ICP Care is very involved in advocacy and education regarding Intrahepatic Cholestasis of Pregnancy. We are in contact with some of the lead researchers in the field to stay up to date on the latest evidence based guidance and studies.
One of the ways ICP Care identified is to help guide research in the future through our shared experience as patients and vast knowledge of the disease. In the future, there may be opportunities to participate in research projects through our community. Given the rare nature of Intrahepatic Cholestasis of Pregnancy, recruitment of patients for studies can often be cumbersome. There may be opportunities in the near future for the ICP Care community to participate in research in the form of surveys or studies. One of the avenues that has not been much explored in ICP is the patient experience including the emotional aspects of this disease. Stay tuned for where we head in this exciting direction!
Research Projects Currently Enrolling Participants
OHANA Study: A new drug treatment possibility for ICP!
Mirum Pharmaceuticals is enrolling participants who are currently pregnant (between 20-34 weeks) and diagnosed with Intrahepatic Cholestasis of Pregnancy. They are performing a drug trial of their drug, volixibat. This drug has been shown to reduce bile acid levels in the bloodstream by binding to bile acids in the intestines and eliminating them. Because this drug remains in the intestines and is not highly absorbed, it has been shown to be safe in pregnancy.
Safety is a top priority of this study and bile acids will be followed weekly throughout the study. There are options to opt out of the study at any point if safety becomes a concern. While ICP Care is not running this study, we have had several conversations with the team at Mirum Pharmaceuticals to discuss what would be important to patients with Intrahepatic Cholestasis of Pregnancy. As we all have a personal connection to ICP, we have given them guidance that safety and close monitoring of bile acids would be very important to patients with cholestasis and this is a main concern of theirs as well.
There are several US sites that are enrolling for this trial including Yale, Galveston, San Antonio, Houston, Miami, and Birmingham. Because in person visits will be required, you should live near one of these sites. More sites are being added monthly though and if you are interested you can check the website for the trial to see if there is a site near you. Please be sure to advise them you read the information about the OHANA trial on the ICP Care website. This will help the OHANA team to monitor the recruitment location from the only United States ICP Care 501c3 non profit charity.
You can find out more information at https://ohanaicpstudy.com/#aboutohana
Or you may contact the research team directly at firstname.lastname@example.org
Thank you for your consideration in helping future patients with Intrahepatic Cholestasis of Pregnancy!
Survey Project looking at current treatment guidelines for ICP as well as emotional aspects of the disorder
If you have had ICP in a current or past pregnancy, please consider filling out this short survey which should take 10-15 minutes to complete.
This survey will help gauge what type of care patients with Intrahepatic Cholestasis of Pregnancy (ICP) are currently receiving. It also aims to help bring light to some of the emotional aspects of the disorder. Hopefully the responses from this survey will help to improve care in the future for patients with ICP!
Please only take this survey once. This survey was previously posted on ICP Care’s social media pages.
Survey link: https://www.surveymonkey.com/r/TP3TTC5
Research Opportunity looking at the interactions between Covid-19 and ICP
Research project enrolling participants who had both Covid-19 and Intrahepatic Cholestasis of Pregnancy in a recent pregnancy. Coming in January 2022! Check back on this page for updates.
United States of America
Dr. Richard H. Lee is a board-certified maternal-fetal medicine specialist at the Keck School of Medicine of the University of Southern California. His research interests include medical diseases in pregnancy and obstetrical complications. He has several research publications on intrahepatic cholestasis of pregnancy.
Dr. Lee is particularly interested in the clinical outcomes and approaches towards lowering perinatal morbidity and mortality in pregnancies affected by Intrahepatic Cholestasis of Pregnancy. He has studied the outcomes of pregnancies with the active management of ICP, the effect of bile acid concentrations on perinatal outcome in Intrahepatic Cholestasis of Pregnancy, the effect of bile acids on the human fetal heart during pregnancy, and the normal bile acid range in pregnancy. He has co-authored several reviews on Intrahepatic Cholestasis of Pregnancy. He is currently collaborating with Dr. Laura Bull (UCSF), investigating the ethnic and genetic factors contributing to the risk of developing ICP.
