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Liver Disease

OACS-1 - Recruiting

OCALIVA for the Amelioration of Cognitive Symptoms trial – 1

  • Study stage: Recruiting
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: IIT, Intercept Pharmaceuticals
  • Therapeutic area: Liver Disease
  • Type of study: CTIMP (Rare Disease)

Aim: To assess the impact of OCA therapy at standard clinical doses on improvement in cognitive function in patients with PBC who are non-cirrhotic but experience significant cognitive symptoms, irrespective of whether they are UDCA responders or non-responders.

Primary Outcome:

The primary outcome is a composite score from the CANTAB cognitive testing platform. This score is derived from using individual scores from four core tests that have been identified and validated in the underpinning studies as being abnormal in PBC patients with significant cognitive symptoms.

 The core tests are:

    • One Touch Stockings of Cambridge (OTS)
    • Paired Associates Learning (PAL)
    • Rapid Visual Information Processing (RVP)
    • Spatial Working Memory (SWM)
  • Population: Adults
  • Phase: IIb
  • Design: RCT
  • Setting: Secondary care
  • Planned Sample Size: 40

OACS-2 - Recruiting

Obeticholic Acid for the Amelioration of Cognitive Symptoms trial - 2

  • Study stage: Recruiting
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: IIT, Intercept Pharmaceuticals
  • Therapeutic area: Liver Disease
  • Type of study: CTIMP (Rare Disease)

Aim: To assess the impact of OCA therapy at standard clinical doses on improvement in cognitive function in patients with recent onset PBC who are non-cirrhotic but experience significant cognitive symptoms, irrespective of whether they are UDCA responders or non-responders.

Primary Outcome:

The primary outcome is a composite score from the CANTAB cognitive testing platform.  This score is derived from using individual scores from four core tests that have been identified and validated in the underpinning studies as being abnormal in PBC patients with significant cognitive symptoms.

 The core tests are:

 One Touch Stockings of Cambridge (OTS)

    • Paired Associates Learning (PAL)
    • Rapid Visual Information Processing (RVP)
    • Spatial Working Memory (SWM)
  • Population: Adults
  • Phase: IIb
  • Design: RCT
  • Setting: Secondary care
  • Planned Sample Size: 25

OPERA - Recruiting

Optimising Primary Therapy in Primary Biliary Cholangitis 

  • Study stage: Recruiting
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: NIHR-EME Programme/Intercept Pharmaceuticals
  • Therapeutic area: Liver Disease
  • Type of study: CTIMP

Aim:  The aim of the OPERA trial is to see if people who are newly/recently diagnosed with PBC have a better outcome if they receive two medicines from the start rather than one.

Primary Outcome:  To assess the impact of first line obeticholic acid therapy combined with UDCA standard of care therapy compared to placebo in achieving biochemical remission of disease in new onset PBC patients with an enhanced disease risk.

  • Population: Adults
  • Phase: IIb
  • Design: RCT (double blind)
  • Setting: Secondary care
  • Planned Sample Size: 106

Website:  https://research.ncl.ac.uk/opera/

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