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1. Emricasan to prevent new decompensation in patients with NASH-related decompensated cirrhosis

Author

Corey, Kathleen, Bernstein, David, Noureddin, Mazen, Kemmer, Nyingi, DeLemos, Andrew, Pyrsopoulos, Nikolaos, Lee, William, Ghabril, Marwan, Scanga, Andrew, McKenzie, Mark, Lawitz, Eric, Figueroa-Diaz, Viviana, Simonetto, Douglas, Frederick, Richard, Brown, Kimberly, Therapondos, George, Sheikh, Aasim, Brandman, Danielle, Stein, Lance, Ankoma-Sey, Victor, Bhamidimarri, Kalyan, Landis, Charles, Fortune, Brett, Vargas, Hugo, Abdelmalek, Manal, Freilich, Bradley, Rockey, Don, Vierling, John, Tatum, Harvey, Curry, Michael, Shiffman, Mitchell, Bambha, Kiran, Ghalib, Reem, Stratton, Amy, Anwar, Nadeem, Caldwell, Stephen, Koteish, Ayman, Siddiqui, Mohammad, Saab, Sammy, Shah, Nikunj, Kohli, Anita, Rinella, Mary, Sarkar, Souvik, Torres, Dawn, Verna, Elizabeth, Ravendhran, Ravi, Reynolds, Justin, Thomason, Ray, Kim, Ray, Membreno, Fernando, Jakab, Sofia, Gonzalez, Stevan, Keaveny, Andrew, Pan, Jen-Jung, Gill, Satinder, Huang, Jonathan, Strobel, James, Wieland, Amanda, Morelli, Giuseppe, Amankonah, Thomas, Roytman, Marina, Schmidt, Warren, Abrams, Gary, Patel, Bhaktasharan, Frenette, Catherine, Kayali, Zeid, Mena, Edward, Mantry, Parvez S., Lucas, Kathryn J., Neff, Guy, Rodriguez, Miguel, Thuluvath, Paul J., Weinberg, Ethan, Bhandari, Bal R., Robinson, James, Wedick, Nicole, Chan, Jean L., Hagerty, David T., and Kowdley, Kris V.

Published
2021
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2. Randomized placebo-controlled trial of emricasan for non-alcoholic steatohepatitis-related cirrhosis with severe portal hypertension

Author

Abdelmalek, M., Bhamidimarri, K., Borg, B., Caldwell, S., Fenkel, J., Freilich, B., Fuchs, M., Ghabril, M., Ghalib, R., Gonzalez, S., Gordon, S., Hameed, B., Harrison, S., Kayali, Z., Kemmer, N., Korenblat, K., Lai, M., Landis, C., Lawitz, E., Lee, W., Lidofsky, S., Mena, E., Noureddin, M., Paredes, A., Pyrsopoulos, N., Reddy, R., Rinella, M., Rockey, D., Rodriguez, M., Ryan, M., Sarkar, S., Satapathy, S., Scanga, A., Shiffman, M., Siddiqui, M., Simonetto, D., Syn, W., Thuluvath, P., Vemulapalli, R., Vierling, J., Younes, Z., Albillos, A., Ruiz-Tapiador, J. Arenas, Augustin, S., Calleja, J., Garcia, J. Crespo, Buey, L. Garcia, Garcia-Pagan, J.C., Villanueva, C., Bureau, C., Carbonell, N., Leroy, V., Rautou, P.-E., Heinzow, H., Schiefke, I., Zipprich, A., Berzigotti, A., Muellhaupt, B., Garcia-Tsao, Guadalupe, Bosch, Jaime, Kayali, Zeid, Harrison, Stephen A., Abdelmalek, Manal F., Lawitz, Eric, Satapathy, Sanjaya K., Ghabril, Marwan, Shiffman, Mitchell L., Younes, Ziad H., Thuluvath, Paul J., Berzigotti, Annalisa, Albillos, Agustin, Robinson, James M., Hagerty, David T., Chan, Jean L., and Sanyal, Arun J.

Published
2020
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3. A randomized, placebo-controlled trial of emricasan in patients with NASH and F1-F3 fibrosis

Author

Harrison, Stephen A., Goodman, Zachary, Jabbar, Abdul, Vemulapalli, Ravi, Younes, Ziad H., Freilich, Bradley, Sheikh, Muhammad Y., Schattenberg, Jörn M., Kayali, Zeid, Zivony, Adam, Sheikh, Aasim, Garcia-Samaniego, Javier, Satapathy, Sanjaya K., Therapondos, George, Mena, Edward, Schuppan, Detlef, Robinson, James, Chan, Jean L., Hagerty, David T., and Sanyal, Arun J.