Dr. Jonathan K Mays is Director of Maternal Fetal Medicine at Metropolitan Hospital Center/New York Medical College, New York, NY. His Six-Year Cohort study is the largest prospective study regarding Intrahepatic Cholestasis of Pregnancy in the United States to date. He has published several papers in the area of maternal-fetal medicine, with specific emphasis on ICP. Dr. Mays has studied approaches to active management of the condition and the ideal time to intervene with induction of labor. He is currently working on a research project to investigate the genetics of Intrahepatic Cholestasis of Pregnancy.
Perinatal Research Group, Dr. Cecilia Estiu in Argentina from Hospital Ramon Sarda published a Clinical Practice Guideline designed for diagnosis, monitoring and treatment for ICP. Its purpose is to recommend best practices to date based on the best available evidence for a significant number of clinical situations which occur with high frequency.
The Department of Medicine, University of Chile School of Medicine, Santiago, Chile, Dr. Humberto Reyes: Their work has included ICP in twin pregnancies, estrogen’s role in ICP, bile acids and progesterone metabolites in ICP, and a retrospective analysis of their 12-year experience treating ICP patients with UDCA. At 3 months, all infants developed normally. The drug was well tolerated and no adverse effects were detected in their infants. Twenty-six children whose mothers received UDCA were re-examined after 1-12 years and they and their mothers were healthy.
Professor Bill Hague, of the University of Adelaide’s Robinson Research Institute will lead an international, multi-centre project to help find the best treatment for a rare pregnancy complication that can cause increased risk of preterm and still birth, and considerable distress.
The multi-centre study will compare the clinical outcomes of two drugs – ursodeoxycholic acid (UDCA), which can help reduce the itching in pregnancy, as well as improve abnormal liver function, and rifampicin, which has been used for similar itching outside of pregnancy, but which, to date, has not formally been tested in ICP.
Dr. José Juan García Marín is Professor at La Universidad de Salamanca, Spain. For the last 15 years the Group of Research on Experimental Hepatology and Drug Targeting (HEVEFARM) at the University of Salamanca, Spain, has been interested in the study of the causes and disease progression of intrahepatic cholestasis of pregnancy (ICP). Particular attention has been devoted to the investigation of the consequences of bile acid accumulation in the mother on the development of fetal liver structure and function, as well as on the role of the placenta as protecting barrier, but also as organ affected by maternal hypercholanaemia. The group is also interested in evaluating the effect of drugs, such as ursodeoxycholic acid, and food components, such as vitamin C, on the protection against oxidative stress induced by the accumulation of biliary compounds in maternal blood. Recently, important advances have been achieved regarding the role of sulfated progesterone metabolites in the etiology of ICP. The relationship of the impairment in maternal liver and placenta function with abnormally increased levels of these compounds in patients with ICP is one of the subjects currently investigated by the HEVEFARM. In order to better advance in the understanding of ICP and contribute to the development of new treatments for women suffering from this disease, the HEVEFARM actively participates in several collaborative research studies with prestigious scientists, also interested in this health problem, in Europe, such as Dr. Catherine Williamson and Dr. Peter Dixon in U.K. from Imperial College, London, and Dr. Dieter Häussinger, Dr. Ralph Kubitz and Dr. Verena Keitel in Germany (Heinrich Heine University, Düsseldorf), and in America, such as Dr. Marco Arrese in Chile (Department of Gastroenterology, Pontificia Universidad Católica de Chile, Santiago) and Dr. Cecilia Estiu (Hospital Materno Infantil Ramón Sardá, Buenos Aires) and Dr. Aldo Mottino and Dr. Carolina Gahem (Instituto de Investigaciones Farmacológicas, Facultad de Farmacia y Bioquímica, CONICET-Universidad de Buenos Aires, Buenos Aires) in Argentina.
More information on the research group, staff, activities, and a complete list of publications can be found at the HEVEFARM Web site: http://www.usal.es/webusal/en/node/342
The Maternal and Fetal Disease Research group in London.
Professor Catherine Williamson is Professor of Women’s Health at King’s College London and is head of a research group who for the past twenty years have been researching the role of genetics and hormones in ICP. Their work also includes a focus on the placenta, the fetal heart and the longer term impact of ICP on women and their children.