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OHANA 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.

OHANA logo

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?).

We’ve only given you a very basic overview of the study, so please do have a look at it in more detail on the OHANA site as well as here at clinicaltrials.gov.

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.

United Kingdom

Medway NHS Foundation Trust
Gillingham, Kent, United Kingdom, ME7 5NY

University Hospital of Wales
Cardiff, United Kingdom, CF14 4XW

St Richards Hospital
Chichester, United Kingdom, PO19 6SE
Contact: Marian Flynn-Batham marian.flynn-batham@nhs.net

St Thomas’ Hospital
London, United Kingdom, SE1 7EH

Sunderland Royal Hospital, South Tyneside Sunderland NHS Trust
Sunderland, United Kingdom, SR4 7TP
Contact: Judith Ormonde 07903 971148 judith.ormonde@nhs.net

United States, Alabama

University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Contact: Stacy Harris 205-996-6262 stacylharris@uabmc.edu

United States, Connecticut

Yale School of Medicine
New Haven, Connecticut, United States, 06511
Contact: Lauren Parley 203-500-3995 lauren.perley@yale.edu

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 assalaza@utmb.edu

University of Texas Health Science Center
Houston, Texas, United States, 77030
Contact: Sunbola Ashimi 713-500-6410 sunbola.s.ashimi@uth.tmc.edu

New Zealand

Capital & Coast District Health Board
Newtown, Wellington, New Zealand, 6021

Christchurch Women’s Hospital
Christchurch, New Zealand, 8011