Published
2020
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4. Baseline characteristics of adults with classic congenital adrenal hyperplasia enrolled in CAHtalyst, a phase 3 study of Crinecerfont, a corticotropin-releasing factor type 1 receptor antagonist

Author

Auchus, Richard, primary, Hamidi, Oksana, additional, Pivonello, Rosario, additional, Bancos, Irina, additional, Witchel, Selma, additional, Isidori, Andrea, additional, Rodien, Patrice, additional, Srirangalingam, Umasuthan, additional, Kiefer, Florian, additional, Falhammar, Henrik, additional, Merke, Deborah, additional, Reisch, Nicole, additional, Sturgeon, Julia, additional, Roberts, Eiry, additional, Lin, Vivian, additional, Chan, Jean L, additional, and Farber, Robert, additional

Published
2024
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5. Emricasan Improves Liver Function in Patients With Cirrhosis and High Model for End-Stage Liver Disease Scores Compared With Placebo

Author

Frenette, Catherine T., Morelli, Giuseppe, Shiffman, Mitchell L., Frederick, R. Todd, Rubin, Raymond A., Fallon, Michael B., Cheng, Jason T., Cave, Matt, Khaderi, Saira A., Massoud, Omar, Pyrsopoulos, Nikolaos, Park, James S., Robinson, James M., Yamashita, Mason, Spada, Alfred P., Chan, Jean L., and Hagerty, David T.

Published
2019
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6. Crinecerfont, a CRF1 Receptor Antagonist, Lowers Adrenal Androgens in Adolescents With Congenital Adrenal Hyperplasia

Author

Newfield, Ron S, primary, Sarafoglou, Kyriakie, additional, Fechner, Patricia Y, additional, Nokoff, Natalie J, additional, Auchus, Richard J, additional, Vogiatzi, Maria G, additional, Jeha, George S, additional, Giri, Nagdeep, additional, Roberts, Eiry, additional, Sturgeon, Julia, additional, Chan, Jean L, additional, and Farber, Robert H, additional

Published
2023
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7. Crinecerfont (NBI-74788), a Novel CRF1 Receptor Antagonist, Lowers Adrenal Androgens and Precursors in Adolescents with Classic Congenital Adrenal Hyperplasia

Author

Newfield, Ron, primary, Sarafoglou, Kyriakie, additional, Fechner, Patricia Y., additional, Nokoff, Natalie J., additional, Auchus, Richard, additional, Vogiatzi, Maria, additional, Giri, Nagdeep, additional, Roberts, Eiry, additional, Sturgeon, Julia, additional, Chan, Jean L., additional, and Farber, Robert, additional

Published
2023
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10. Crinecerfont, a CRF1 Receptor Antagonist, Lowers Adrenal Androgens in Adolescents With Congenital Adrenal Hyperplasia.

Author

Newfield, Ron S., Sarafoglou, Kyriakie, Fechner, Patricia Y., Nokoff, Natalie J., Auchus, Richard J., Vogiatzi, Maria G., Jeha, George S., Giri, Nagdeep, Roberts, Eiry, Sturgeon, Julia, Chan, Jean L., and Farber, Robert H.

Subjects
ANDROGENS, ADRENOGENITAL syndrome
Abstract

Context: Crinecerfont, a corticotropin-releasing factor type 1 receptor antagonist, has been shown to reduce elevated adrenal androgens and precursors in adults with congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21OHD), a rare autosomal recessive disorder characterized by cortisol deficiency and androgen excess due to elevated adrenocorticotropin. Objective: To evaluate the safety, tolerability, and efficacy of crinecerfont in adolescents with 21OHD CAH. Methods: This was an open-label, phase 2 study (NCT04045145) at 4 centers in the United States. Participants were males and females, 14 to 17 years of age, with classic 21OHD CAH. Crinecerfont was administered orally (50 mg twice daily) for 14 consecutive days with morning and evening meals. The main outcomes were change from baseline to day 14 in circulating concentrations of ACTH, 17-hydroxyprogesterone (17OHP), androstenedione, and testosterone. Results: 8 participants (3 males, 5 females) were enrolled; median age was 15 years and 88% were Caucasian/White. After 14 days of crinecerfont, median percent reductions from baseline to day 14 were as follows: ACTH, -57%; 17OHP, -69%; and androstenedione, -58%. In female participants, 60% (3/5) had =50% reduction from baseline in testosterone. Conclusion: Adolescents with classic 21OHD CAH had substantial reductions in adrenal androgens and androgen precursors after 14 days of oral crinecerfont administration. These results are consistent with a study of crinecerfont in adults with classic 21OHD CAH. [ABSTRACT FROM AUTHOR]

