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.

开始日期2018-05-04

申办/合作机构

Meridian Bioscience, Inc.

[+1]

NCT02786836

/ Completed临床2/3期IIT

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.

开始日期2016-06-10

申办/合作机构

The University of Texas Southwestern Medical Center

[+4]

NCT02084160

/ CompletedN/A

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.

开始日期2014-03-01

申办/合作机构

Meridian Bioscience, Inc.

100 项与 13C-Methacetin(University of Texas Southwestern Medical Center) 相关的临床结果

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100 项与 13C-Methacetin(University of Texas Southwestern Medical Center) 相关的转化医学

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100 项与 13C-Methacetin(University of Texas Southwestern Medical Center) 相关的专利（医药）

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项与 13C-Methacetin(University of Texas Southwestern Medical Center) 相关的文献（医药）

2024-10-01·Biodegradation

Delineating acetaminophen biodegradation kinetics and metabolomics using bacterial community

Article

作者: 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.

2018-09-01·European radiology2区 · 医学

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

2区 · 医学

Article

作者: Poelsterl, Stefanie ; Fuhrmann, Irene ; Stroszczynski, Christian ; Nickel, Marcel D ; Verloh, Niklas ; Wiggermann, Philipp ; Fellner, Claudia ; Dahlke, Marc H ; 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.

2015-01-01·The Journal of surgical research4区 · 医学

Reliable assessment of liver function using LiMAx

4区 · 医学

Article

作者: Jara, Maximilian ; Malinowski, Maciej ; Valle, Erika ; Schulz, Antje ; Lock, Johan Friso ; Stockmann, Martin ; Jung, Tobias ; Seehofer, Daniel ; Bednarsch, Jan

BACKGROUND:

(13)C-liver function breath tests can facilitate the assessment of hepatic function in-vivo and may help surgeons to identify candidates for safe liver surgery. However, their acceptance into clinical practice is dependent on evaluation of technical efficacy and repeatability. The aims of this study were to evaluate the within-subject repeatability of the LiMAx (maximum liver function capacity) test in healthy individuals and in surgical patients to determine liver function in the perioperative workup.

MATERIAL AND METHODS:

The LiMAx test, which is based on intravenous injection of (13)C-methacetin at a dosage of 2 mg/kg body weight was performed in eighty-six healthy subjects to determine a reference range. Twenty-four subjects underwent repeat LiMAx testing the following day to assess within-subject repeatability. Twenty-one patients undergoing elective extra-abdominal surgery under general anesthesia (GA group) received pre- and post-operative examinations.

RESULTS:

The normal range of LiMAx was found to be 430 ± 86 μg/kg/h and revealed a one-sided cut-off value of 315 μg/kg/h. The intraclass correlation coefficient of the repeat LiMAx tests was 0.85 (95% confidence interval 0.69-0.93) in the control group and 0.81 (95% confidence interval 0.60-0.92) in the group of patients with GA.

CONCLUSIONS:

The LiMAx test shows excellent reproducibility in subjects with normal liver function. GA has no effect on test results.

项与 13C-Methacetin(University of Texas Southwestern Medical Center) 相关的新闻（医药）

2018-11-05

·GlobeNewswire

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

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100 项与 13C-Methacetin(University of Texas Southwestern Medical Center) 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
药物性肝损伤	临床3期	美国	The University of Texas Southwestern Medical Center	2016-06-10
药物性肝损伤	临床3期	美国	Meridian Bioscience, Inc.	2016-06-10
急性肝功能衰竭	临床3期	美国	The University of Texas Southwestern Medical Center	2016-06-10
急性肝功能衰竭	临床3期	美国	Meridian Bioscience, Inc.	2016-06-10
慢性阻塞性肺疾病	临床3期	以色列	Meridian Bioscience Israel Ltd.	2010-09-30
慢性乙型肝炎	临床3期	以色列	Hadassah University Hospital	2010-09-17
肝功能衰竭	临床3期	美国	Meridian Bioscience Israel Ltd.	2010-03-31
肝功能衰竭	临床3期	以色列	Meridian Bioscience Israel Ltd.	2010-03-31
纤维化	临床3期	美国	Meridian Bioscience Israel Ltd.	2008-08-31
纤维化	临床3期	以色列	Meridian Bioscience Israel Ltd.	2008-08-31

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


SNMMI2023	N/A	-	-	13C-Methacetin Breath Tyttrium-90 (Radioembolization with yttrium-90-loaded resin microspheres)	鹹鏇製艱憲壓襯構願襯(廠憲糧衊艱襯積窪糧窪) = significant increase after 7 days 簾齋廠構衊廠艱醖築鑰 (糧壓餘衊積選壓醖積選 ) 更多	-	2023-08-28
NCT03611101 (CTgov)	N/A	非酒精性脂肪性肝炎	124	BreathID MCS device+BMS-986036+¹³C-Methacetin Breath Test	鏇衊窪鑰醖壓製獵艱遞(鏇鏇壓蓋膚衊選繭網襯) = 築醖構艱鬱積選獵遞鑰範製鬱壓夢鏇鹹衊壓範 (襯鬱蓋餘觸鬱構糧鏇簾, 築築觸顧網鑰鹹選顧簾 ~ 齋蓋構壓憲齋鏇鑰衊衊) 更多	-	2022-08-09
NCT02786836 (ALFSG-MBT, CTgov)	临床2/3期	药物性肝损伤 \| 急性肝功能衰竭	76	13C-Methacetin	顧蓋築獵鏇鹽鹽簾襯鏇(鑰網廠網廠鹹醖築窪繭) = 艱積積構獵壓衊選遞醖醖壓鏇築憲醖衊壓夢艱 (獵繭鹹範願鏇蓋艱鏇願, 願糧膚選衊襯襯蓋艱簾 ~ 膚遞選觸構簾衊繭艱簾) 更多	-	2020-12-22
EASL2020	N/A	肝功能衰竭	15	13C-methacetin (TIPS placement)	簾夢憲範鏇醖選繭艱築(衊繭繭廠衊餘醖衊繭構) = 齋顧衊憲範鬱壓顧網願膚膚構餘選廠蓋願選獵 (製糧夢製蓋選鏇顧廠網, 753 ~ 61)	-	2020-08-27