Companion Protocol for the ¹³C-Methacetin Breath Test (MBT) for Use in Bristol-Myers Squibb Phase 2b Studies for BMS-986036 (PEG-FGF21), Under Studies Referenced in NCT03486899, NCT03486912

This is a companion study assessing the ¹³C-Methacetin Breath Test (MBT) in subjects participating in the Bristol Myers-Squibb (BMS) NCT03486899 and NCT03486912 referenced studies using study drug BMS-986036.

Start Date04 May 2018

Sponsor / Collaborator

Meridian Bioscience, Inc.

[+1]

NCT02786836 / CompletedPhase 2/3IIT

13C-Methacetin Breath Test for the Prediction of Outcome in in Acute Liver Injury or Acute Liver Failure

The ALFSG-MBT protocol is for a multicenter, open label, non-randomized study to determine the value of Breath Identification® (BreathID®) N-(4-Methoxy-13C-phenyl)acetamide (13C-Methacetin) Breath Test System in predicting the outcome of patients diagnosed with severe acute liver injury that is not related to acetaminophen overdose or acute liver failure who meet inclusion/exclusion criteria.
Up to 200 evaluable patients will be enrolled. An evaluable patient is one who has completed one or more breath tests for at least 30 minutes after administration of the 13C-Methacetin solution (test substrate).
The Breath Test will be performed up to five times during the study period on all enrolled patients. The first Breath Test will be performed upon admission into the study (Day 1) and repeated on Days 2, 3, 5 and 7 provided no contra-indications are present. Each test continuously measures changes in the metabolism of the 13C-Methacetin in order to assess the improvement or deterioration in liver metabolic function about improvement or deterioration in liver metabolic function. If an enrolled non-APAP ALI or ALF patient receives a liver transplant, is discharged /transferred from the hospital or dies prior to Day 7, additional Breath Tests will not be performed.
Patients will be contacted for the Day 21 follow up (21 days after enrollment into the trial) to determine spontaneous survival, transplantation and occurrence of serious adverse events since the patient's last study treatment.

Start Date10 Jun 2016

Sponsor / Collaborator

The University of Texas Southwestern Medical Center

[+4]

NCT02084160 / CompletedNot Applicable

The Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation; a Retrospective Analysis

The objectives of this study are:
To evaluate the ability of the Methacetin Breath Test (MBT) to detect hepatic decompensation events
To evaluate the relationship between liver Biopsy and clinical outcome and show that the MBT has a better predictive ability of clinical outcome than liver biopsy.
To evaluate the ability of the MBT to predict each of the individual liver related complications.

Start Date01 Mar 2014

Sponsor / Collaborator

Meridian Bioscience, Inc.

100 Clinical Results associated with 13C-Methacetin(University of Texas Southwestern Medical Center)

100 Translational Medicine associated with 13C-Methacetin(University of Texas Southwestern Medical Center)

100 Patents (Medical) associated with 13C-Methacetin(University of Texas Southwestern Medical Center)

Literatures (Medical) associated with 13C-Methacetin(University of Texas Southwestern Medical Center)

01 Oct 2024·BIOGEOCHEMISTRY

Delineating acetaminophen biodegradation kinetics and metabolomics using bacterial community

Article

Author: Dubey, Suresh Kumar ; Pandey, Bhavana

Acetaminophen [N-(4-hydroxyphenyl) acetamide, APAP] is an extensively and frequently consumed over-the-counter analgesic and antiphlogistic medication. It is being regarded as an emerging pollutant due to its continuous increment in the environment instigating inimical impacts on humans and the ecosystem. Considering its wide prevalence in the environment, there is an immense need of appropriate methods for the removal of APAP. The present study indulged screening and isolation of APAP degrading bacterial strains from pharmaceuticals-contaminated sites, followed by their molecular characterization via 16S rRNA sequencing. The phylogenetic analyses assigned the isolates to the genera Pseudomonas, Bacillus, Paracoccus, Agrobacterium, Brucella, Escherichia, and Enterobacter based on genetic relatedness. The efficacy of these strains in batch cultures tested through High-performance Liquid Chromatography (HPLC) revealed Paracoccus sp. and Enterobacter sp. as the most promising bacterial isolates degrading up to 88.96 and 85.92%, respectively of 300 mg L^-1 of APAP within 8 days of incubation. Michaelis-Menten kinetics model parameters also elucidated the high degradation potential of these isolates. The major metabolites identified through FTIR and GC-MS analyses were 4-aminophenol, hydroquinone, and 3-hydroxy-2,4-hexadienedioic. Therefore, the outcomes of this comprehensive investigation will be of paramount significance in formulating strategies for the bioremediation of acetaminophen-contaminated sites through a natural augmentation process via native bacterial strains.

