Brain Muscle Axis During Treatment of Hepatic Encephalopathy With L-ornithine L-aspartate

PHASE4CompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

August 31, 2013

Primary Completion Date

June 30, 2015

Study Completion Date

June 30, 2015

Conditions
Hepatic EncephalopathyMinimal Hepatic EncephalopathyCirrhosis
Interventions
PROCEDURE

Vastus Muscle Biopsy

Both Arms, all 3 visits at 0, 4 and 12 weeks

DRUG

LOLA or placebo

Hepa-Merz Granulat 3000 Hepa-Merz granules 3g (Each 5g sachet contains 3g of L-ornithine L-aspartate) L-ornithine L-aspartate LOLA Randomised to a daily dose 18g per day, two sachets of Hepa-Merz granules three times a day (or placebo)for 12 weeks

OTHER

Cognitive assessment (PHES)

Both Arms, all 3 visits at 0, 4 and 12 weeks

OTHER

Cognitive Assessement (Cogstate)

Both Arms, all 3 visits at 0, 4 and 12 weeks

OTHER

blood and urine sampling

Both Arms, all 3 visits at 0, 4 and 12 weeks

OTHER

Nutritional assessment

Both Arms, all 3 visits at 0, 4 and 12 weeks

OTHER

MRI brain and spectroscopy

Both Arms, all 3 visits at 0, 4 and 12 weeks

OTHER

MRI leg cross section

Both Arms, all 3 visits at 0, 4 and 12 weeks

OTHER

Functional MRI (working memory and attention tasks)

Both Arms, all 3 visits at 0, 4 and 12 weeks

Trial Locations (1)

W2 1NY

Liver unit St Mary's Hospital, 10th floor QEQM Wing, South Wharf Road, London

All Listed Sponsors
lead

Imperial College London

OTHER

NCT01847651 - Brain Muscle Axis During Treatment of Hepatic Encephalopathy With L-ornithine L-aspartate | Biotech Hunter | Biotech Hunter