NCT02098785: NOCTUA

Phase I Clinical Trial Investigating the Effects of Caffeine Citrate on Serum Vascular Adhesion Protein -1 (VAP-1) Levels in Healthy Volunteers.

Withdrawn Phase 1 Last updated 17 April 2018

What this trial tests

Phase 1 trial testing Caffeine citrate in Liver Disease. Withdrawn.

Timeline

1 March 2018

Primary endpoint
1 September 2018

1 September 2018

Quick facts

Lead sponsor	University of Birmingham
Phase	Phase 1
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Start date	1 March 2018
Primary completion	1 September 2018
Estimated completion	1 September 2018
Sites	1 location across United Kingdom

Drugs / interventions tested

• Caffeine citrate — full drug profile →

Conditions studied

• Liver Disease — all drugs for Liver Disease →

Sponsor

University of Birmingham

Who can join

Adults 18 to 70, any sex, with Liver Disease. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• VAP-1 serum levels
  Time frame: VAP-1 serum levels at 60, 90 and 120 minutes post administration of caffeine citrate (Peyona)
  The aim of the trial is to examine whether caffeine blocks vascular adhesion protein-1 (VAP-1) activity in the blood of healthy human volunteers and thus prove to be of medicinal value in liver disease.

Sponsor's own description

Worldwide, liver related morbidity and mortality continue to rise. It is the 5th commonest cause of death in the UK. Liver damage consists of two main components - a) damage to the cells of the liver, called hepatocytes, meaning the liver cannot function properly leading to jaundice (yellow appearance of the skin and/or eyes) and liver failure and b) scarring of the liver, called Cirrhosis, leading to impaired function and inadequate blood flow through the liver with potential to develop into cancer. Manifestations of this state include ascites (fluid in the tummy) and varices (swollen blood vessels in the food pipe). Liver transplant is currently the only curative treatment for end stage chronic liver disease. Unfortunately its high demand has not been matched by an equivalent rise in liver donations and even when a transplant has occurred there are numerous lifestyle effects such as immunosuppression and kidney impairment thus outcome remains poor for many patients. Coffee has been shown to have mortality benefit in humans and drinking two to three cups a day was associated with a 40% reduced risk of developing cirrhosis, particularly alcohol related; and higher the more cups consumed. Previous work has demonstrated coffee reduces the level of fibrosis in the liver by interrupting signalling pathways, blocking the effects of special products, called cytokines, and reducing accumulation of iron. The investigators' hypothesis is that given the potential for caffeine to be used as a treatment in SSAO activity associated diseases it is important to see if the activity of SSAO can be blocked in healthy humans too. The Investigators' aim to examine the effect of caffeine on circulating VAP-1 levels in large numbers of healthy volunteers to assess its potential as an attractive therapeutic target in view of its low toxicity and widespread availability.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Risk factors and prevention of hepatocellular carcinoma in the era of precision medicine.
   Fujiwara N, Friedman SL, Goossens N, Hoshida Y. · · 2018 · cited 519× · PMID 28989095 · DOI 10.1016/j.jhep.2017.09.016
2. Generic chemoprevention of hepatocellular carcinoma.
   Athuluri-Divakar SK, Hoshida Y. · · 2019 · cited 18× · PMID 30221358 · DOI 10.1111/nyas.13971