01 Jan 2022·Dose-response : a publication of International Hormesis SocietyQ4 · MEDICINE

The Potential Protective Effect of Curcumin and α-Lipoic Acid on N-(4-Hydroxyphenyl) Acetamide-induced Hepatotoxicity Through Downregulation of α-SMA and Collagen III Expression

Q4 · MEDICINE

ArticleOA

Author: Ali, Hanaa ; Sarawi, Wedad ; Badr, Amira ; Mahamad, Raeesa ; Fadda, Laila ; Alhusain, Ahlam ; Hasan, Iman ; Alomar, Hatun

Background and objectives:

N-(4-hydroxyphenyl) acetamide (NHPA) is the most commonly used analgesic and antipyretic agent worldwide; however, it remains the leading cause of drug-induced acute liver failure. This study explored the potential impact of curcumin (Curc) and/or α-lipoic acid (Lip acid) on liver damage induced by NHPA overdose.

Materials and Methods:

Male Wistar rats were intoxicated with a single oral dose of NHPA (1000 mg/kg) and treated with Curc (200 mg/kg p. o.) and/or Lip acid (100 mg/kg i. p.). These treatments were given in 2 doses at 2 hours and 10 hours post-NHPA-administration. Animals were sacrificed 24 hours post-NHPA-administration.

Results:

Treatment with Curc and/or Lip acid showed effective reduction of NHPA-induced liver injury, demonstrated by reducing serum alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin, as well as hepatic nitric oxide and malondialdehyde. Curc and/or Lip acid treatments counteracted these changes. They also ameliorated NHPA-induced centrilobular hepatocellular necrosis, evidenced by histopathological examination. Moreover, Curc and Lip acid reduced the expression of alpha-smooth muscle actin and collagen III, upregulated by NHPA intoxication in response to oxidative stress and inflammation.

Discussion and Conclusion:

Curc and Lip acid can be considered as promising natural therapies against liver injury, induced by NHPA, through their antioxidant and antifibrotic actions.

01 Sep 2018·European radiologyQ2 · MEDICINE

Gd-EOB-DTPA-enhanced T1 relaxometry for assessment of liver function determined by real-time 13C-methacetin breath test

Q2 · MEDICINE

Article

Author: Poelsterl, Stefanie ; Fuhrmann, Irene ; Verloh, Niklas ; Nickel, Marcel D ; Stroszczynski, Christian ; Wiggermann, Philipp ; Dahlke, Marc H ; Fellner, Claudia ; Weigand, Kilian ; Haimerl, Michael

OBJECTIVES:

To determine whether liver function as determined by intravenous administration of ¹³C-methacetin and continuous real-time breath analysis can be estimated quantitatively from gadoxetic acid (Gd-EOB-DTPA)-enhanced magnetic resonance (MR) relaxometry.

METHODS:

Sixty-six patients underwent a ¹³C-methacetin breath test (¹³C-MBT) for evaluation of liver function and Gd-EOB-DTPA-enhanced T1-relaxometry at 3 T. A transverse 3D VIBE sequence with an inline T1 calculation based on variable flip angles was acquired prior to (T1 pre) and 20 min post-Gd-EOB-DTPA (T1 post) administration. The reduction rate of T1 relaxation time (rrT1) and T1 relaxation velocity index (∆R1) between pre- and post-contrast images was evaluated. ¹³C-MBT values were correlated with T1_post, ∆R1 and rrT1, providing an MRI-based estimated ¹³C-MBT value. The interobserver reliability was assessed by determining the intraclass correlation coefficient (ICC).

