Condition category
Digestive System
Date applied
27/10/2009
Date assigned
11/02/2010
Last edited
08/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Julia Wendon

ORCID ID

Contact details

King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT01435421

Protocol/serial number

ALF-BID-1108

Study information

Scientific title

Breath test for patients with acute liver disease for early detection of the need for transplant or recovery: a multicentre non-randomised study

Acronym

BTALD (Breath Test in Acute Liver Disease)

Study hypothesis

This study is designed to develop a model to predict deterioration of liver disease, which incorporates measurements from the 13C-Methacetin Breath Test (MBT) along with other potential variables. The data collected will be used to develop a prediction model using data-mining methodology (linear and non-linear regression models, binary trees, neural networks, etc.,). The predictive models may include measurements from the MBT and blood test results as single measurements or as a trend over time. The model that will be developed will attempt to predict the disease deterioration versus recovery accurately, at an earlier time point than the standard procedure. A threshold will then be determined based on adequate sensitivity and specificity levels.

Ethics approval

South East Research Ethics Committee approved on the 21/10/2009, ref: 09/H1102/62

Study design

Multicentre non-randomised study

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Acute liver failure

Intervention

This is a study of the MBT to assess liver function in patients with acute and/or chronic liver injury. All patients with acute liver disease meeting the inclusion/exclusion criteria will be accepted to this study. Patients will perform up to 7 tests; these may be performed in the course of a 21-day period, including days 0, 2, 4, 6, 10, 14, and 21.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To develop a model to predict deterioration of liver disease, which incorporates measurements from the MBT along with other potential variables. Tests will be performed in the course of a 21-day period or discontinued when the patient is discharged from hospital or if transplantation is undertaken or the patients' ongoing care is deemed futile and palliative care is being undertaken.

Secondary outcome measures

Safety evaluation through assessment of BreathID system (device and drug) related adverse events. Tests will be performed in the course of a 21-day period or discontinued when the patient is discharged from hospital or if transplantation is undertaken or the patients' ongoing care is deemed futile and palliative care is being undertaken.

Overall trial start date

02/11/2009

Overall trial end date

30/10/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult men or women (greater than 18 years of age)
2. Acute liver insult
3. No evidence of cirrhosis (unless clinical acute Wilsons)
4. International Normalised Ratio (INR) greater than 1.8
5. Duration of illness less than 12 or 24 weeks (to be determined [TBD])

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Any chronic liver disease
2. Severe congestive heart failure
3. Severe pulmonary hypertension
4. Chronic renal insufficiency with severe cardiac disease
5. Previous surgical bypass surgery for morbid obesity
6. Extensive small bowel resection
7. Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication
8. Recipient of any organ transplant
9. Proven or suspected hepatocellular carcinoma
10. Pregnant
11. Allergic to paracetamol (such as Tylenol® or any other related medications)
12. History of chronic obstructive pulmonary disease or symptomatic bronchial asthma
13. Septic cholestasis
14. Currently receiving total parenteral nutrition if they have contraindications to oral drugs
15. Taking hepatotoxin drugs
16. Hypersensitivity to paracetamol
17. Based on the opinion of the investigator, patient should not be enrolled into this study
18. Unable or unwilling to sign informed consent
19. Participating in other clinical trials evaluating experimental treatments or procedures

Recruitment start date

02/11/2009

Recruitment end date

30/10/2011

Locations

Countries of recruitment

Israel, United Kingdom, United States of America

Trial participating centre

King's College Hospital
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

Exalenz Bioscience Ltd (Israel)

Sponsor details

c/o Steven Eitan
4 Maayan
Modi'in
71700
Israel

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Exalenz Bioscience Ltd (Israel)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/04/2016: No publications found, verifying study status with principal investigator.