Published
2023
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15. Noninvasive predictors of clinically significant portal hypertension in cirrhosis : Validation of models and development of a lab-based model

Author

Rabiee, Anahita, Deng, Yanhong, Ciarleglio, Maria, Chan, Jean L., Pons, Monica, Genescà Ferrer, Joan, Garcia-Tsao, Guadalupe, and Universitat Autònoma de Barcelona

Abstract

Altres ajuts: Yale Liver Center P30 DK34989 Clinically significant portal hypertension (CSPH), defined as hepatic venous pressure gradient (HVPG) ≥ 10 mm Hg, identifies patients with compensated cirrhosis at a high risk of decompensation. However, HVPG is an invasive and nuanced method. The ANTICIPATE models, which include liver stiffness measurements by transient elastography (TE) and platelet count ± body mass index, are robust noninvasive surrogates of CSPH but required external validation in patients with nonalcoholic steatohepatitis (NASH) cirrhosis. Additionally, TE is not widely available worldwide. The aims of the study were: (1) to externally validate the ANTICIPATE models using baseline data from patients with compensated NASH cirrhosis screened/enrolled in a multicenter international randomized controlled trial; and (2) to develop and externally validate a model using only laboratory values. Regarding aim 1, both ANTICIPATE models showed good calibration and discrimination (area under the curve [AUC] > 0.8) in our cohort (n = 222). Regarding aim 2, a new lab-based model using the Fibrosis-4 index (FIB-4 [age, aspartate aminotransferase, alanine aminotransferase, platelet count]) plus serum albumin was developed. The discrimination in the training cohort (n = 309) was good (AUC of 0.78 [95% confidence interval [CI]:0.72-0.83]). It was then externally validated in a separate cohort of 245 patients with compensated NASH cirrhosis (AUC of 0.8 [95% CI: 0.75-0.86]). Given the difference in the prevalence of CSPH between training (74%) and validation (39%) cohorts, the model required an update of the baseline risk to achieve a good calibration. The updated model was named FIB4+. In conclusion, both ANTICIPATE models performed well in predicting the presence of CSPH in NASH cirrhosis. A model using FIB-4 plus albumin (FIB4+) can be used to predict CSPH where TE is not available.

Published
2022

23. Recombinant human leptin in women with hypothalamic amenorrhea

Author

Welt, Corrine K., Chan, Jean L., Murphy, Robyn, and Smith, Patricia

Subjects
Menstruation disorders -- Risk factors, Menstruation disorders -- Care and treatment, Women -- Health aspects, Hypothalamic hormones -- Research
Abstract

In this prospective, interventional study of 8 women with hypothalamic amenorrhea, leptin administration led to normalization of levels of reproductive hormones, follicular development, and menstrual cyclicity. Leptin administration for the relative leptin deficiency in women with hypothalamic amenorrhea appears to improve reproductive, thyroid, and growth hormone axes and markers of bone formation.

Published
2004

27. Emricasan to prevent new decompensation in patients with NASH-related decompensated cirrhosis

Author

Frenette, Catherine, primary, Kayali, Zeid, additional, Mena, Edward, additional, Mantry, Parvez S., additional, Lucas, Kathryn J., additional, Neff, Guy, additional, Rodriguez, Miguel, additional, Thuluvath, Paul J., additional, Weinberg, Ethan, additional, Bhandari, Bal R., additional, Robinson, James, additional, Wedick, Nicole, additional, Chan, Jean L., additional, Hagerty, David T., additional, Kowdley, Kris V., additional, Corey, Kathleen, additional, Bernstein, David, additional, Noureddin, Mazen, additional, Kemmer, Nyingi, additional, DeLemos, Andrew, additional, Pyrsopoulos, Nikolaos, additional, Lee, William, additional, Ghabril, Marwan, additional, Scanga, Andrew, additional, McKenzie, Mark, additional, Lawitz, Eric, additional, Figueroa-Diaz, Viviana, additional, Simonetto, Douglas, additional, Frederick, Richard, additional, Brown, Kimberly, additional, Therapondos, George, additional, Sheikh, Aasim, additional, Brandman, Danielle, additional, Stein, Lance, additional, Ankoma-Sey, Victor, additional, Bhamidimarri, Kalyan, additional, Landis, Charles, additional, Fortune, Brett, additional, Vargas, Hugo, additional, Abdelmalek, Manal, additional, Freilich, Bradley, additional, Rockey, Don, additional, Vierling, John, additional, Tatum, Harvey, additional, Curry, Michael, additional, Shiffman, Mitchell, additional, Bambha, Kiran, additional, Ghalib, Reem, additional, Stratton, Amy, additional, Anwar, Nadeem, additional, Caldwell, Stephen, additional, Koteish, Ayman, additional, Siddiqui, Mohammad, additional, Saab, Sammy, additional, Shah, Nikunj, additional, Kohli, Anita, additional, Rinella, Mary, additional, Sarkar, Souvik, additional, Torres, Dawn, additional, Verna, Elizabeth, additional, Ravendhran, Ravi, additional, Reynolds, Justin, additional, Thomason, Ray, additional, Kim, Ray, additional, Membreno, Fernando, additional, Jakab, Sofia, additional, Gonzalez, Stevan, additional, Keaveny, Andrew, additional, Pan, Jen-Jung, additional, Gill, Satinder, additional, Huang, Jonathan, additional, Strobel, James, additional, Wieland, Amanda, additional, Morelli, Giuseppe, additional, Amankonah, Thomas, additional, Roytman, Marina, additional, Schmidt, Warren, additional, Abrams, Gary, additional, and Patel, Bhaktasharan, additional