RESULTS:

Stratified by three different categories of ¹³C-MBT readouts, there was a constant increase of T1 post with increasing progression of diminished liver function (p ≤ 0.030) and a constant significant decrease of ∆R1 (p ≤ 0.025) and rrT1 (p < 0.018) with progression of liver damage as assessed by ¹³C-methacetin breath analysis. ICC for all T1 relaxation values and indices was excellent (> 0.88). A simple regression model showed a log-linear correlation of ¹³C-MBT values with T1_post (r = 0.57; p < 0.001), ∆R1 (r = 0.59; p < 0.001) and rrT1 (r = 0.70; p < 0.001).

CONCLUSION:

Liver function as determined using real-time ¹³C-methacetin breath analysis can be estimated quantitatively from Gd-EOB-DTPA-enhanced MR relaxometry.

KEY POINTS:

• Gd-EOB-DTPA-enhanced T1 relaxometry quantifies liver function • Gd-EOB-DTPA-enhanced MR relaxometry may provide parameters for assessing liver function before surgery • Gd-EOB-DTPA-enhanced MR relaxometry may be useful for monitoring liver disease progression • Gd-EOB-DTPA-enhanced MR relaxometry has the potential to become a novel liver function index.

News (Medical) associated with 13C-Methacetin(University of Texas Southwestern Medical Center)

05 Nov 2018

·www.globenewswire.com

Data Collected by Exalenz Bioscience in Galectin Therapeutics’ Phase 2 NASH-CX Trial of GR-MD-02 to Be Presented at AASLD Annual Meeting

NORCROSS, Ga., Nov. 05, 2018 (GLOBE NEWSWIRE) -- Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins, today announced that an abstract based on results obtained in Galectin Therapeutics’ NASH-CX Phase 2 Clinical Trial has been accepted for a poster presentation by Exalenz Bioscience at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases (AASLD) in San Francisco on November 9-13, 2018. The poster presentation is titled “The noninvasive point of care MBT accurately predicts decompensation events better than MELD in compensated (MELD<15) NASH cirrhotics” authored by Naga Chalasani, et al. The poster illustrates Exalenz Bioscience’s 13C-Methacetin Breath Test’s (MBT) ability to predict decompensation in compensated NASH cirrhotics. MBT was performed on 160 patients with compensated NASH cirrhosis (i.e. no prior variceal hemorrhage, ascites or hepatic encephalopathy) in Galectin Therapeutics’ NASH-CX Phase 2 Clinical Trial. All were followed prospectively for decompensation. The study showed that MBT, which measures liver function, strongly predicts liver decompensation in patients with compensated NASH cirrhosis. The data suggest that this non-invasive, valid, operator-independent, point-of-care tool is safe and may be a more effective clinical tool than instruments currently used to help identify patients at increased risk for hepatic decompensation. The poster itself will be released in accordance with AASLD’s policies. Saturday, November 10, 2018 at 2:00 p.m. PSTPoster Session IIMoscone Center, Hall C “The noninvasive point of care MBT accurately predicts decompensation events better than MELD in compensated (MELD<15) NASH cirrhotics.” N. Chalasani, et al. Abstract #1337 About NASH-CX Phase 2b Trial Galectin Therapeutics announced top-line results from its NASH-CX Phase 2 trial in December 2017. The Company is proceeding with plans for a Phase 3 clinical trial program with its galectin-3 inhibitor GR-MD-02 in NASH cirrhosis, incorporating advice and guidance obtained in a meeting with the FDA. Details of the Phase 3 clinical trial design, including projected timings and costs, will be announced once the planning phase has been completed and the Company has submitted a final clinical trial protocol with the FDA. About Galectin Therapeutics Galectin Therapeutics is dedicated to developing novel therapies to improve the lives of patients with chronic liver disease and cancer. Galectin’s lead drug (GR-MD-02) is a carbohydrate-based drug that inhibits the galectin-3 protein which is directly involved in multiple inflammatory, fibrotic, and malignant diseases. The lead development program is in non-alcoholic steatohepatitis (NASH) with cirrhosis, the most advanced form of NASH related fibrosis. This is the most common liver disease and one of the largest drug development opportunities available today. Additional development programs are in treatment of severe atopic dermatitis, moderate-to-severe plaque psoriasis, and in combination immunotherapy for advanced melanoma and other malignancies; advancement of these additional clinical programs is largely dependent on finding a suitable partner. Galectin seeks to leverage extensive scientific and development expertise as well as established relationships with external sources to achieve cost-effective and efficient development. Additional information is available at www.galectintherapeutics.com. About Exalenz BioscienceExalenz Bioscience develops and markets diagnostic tests and monitoring systems that use the breath to diagnose and help manage gastrointestinal and liver conditions. The company’s flagship BreathID® Hp offers the most efficient and accurate test for detection of H. pylori bacteria, associated with various illnesses including gastric cancer, and is already in use in over 400 U.S. medical centers and major labs across the country. The BreathID 13C-methacetin breath test (MBT) is a sensitive, noninvasive, point of care tool that measures the microsomal function of the liver. Exalenz holds regulatory approvals in Europe, the United States, China and Israel for H. pylori detection and is currently evaluating additional applications of the BreathID platform, including MBT in the detection of CSPH in patients with NASH. Additional information is available at www.exalenz.com. Contacts:Jack Callicutt, Chief Financial Officer(678) 620-3186ir@galectintherapeutics.com Media Contact: Gregory FCALeigh Minnier, Vice President610-228-2108leigh@gregoryfca.com

