AdhesionsPhase 1NCT04100447
A Study to Evaluate the Safety, Tolerability and Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection
A Phase 1 study testing Tranexamic Acid in people with Adhesions and Ileus, run by Ronald Hurst, MD, FACS at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Tranexamic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2018to 1 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- History of or current seizure disorder.
- Subjects with myeloproliferative disorders.
- Subjects with a Body Mass Index (BMI) > 40.
- 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.
- Planned treatment with alvimopan (Entereg®) during study participation period.
- Subjects who have received any other investigational therapy within 4 weeks.
- 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.
- 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.
- Subjects with a known history of radiation enteritis.
Trial locations and contacts
1 site in 1 country.
United States1 site
Centinela Hospital Medical Center
Inglewood, California, 90301
About this study
Official title: An Investigator-Sponsored, Open-Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection
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).
Read the detailed description
The intestinal mucosal barrier plays a key role in both acute critical care medical conditions as well as burdensome chronic diseases. Healthy maintenance of the intestinal mucosal barrier requires oxygenation and blood flow and avoidance of mechanical or physical injury. Potent digestive enzymes are maintained within the intestine as long as normal blood flow continues and no damage or disturbances to the wall occur.
Breakdown of the intestinal mucosal barrier can be produced by wide variety of events. These include prolonged low blood pressure (e.g. during shock), disruption of blood flow (e.g. during ischemia), and physical and mechanical perturbations (e.g. during trauma or abdominal surgery).
One of the key advances toward the use of LB1148 to reduce postoperative complications was the learning that with more subtle perturbations of the mucosal barriers, such as during abdominal surgery, intraluminal pancreatic digestive enzymes played a role in GI dysfunction. Perioperative oral administration of LB1148 in preclinical models was sufficient to reduce the delayed return of GI function. Furthermore, the reduction in pancreatic digestive enzyme-induced tissue damage resulted in a profound reduction in postoperative adhesion formation. Together, these preclinical studies provide evidence that blocking pancreatic digestive enzymes with LB1148 in the intestine reduces local tissue damage, preserves GI function, and reduces adhesion formation.
- Being tested
- Tranexamic Acid
- Keywords
- post-operative, abdominal
- Medical subject headings
- Tissue Adhesions, Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tranexamic AcidDrug
Also called LB1148
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | All subjects will receive 1 dose of study drug (split into 2 administrations), over the 12 hours prior to surgery. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From first study drug dosing through Day 30
Secondary outcomes (9)
Number of participants who require a nasogastric (NG) tube placement
Necessity for nasogastric (NG) tube placement
Measured: During hospitalization (up to 14 days postoperatively), yes or no
Average length of time an NG tube was in place, if required
Time NG tube was in place, if needed
Measured: During hospitalization (up to 14 days postoperatively), in hours
Number of participants who experience post surgical vomiting
Presence of postsurgical vomiting
Measured: During hospitalization (from surgical closure to up to 14 days postoperatively), yes or no
Average number of vomiting episodes, when present
Number of vomiting episode(s)
Measured: During hospitalization (from surgical closure to up to 14 days postoperatively), number of total episodes
Average time to first flatus following surgery
Time to first flatus
Measured: During hospitalization (from surgical closure to up to 14 days postoperatively), in hours
Average time to first bowel movement following surgery
Time to first bowel movement
Measured: During hospitalization (from surgical closure to up to 14 days postoperatively), in hours
Average time to tolerate a liquid diet following surgery
Time to toleration of a liquid diet
Measured: During hospitalization (from surgical closure to up to 14 days postoperatively), in hours
Average time to tolerate a solid diet after surgery
Time to toleration of a solid diet
Measured: During hospitalization (from surgical closure to up to 14 days postoperatively), in hours
Average time to hospital discharge order
Time to hospital discharge order written
Measured: During hospitalization (from admission to up to 14 days postoperatively), in hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start5 Nov 2018
- Primary completion20 Mar 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdhesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ronald Hurst, MD, FACS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ronald Hurst, MD, FACS, Centinela Hospital Medical Center
- Investigators
- Ronald Hurst, MD, Principal investigator, Centinela Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100447
- Sponsor's protocol ID
- LBS-IST-POI-101
- Status last verified
- Dec 2020
- First submitted
- 23 Aug 2019
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Sponsored, Open-Label Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of LB1148 for Subjects Undergoing Elective Bowel Resection
- ClinicalTrials.gov ID
- NCT04100447
- Acronym / sponsor ID
- LBS-IST-POI-101
- Keywords
- post-operative, abdominal
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Ronald Hurst, MD, FACSUniversity, hospital or other
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 20 Mar 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The intestinal mucosal barrier plays a key role in both acute critical care medical conditions as well as burdensome chronic diseases. Healthy maintenance of the intestinal mucosal barrier requires oxygenation and blood flow and avoidance of mechanical or physical injury. Potent digestive enzymes are maintained within the intestine as long as normal blood flow continues and no damage or disturbances to the wall occur.
