Overview

Phase 1 Study of L-NMMA in Patients With Liver Cirrhosis

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
Summary
Phase 1 study of the effects of nitric oxide inhibition with L-NMMA in patients with liver cirrhosis and healthy controls. It is hypothesized that nitric oxide availability is increased in liver cirrhosis.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Regional Hospital Holstebro
Treatments:
omega-N-Methylarginine
Criteria
Inclusion Criteria:

Healthy controls

- Age 20 to 60 years

- Both men and women

- Weight below 100 kg

- Normal clinical examination and laboratory screening

- Fertile women only if using contraception

- Informed consent according to the regulations of the local ethics committee

Liver cirrhosis

- Biopsy verified liver cirrhosis or clinical and laboratory signs of liver cirrhosis
including hypoalbuminaemia, increased prothrombin time in combination with
esophagusvarices or ascites

- P-creatinine < 250 µmol/L

- Age 20-60 years

- Both men and women

- Fertile women only if using contraception

- Body weight below 100 kg

- Informed consent according to the regulations of the local ethics committee

Exclusion Criteria:

Healthy controls

- History or clinical evidence of diseases of the heart and blood vessels, kidneys,
liver and pancreas, endocrine organs, lungs, neoplastic disease, myocardial infarction
or cerebrovascular insult as evaluated by clinical examination and laboratory
screening

- Current medication

- Drugs or alcohol abuse

- Pregnancy

- Previously within one year received more than 0.2 mSV radioactive treatment or
diagnostic substances

- Donation of blood less than 1 month before the experiments

Liver cirrhosis

- Apart from liver cirrhosis no history of diseases of the heart and blood vessels,
endocrine organs, lungs, myocardial infarction, cerebrovascular insult or neoplastic
disease.

- Drugs or alcohol abuse

- Pregnancy

- Previously within one year received more than 0.2 mSV radioactive treatment or
diagnostic substances