Immunotherapy

100 Deals associated with 13C-Methacetin(University of Texas Southwestern Medical Center)

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Indication	Highest Phase	Country/Location	Organization	Date
Chemical and Drug Induced Liver Injury	Phase 3	US	The University of Texas Southwestern Medical Center	10 Jun 2016
Chemical and Drug Induced Liver Injury	Phase 3	US	Meridian Bioscience, Inc.	10 Jun 2016
Liver Failure, Acute	Phase 3	US	The University of Texas Southwestern Medical Center	10 Jun 2016
Liver Failure, Acute	Phase 3	US	Meridian Bioscience, Inc.	10 Jun 2016
Pulmonary Disease, Chronic Obstructive	Phase 3	IL	Meridian Bioscience Israel Ltd.	30 Sep 2010
Hepatitis B, Chronic	Phase 3	IL	Hadassah University Hospital	17 Sep 2010
liver function failure	Phase 3	US	Meridian Bioscience Israel Ltd.	31 Mar 2010
liver function failure	Phase 3	IL	Meridian Bioscience Israel Ltd.	31 Mar 2010
Fibrosis	Phase 3	US	Meridian Bioscience Israel Ltd.	31 Aug 2008
Fibrosis	Phase 3	IL	Meridian Bioscience Israel Ltd.	31 Aug 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03611101 (CTgov)	Not Applicable	Nonalcoholic Steatohepatitis	124	BreathID MCS device+BMS-986036+¹³C-Methacetin Breath Test	yzpaqunchm(lxobatomsq) = omlmodjkzq rraqyzxoja (aptvzarjis, qxopqigdmp - ljmcanokpo) View more	-	09 Aug 2022
NCT02786836 (ALFSG-MBT, CTgov)	Phase 2/3	Chemical and Drug Induced Liver Injury \| Liver Failure, Acute	76	13C-Methacetin	zryayrjdju(uqzozxjtuk) = kvsabaqzwv nouhbcorqp (pdbdazybmt, nqeejqzsrw - dsucsiffrr) View more	-	22 Dec 2020
EASL2020	Not Applicable	liver function failure	15	13C-methacetin	ptpvxlknxv(canazeyrzr) = uyivrtuoxy avfcqlnasx (opfwqjwlvi, 753 - 61)	-	27 Aug 2020

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