Published
2021
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29. Multicenter, Double‐Blind, Randomized Trial of Emricasan in Hepatitis C–Treated Liver Transplant Recipients With Residual Fibrosis or Cirrhosis

Author

Weinberg, Ethan M., primary, Curry, Michael P., additional, Frenette, Catherine T., additional, Regenstein, Fredric G., additional, Schiff, Eugene R., additional, Goodman, Zachary D., additional, Robinson, James M., additional, Chan, Jean L., additional, Imperial, Joanne C., additional, and Reddy, K. Rajender, additional

Published
2020
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30. Attribution of Nonalcoholic Steatohepatitis as an Etiology of Cirrhosis for Clinical Trials Eligibility: Recommendations From the Multi-stakeholder Liver Forum

Author

Noureddin, Mazen, primary, Chan, Jean L., additional, Barradas, Katherine, additional, Dimick-Santos, Lara, additional, Schabel, Elmer, additional, Omokaro, Stephanie O., additional, Anania, Frank A., additional, Myers, Robert P., additional, Miller, Veronica, additional, Sanyal, Arun J., additional, Chalasani, Naga, additional, Bajaj, Jasmohan, additional, Berzigotti, Annalisa, additional, Birman, Pascal, additional, Bosch, Jaime, additional, Brower, Ashley, additional, Calboli, Dania, additional, Charlton, William, additional, Dickinson, Klara, additional, Filozof, Claudia, additional, Forsgren, Mikael F., additional, Fuchs, Michael, additional, Garcia-Tsao, Guadalupe, additional, Gonzalez-Abraldes, Juan, additional, Gruss, Hans-Juergen, additional, Hansen, Morten, additional, Hosman, Suneil, additional, Imperial, Joanne, additional, Jones, David, additional, Lalazar, Gadi, additional, Leinhard, Olof Dahlqvist, additional, Lyons, Erica, additional, McColgan, Brian, additional, Mehta, Ruby, additional, Mesenbrink, Peter, additional, Myers, Rob, additional, Noureddin, Mazen, additional, Pei, Veronica, additional, Ratziu, Vlad, additional, Regev, Arie, additional, Riccio, Robert, additional, Sanyal, Arun, additional, Seo, Suna, additional, Smith, Alastair, additional, Szitanyi, Peter, additional, and Traber, Peter, additional

Published
2020
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31. Randomized placebo-controlled trial of emricasan for non-alcoholic steatohepatitis-related cirrhosis with severe portal hypertension

