A Pilot Study of Norfloxacin for Hepatopulmonary Syndrome

NCT00362752 | Completed Phase 2

• 1 other identifier: 02-120
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The hepatopulmonary syndrome (HPS)and pre-HPS is a disease seen in patients with chronic liver disease, whereby patients develop dilations in the blood vessels of the lungs, resulting in low oxygen levels and shortness of breath. In this study, each HPS and pre-HPS subject will be treated with a commonly used antibiotic called "norfloxacin" (approved for use in the treatment of gonorrhea, prostatitis and urinary tract infections) for a 4-week period. In order to ensure that any observed improvement was indeed due to norfloxacin, each subject will also be treated with a separate 4-week course of an identical placebo. There will also be a 4 week wash-out period (no study medication/placebo) between the 2 courses of treatment. The primary aim of the study will be to measure improvements in oxygen levels while on norfloxacin, although a number of secondary parameters will also be followed.

Conditions

Hepatopulmonary Syndrome

Keywords

norfloxacin; hepatopulmonary syndrome

Outcome Measures

Primary Outcomes (1)

• - Primary endpoint: A-a gradient

  4 weeks

Secondary Outcomes (14)

• paO2,

  4 weeks

• exhaled NO

  4 weeks

• DLCO

  4 weeks

• 6MWD

  4 weeks

• CO

  4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Norfloxacin 400 mg bid

EXPERIMENTAL

Drug: Norfloxacin

Interventions

Norfloxacin DRUG

400 mg po bid

Norfloxacin 400 mg bid

Placebo DRUG

Placebo 400 mg po bid

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of HPS, based on all of the following:
• evidence of portal hypertension (esophagogastric varices or portal hypertensive gastropathy identified on esophagogastroduodenoscopy, and/or varices seen on computerized tomography (CT) scan or ultrasound, and/or splenomegaly with no other explanation, and/or ascites with no other explanation, and/or hepatic vein wedge pressure greater than 12 mm Hg) Intrapulmonary shunt on contrast echocardiography (CE) AaDO2 greater than 20 mm Hg on standing, room air arterial blood gas (ABG) OR
• Pre-HPS with elevated exhaled Nitric Oxide:
• evidence of portal hypertension (esophagogastric varices or portal hypertensive gastropathy identified on esophagogastroduodenoscopy, and/or varices seen on computerized tomography (CT) scan or ultrasound, and or splenomegaly with no other explanation, and/or ascites with no other explanation, and/or hepatic vein wedge pressure greater than 12 mm Hg) IPVDs diagnosed on contrast echocardiography (CE) exhaled nitric oxide level greater than 12.6 ppb

You may not qualify if:

• Significant pre-existing respiratory disease (in these cases, the diagnosis of HPS or pre-HPS is uncertain, given that observed elevations in AaDO2 may be from underlying lung disease):

Sponsors & Collaborators

• Unity Health Toronto: lead
• University of Toronto: collaborator

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (1)

• Gupta S, Faughnan ME, Lilly L, Hutchison S, Fowler R, Bayoumi AM. Norfloxacin therapy for hepatopulmonary syndrome: a pilot randomized controlled trial. Clin Gastroenterol Hepatol. 2010 Dec;8(12):1095-8. doi: 10.1016/j.cgh.2010.08.011. Epub 2010 Nov 9.

  PMID: 20816858 RESULT

Related Links

• Norfloxacin therapy for hepatopulmonary syndrome: a pilot randomized controlled trial

MeSH Terms

Conditions

Hepatopulmonary Syndrome

Interventions

Norfloxacin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Marie Faughnan, MD MSc FRCPC

  St. Michael's Hospital, Toronto Canada; University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: August 8, 2006
• First Posted: August 10, 2006
• Study Start: October 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 7, 2016

Record last verified: 2016-12

Locations

CA (1)