NCT00005107

Brief Summary

This study is to determine whether a compound, nitric oxide, made within the body, is the factor responsible for the changes in blood pressure and renal (kidney) functions that may occur during the course of cirrhosis. Patients with cirrhosis (liver scarring which causes poor liver function) will be eligible to participate. A group of healthy subjects will also be studied to compare the effects of the treatment to patients with cirrhosis and to confirm safety. A total number of 30 patients with cirrhosis and 10 healthy subjects will be enrolled in the study.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 12, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

April 11, 2000

Last Update Submit

June 23, 2005

Conditions

CirrhosisLiver Cirrhosis

Interventions

N-monomethyl-L-arginineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with compensated cirrhosis without previous history of ascites or edema
  • Cirrhotic patient with ascites without renal failure
  • Cirrhotic patients with ascites with functional renal failure
  • Age and sex-matched healthy subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

4200 E. Ninth Ave., Box C281

Denver, Colorado, 80262, United States

RECRUITING

MeSH Terms

Conditions

FibrosisLiver Cirrhosis

Interventions

omega-N-Methylarginine

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ArginineAmino Acids, BasicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DiaminoAmino Acids, Essential

Central Study Contacts

Chiraq Parikh, M.D.

CONTACT

1-303-266-0771

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

April 11, 2000

First Posted

April 12, 2000

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations

US(1)