Author

Garcia-Tsao, Guadalupe, primary, Bosch, Jaime, additional, Kayali, Zeid, additional, Harrison, Stephen A., additional, Abdelmalek, Manal F., additional, Lawitz, Eric, additional, Satapathy, Sanjaya K., additional, Ghabril, Marwan, additional, Shiffman, Mitchell L., additional, Younes, Ziad H., additional, Thuluvath, Paul J., additional, Berzigotti, Annalisa, additional, Albillos, Agustin, additional, Robinson, James M., additional, Hagerty, David T., additional, Chan, Jean L., additional, Sanyal, Arun J., additional, Abdelmalek, M., additional, Bhamidimarri, K., additional, Borg, B., additional, Caldwell, S., additional, Fenkel, J., additional, Freilich, B., additional, Fuchs, M., additional, Ghabril, M., additional, Ghalib, R., additional, Gonzalez, S., additional, Gordon, S., additional, Hameed, B., additional, Harrison, S., additional, Kayali, Z., additional, Kemmer, N., additional, Korenblat, K., additional, Lai, M., additional, Landis, C., additional, Lawitz, E., additional, Lee, W., additional, Lidofsky, S., additional, Mena, E., additional, Noureddin, M., additional, Paredes, A., additional, Pyrsopoulos, N., additional, Reddy, R., additional, Rinella, M., additional, Rockey, D., additional, Rodriguez, M., additional, Ryan, M., additional, Sarkar, S., additional, Satapathy, S., additional, Scanga, A., additional, Shiffman, M., additional, Siddiqui, M., additional, Simonetto, D., additional, Syn, W., additional, Thuluvath, P., additional, Vemulapalli, R., additional, Vierling, J., additional, Younes, Z., additional, Albillos, A., additional, Ruiz-Tapiador, J. Arenas, additional, Augustin, S., additional, Calleja, J., additional, Garcia, J. Crespo, additional, Buey, L. Garcia, additional, Garcia-Pagan, J.C., additional, Villanueva, C., additional, Bureau, C., additional, Carbonell, N., additional, Leroy, V., additional, Rautou, P.-E., additional, Heinzow, H., additional, Schiefke, I., additional, Zipprich, A., additional, Berzigotti, A., additional, and Muellhaupt, B., additional

Published
2020
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40. Attribution of Nonalcoholic Steatohepatitis as an Etiology of Cirrhosis for Clinical Trials Eligibility : Recommendations From the Multi-stakeholder Liver Forum.

Author

Noureddin, Mazen, Chan, Jean L., Barradas, Katherine, Dimick-Santos, Lara, Schabel, Elmer, Omokaro, Stephanie O., Anania, Frank A., Myers, Robert P., Miller, Veronica, Sanyal, Arun J., Chalasani, Naga, Noureddin, Mazen, Chan, Jean L., Barradas, Katherine, Dimick-Santos, Lara, Schabel, Elmer, Omokaro, Stephanie O., Anania, Frank A., Myers, Robert P., Miller, Veronica, Sanyal, Arun J., and Chalasani, Naga

Published
2020
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46. Crinecerfont Lowers Elevated Hormone Markers in Adults With 21-Hydroxylase Deficiency Congenital Adrenal Hyperplasia.

Author

Auchus, Richard J., Sarafoglou, Kyriakie, Fechner, Patricia Y., Vogiatzi, Maria G., Ime, Erik A., Davis, Shanlee M., Giri, Nagdeep, Sturgeon, Julia, Roberts, Eiry, Chan, Jean L., and Farber, Robert H.

Subjects
HYDROXYLASES, ADRENOGENITAL syndrome
Abstract

Context: Classic congenital adrenal hyperplasia due to 21-hydroxylase deficiency (21OHD) is characterized by impaired cortisol synthesis and excess androgen production. Corticotropin-releasing factor type 1 receptor (CRF1R) antagonism may decrease adrenal androgen production. Objective: This work aimed to evaluate the safety, tolerability, and efficacy of crinecerfont (NBI-74788), a selective CRF1R antagonist, in 21OHD. Methods: This open-label, phase 2 study, with sequential cohort design (NCT03525886), took place in 6 centers in the United States. Participants included men and women, aged 18 to 50 years, with 21OHD. Interventions included 4 crinecerfont regimens, each administered orally for 14 consecutive days: 50 or 100 mg once daily at bedtime (cohorts 1 and 2, respectively); 100 mg once daily in the evening (cohort 3); and 100 mg twice daily (cohort 4). Participants could enroll in more than 1 cohort. Main outcomes included changes from baseline to day 14 in adrenocorticotropin (ACTH), 17-hydroxyprogesterone (17OHP), androstenedione, and testosterone. Results: Eighteen participants (11 women, 7 men) were enrolled: cohort 1 (n = 8), cohort 2 (n = 7), cohort 3 (n = 8), cohort 4 (n = 8). Mean age was 31 years; 94% were White. Median percent reductions were more than 60% for ACTH (-66%), 17OHP (-64%), and androstenedione (-64%) with crinecerfont 100 mg twice a day. In female participants, 73% (8/11) had a 50% or greater reduction in testosterone levels; male participants had median 26% to 65% decreases in androstenedione/testosterone ratios. Conclusion: Crinecerfont treatment for 14 days lowered ACTH and afforded clinically meaningful reductions of elevated 17OHP, androstenedione, testosterone (women), or androstenedione/testosterone ratio (men) in adults with 21OHD. Longer-term studies are required to evaluate the effects of crinecerfont on clinical end points of disordered steroidogenesis and glucocorticoid exposure in patients with 21OHD. [ABSTRACT FROM AUTHOR]

Published
2022
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