OHANA medication trial
The OHANA (which means family) trial started in January 2021. The trial introduces a new medication to treat intrahepatic cholestasis of pregnancy (ICP), called volixibat.
What is volixibat?
Volixibat is an ileal bile acid transport (IBAT) inhibitor, meaning that it prevents uptake of bile acids from the gut. iBAT inhibitors are also called apical sodium-dependent bile acid transporter (ASBT) inhibitors.
The role of a bile acid transporter is to help the gut reabsorb bile acids from the intestine to help them return to the liver – it’s all part of a very efficient recycling process that happens with bile acids called the enterohepatic circulation. This process ensures that the bile acids do the work they need to do (helping us to digest our food and absorb fat-soluble vitamins for example), while meaning that the liver does not have to continually make new bile acids. Careful control processes keep the concentrations of bile acids in the body at a level that doesn’t cause any harm to the liver or bile ducts (because bile acids are quite toxic at high concentrations). A bile acid transporter inhibitor can reduce the concentrations of bile acids being re-absorbed.
Why would I want to take an ileal bile acid transporter inhibitor if I have ICP?
In ICP the flow of bile acids from the liver to the gut becomes sluggish (cholestasis) thought to be caused by a combination of pregnancy hormones, the environment and genetics and meaning that bile acid concentrations rise in the blood. Although these higher concentrations aren’t life-threatening for the pregnant woman, they may be for the baby, and once over 100 µmol/L they increase the risk of stillbirth to 3.44%. This means that some way needs to be found to reduce these increased concentrations, which usually involves prescribing medication.
The current choice of medication to treat ICP is ursodeoxycholic acid, but this hasn’t been as effective as doctors as hoped it would be in reducing itch or bile acids (but it can still reduce the risk of spontaneous premature birth), so a new medication is needed, and that’s where volixibat comes in. Mirum Pharmaceuticals believe that volixibat can help women who have ICP by inhibiting the reabsorption of bile acids and reducing any high concentrations, meaning that the risk of stillbirth is also reduced. They also hope that it will help to improve itch as well. Volixibat has been used safely in other liver conditions and the ‘plus’ of it is that it does not enter the maternal blood stream but goes straight to the gut – in essence, women taking this medication should poo out excess bile acids!
What will this trial do?
OHANA is what is called a Phase 2a/2b trial, meaning that the medication has already been tested for safety but may still have some side effects that haven’t been identified. These trials are usually smaller than the next stage (Phase 3 trials) and will typically involve just a few hundred people. This link can tell you a little more about the different phases of trials that there are.
In OHANA women will be randomised to take either volixibat or a placebo (a tablet that will look just like the volixibat tablet but which won’t contain the active ingredient of the medication) and no one will know who is taking what until the trial is complete (called a double-blind trial).
Overall, the trial will look at how bile acid concentrations respond to volixibat, what impact it has on itch, and what impact it has on baby outcomes (for example, will it reduce the incidence of meconium staining which is associated with ICP?).
Hospitals recruiting to OHANA
We’ve listed the sites currently recruiting and if you live in one of these areas and you are interested in knowing more, perhaps with a view to taking part, you can contact the person listed – this does NOT commit you to anything – you will simply be expressing an interest in learning more. If you do contact someone, please tell them that you saw information about the trial on this website, as it helps the study team to monitor where recruitment is coming from.
Medway NHS Foundation Trust
Gillingham, Kent, United Kingdom, ME7 5NY
Contact Emma Sackett 01634 830000 ext.3532 Emma.firstname.lastname@example.org
Birmingham Women’s and Children’s NHS Foundation Trust
Birmingham, United Kingdom, B15 2TG
Contact: Chloe O’Hara 0121 472 1377 ext 5779 email@example.com
University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW
Maryanne Bray Maryanne.firstname.lastname@example.org 02921 841615
St Richards Hospital
Chichester, United Kingdom, PO19 6SE
Contacts: Marian Flynn-Batham 01243 788122 ext 32047 email@example.com
Emma Meadows 01243 788122 ext 32768 firstname.lastname@example.org
Royal Free NHS FT
London, United Kingdom, NW3 2QG
Contact: Michelle Anderson 020 7794 0500 ext 31237 email@example.com
St Thomas’ Hospital
London, United Kingdom, SE1 7EH
Julie Wade 0207 1883570 Julie.firstname.lastname@example.org
West Middlesex University Hospital
Middlesex, United Kingdom, TW7 6AF
Contact: Amy Barker 020 8321 5427 email@example.com
Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle Upon Tyne, United Kingdom
Contact: Victoria Murtha 01912 448824 firstname.lastname@example.org
Sunderland Royal Hospital, South Tyneside Sunderland NHS Trust
Sunderland, United Kingdom, SR4 7TP
Contact: Judith Ormonde 07903 971148 email@example.com
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Contact: Stacy Harris 205-996-6262 firstname.lastname@example.org
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06511
Contact: Lauren Parley 203-500-3995 email@example.com
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Contact: Rohit Singh 305-243-9214 firstname.lastname@example.org
United States, Texas
The University of Texas Medical Branch – Galveston
Galveston, Texas, United States, 77555
Contact: Liz Welch 409-747-6622 elwelch@UTMB.EDU
Contact: Ashley Salazar 409-772-0312 email@example.com
University of Texas Health Science Center
Houston, Texas, United States, 77030
Contact: Sunbola Ashimi 713-500-6410 firstname.lastname@example.org
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Contact: Marisa Fernandez 210-450-8016 email@example.com
Capital & Coast District Health Board
Newtown, Wellington, New Zealand, 6021
Christchurch Women’s Hospital
Christchurch, New Zealand, 8011