Breakdown of the intestinal mucosal barrier can be produced by wide variety of events. These include prolonged low blood pressure (e.g. during shock), disruption of blood flow (e.g. during ischemia), and physical and mechanical perturbations (e.g. during trauma or abdominal surgery).
One of the key advances toward the use of LB1148 to reduce postoperative complications was the learning that with more subtle perturbations of the mucosal barriers, such as during abdominal surgery, intraluminal pancreatic digestive enzymes played a role in GI dysfunction. Perioperative oral administration of LB1148 in preclinical models was sufficient to reduce the delayed return of GI function. Furthermore, the reduction in pancreatic digestive enzyme-induced tissue damage resulted in a profound reduction in postoperative adhesion formation. Together, these preclinical studies provide evidence that blocking pancreatic digestive enzymes with LB1148 in the intestine reduces local tissue damage, preserves GI function, and reduces adhesion formation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Tranexamic AcidAll subjects will receive 1 dose of study drug (split into 2 administrations), over the 12 hours prior to surgery. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will be eligible for participation in the study only if they meet ALL of the following inclusion criteria:
Key exclusion criteria (34 listed)
- Subjects will not be eligible for participation in the study if they meet ANY of the following exclusion criteria:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tranexamic AcidAlso: LB1148A 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. | Drug | Treatment Arm |
Primary outcome
The number of participants who experience treatment-emergent adverse events (TEAEs)
Time frame: From first study drug dosing through Day 30
The number of participants who experience treatment-emergent adverse events (TEAEs) with Investigator-specified relationship to LB1148 and assessment of severity
9 secondary outcomes
Number of participants who require a nasogastric (NG) tube placement
Time frame: During hospitalization (up to 14 days postoperatively), yes or no
Average length of time an NG tube was in place, if required
Time frame: During hospitalization (up to 14 days postoperatively), in hours
Number of participants who experience post surgical vomiting
Time frame: During hospitalization (from surgical closure to up to 14 days postoperatively), yes or no
Average number of vomiting episodes, when present
Time frame: During hospitalization (from surgical closure to up to 14 days postoperatively), number of total episodes
Average time to first flatus following surgery
Time frame: During hospitalization (from surgical closure to up to 14 days postoperatively), in hours
Average time to first bowel movement following surgery
Time frame: During hospitalization (from surgical closure to up to 14 days postoperatively), in hours
Average time to tolerate a liquid diet following surgery
Time frame: During hospitalization (from surgical closure to up to 14 days postoperatively), in hours
Average time to tolerate a solid diet after surgery
Time frame: During hospitalization (from surgical closure to up to 14 days postoperatively), in hours
Average time to hospital discharge order
Time frame: During hospitalization (from admission to up to 14 days postoperatively), in hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ronald Hurst, MD principal investigator
Centinela Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tranexamic Acid in people with Adhesions and Ileus, run by Ronald Hurst, MD, FACS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants who experience treatment-emergent adverse events (TEAEs) (time frame: From first study drug dosing through Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2020.