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.

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项与 [13C]美沙西汀相关的文献（医药）

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 ; Nickel, Marcel D ; Verloh, Niklas ; 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.

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.

1999-12-01·Zeitschrift fur Gastroenterologie

13C-methacetin breath test: isotope-selective nondispersive infrared spectrometry in comparison to isotope ratio mass spectrometry in volunteers and patients with liver cirrhosis.

Article

作者: Boedeker, C ; Luypaerts, A ; Pfaffenbach, B ; Adamek, R J ; Geypens, B ; Goetze, O

The 13C-methacetin breath test (MBT) has been proposed for the noninvasive evaluation of the hepatic mixed function oxidase activity. Up to now, stable isotope analysis of carbon dioxide of the MBT has been carried out with isotope ratio mass spectrometry (IRMS). The aim of the present study was to test a recently developed isotope-selective nondispersive infrared spectrometer (NDIRS) in comparison to IRMS in healthy volunteers and patients with liver cirrhosis. Ten healthy volunteers (range 22 to 76 years) and ten patients with histologically proven liver cirrhosis (range 47 to 71 years; Child Pugh score A = 5, B = 3, C = 2) were studied. After an overnight fast each subject received 2 mg/kg BW of 13C-methacetin dissolved in 100 ml of tea. Breath samples were obtained before substrate administration and after 5, 10, 15, 20, 30, 40, 50, 60, 80, 100, 120, 150, 180 min. The 13C/12C-ratio was analyzed in each breath sample both by NDIRS (IRIS, Wagner Analysen Technik, Worpswede, Germany) and CF-IRMS (ABCA, Europa Scientific, Crewe, UK). Results were expressed as delta over baseline (DOB [/1000]) and as cumulative percentage doses of 13C recovered (cPDR [%]) at each time interval. Correlations between IRMS and NDIRS were tested by linear regression correlation. For measuring agreement an Altman-Bland-plot was performed. Applying correlation analysis a linear correlation was found (DOB: y = 1.068 +/- 0.0012.x + 2.088 +/- 0.2126, r = 0.98, p < 0.0001; cPDR: y = 1.148 +/- 0.0109.x + 0.569 +/- 0.172; r = 0.99, p < 0.0001). For DOB the mean difference (d) was 2.9/1000 and the standard deviation (SD) of the difference was 2.7/1000. The limits of agreement (d +/- SD) were -2.5/1000 and 8.3/1000. The comparison of DOB- and cPDR-values by NDIRS and IRMS shows a high linear correlation. However, the distance of the limits of agreement is wide. Consequently, the validity of the MBT could be influenced which could make MBT by NDIRS unprecise for exact evaluation of hepatocellular dysfunction. Further studies are necessary to determine sensitivity and specifity of the MBT with NDIRS in larger study populations.

项与 [13C]美沙西汀相关的新闻（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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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	Meridian Bioscience, Inc.	2016-06-10
药物性肝损伤	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	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
肝功能衰竭	临床3期	德国	Humedics GmbH	2013-01-31
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
慢性肝病	临床3期	美国	Oridion Breathid, Inc.	2005-09-01
纤维化	临床3期	美国	Oridion Breathid, Inc.	2005-09-01
非酒精性脂肪性肝炎	临床3期	美国	Oridion Breathid, Inc.	2005-09-01

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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)	繭醖願醖襯鬱窪選廠齋(積觸鏇鏇糧築齋獵窪範) = significant increase after 7 days 選選醖淵網網觸壓夢糧 (鹹醖鹹窪網襯醖製襯繭 ) 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	廠築襯鹽觸遞夢觸築觸(鏇範糧壓簾餘窪餘膚襯) = 鑰製製襯築顧顧艱顧築構築獵襯選願膚夢顧觸 (獵鬱範製積憲膚顧繭選, 31.58) 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	淵觸積顧觸鏇鏇憲積夢(衊簾醖醖選簾醖積鬱鏇) = 夢繭選選鬱膚選窪襯獵淵襯顧築襯遞膚顧簾醖 (壓簾膚鏇選淵夢顧簾衊, 7.8) 更多	-	2020-12-22
EASL2020	N/A	肝功能衰竭	15	13C-methacetin (TIPS placement)	願積艱夢憲選夢築艱觸(構廠餘繭鹹構積顧築醖) = 餘遞壓願糧願鏇淵鬱構衊範醖遞積夢鏇網範鹹 (壓憲鹹鑰窪齋遞鹹鏇獵, 753 ~ 61)	-	2020-08-27