no

• Average length of time an NG tube was in place, if required

  During hospitalization (up to 14 days postoperatively), in hours

• Number of participants who experience post surgical vomiting

  During hospitalization (from surgical closure to up to 14 days postoperatively), yes or no

• Average number of vomiting episodes, when present

  During hospitalization (from surgical closure to up to 14 days postoperatively), number of total episodes

• Average time to first flatus following surgery

  During hospitalization (from surgical closure to up to 14 days postoperatively), in hours

Study Arms (1)

Treatment Arm

EXPERIMENTAL

All subjects will receive 1 dose of study drug (split into 2 administrations), over the 12 hours prior to surgery.

Drug: Tranexamic Acid

Interventions

Tranexamic Acid DRUG

A total of 700 mL of study drug should be completely consumed orally 2-12 hours prior to surgery as a split dose; 350 mL 6-12 hours prior to surgery and the remaining 350 mL 2-6 hours prior to surgery.

Also known as: LB1148

Treatment Arm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

Sponsors & Collaborators

• Ronald Hurst, MD, FACS: lead

Study Sites (1)

Centinela Hospital Medical Center

Inglewood, California, 90301, United States

Location

MeSH Terms

Conditions

Tissue Adhesions; Ileus

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Ronald Hurst, MD

  Centinela Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is an investigator-initiated, open label, Phase 1 study to evaluate LB1148 for safety, tolerability, and preliminary efficacy in subjects undergoing elective bowel resection. All subjects will receive LB1148 prior to surgery.

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: September 24, 2019
• Study Start: November 5, 2018
• Primary Completion: March 20, 2020
• Study Completion: December 1, 2020
• Last Updated: December 4, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)