Hepatopulmonary SyndromePhase 2NCT00362752
A Pilot Study of Norfloxacin for Hepatopulmonary Syndrome
A Phase 2 study testing Norfloxacin in people with Hepatopulmonary Syndrome, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatopulmonary Syndrome
- What is being tested?
- Norfloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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):
- forced expiratory volume in 1 second (FEV1) less than 70 percent of predicted forced vital capacity (FVC) less than 70 percent of predicted FEV1/FVC less than 0.7 inability to perform pulmonary function tests (for the same reasons, it is important to document normal underlying lung function) echocardiographic estimated right ventricular systolic pressure 50 mm Hg or right heart catheterization mean pulmonary artery pressure greater than 25 mm Hg (pulmonary hypertension may result in progressive hypoxemia due to intracardiac shunt or right ventricular failure) inadequate echocardiographic window to allow for accurate transthoracic contrast (bubble) echocardiogram (CE) (this is the test used to identify IPVDs) antibiotic use within the last 1 month (this is the intervention being tested) (note that all subjects will be under the concurrent care of a gastroenterologist or hepatologist, and some patients may accordingly be on prophylactic antibiotic therapy for prior SBP or variceal hemorrhage; these patients will be excluded) (20 percent expected rate of exclusion due to this criterion) current use of exogenous nitrates (may increase exhaled NO levels) norfloxacin intolerance (norfloxacin administration is the study intervention): allergy or intolerance to norfloxacin or other fluoroquinolones history of tendon rupture associated with norfloxacin or other fluoroquinolones glucose 6-phosphate dehydrogenase deficiency (possibility of hemolytic reactions with norfloxacin) known prolongation of the QTc interval to a duration that is > 50% of the R-R interval, subjects taking QTc-interval prolonging drugs, subjects with uncorrected hypokalemia, clinically significant bradyarrhythmias or acute myocardial ischemia (norfloxacin may worsen this) pregnancy (norfloxacin contraindicated) age less than 18 or greater than 70 expected death/transplantation within 3 mo (treating physician's discretion) lactose intolerance (placebo contains lactose) Smoking within the last 1 month
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Research Question:
This is a pilot study; the fundamental research question is:
Does norfloxacin administration reduce Alveolar-arterial oxygen gradient (AaDO2) in patients with HPS and pre-HPS?
However, for this particular pilot study, the research question is:
What is the magnitude and standard deviation of the change in A-a gradient with norfloxacin treatment in subjects with HPS and pre-HPS ?
This is in order to enable accurate sample size estimations for a future large randomized-controlled trial of norfloxacin administration in the treatment of HPS and pre-HPS.
Significance:
HPS and pre-HPS is a disease that carries a high morbidity and an alarmingly high mortality. Orthotopic liver transplantation (OLT) is the only effective treatment, and in itself threatens a significant operative mortality in these patients.
A growing body of literature has built an elegant and compelling case for the role of gut bacterial translocation and secondary pulmonary nitric oxide (NO) overproduction in the pathophysiology of HPS.
A sophisticated rat model and a case report in a human subject have supported the potential for norfloxacin, a widely available, cheap and non-toxic antibiotic, to mitigate these effects and improve oxygenation, which is the most important contributor to both morbidity and mortality in HPS.
Given the dismal prognosis of this disease, the biological plausibility of the hypothesis, and the minimal foreseeable deleterious consequences of the intervention, it behooves the scientific community to formally test this theory.
- Objectives
- to evaluate the magnitude and standard deviation of the change in AaDO2 with norfloxacin treatment in subjects with HPS and pre-HPS, to enable accurate sample size estimations for a future large randomized-controlled trial of norfloxacin administration in the treatment of HPS
- to evaluate subject recruitment and retention, in order to determine the feasibility of a future large randomized-controlled trial of norfloxacin administration in the treatment of HPS and pre-HPS
- to qualitatively evaluate the usefulness of a number of new measures that have never been utilized in this subject population (baseline dyspnea index (BDI), transitional dyspnea index (TDI), Chronic Respiratory Disease Questionnaire (CRQ)
- to evaluate the hypothesized role of alveolar NO (measured by exhaled NO) as an intermediary in the relationship between norfloxacin administration and AaDO2
Methods
- Overview of Study Design - intervention and maneuver
This is a single-university center (University of Toronto), randomized, controlled pilot study with a crossover design. The intervention is exposure to norfloxacin (400 mg po bid) for a 4-week period, compared to an identical placebo treatment. In the crossover design, all subjects will receive both norfloxacin and the placebo medication, but the order of treatment will be randomized, as detailed in the study maneuver, below.
Study maneuver:
Eligible subjects will be identified by Drs. Faughnan and Gupta. They will subsequently be recruited by the respirology research coordinator (see details below). Next, the hospital pharmacist will provide each subject with a 4-week supply of either norfloxacin 400 mg po bid, or an identical placebo, according to the pre-determined computerized randomization scheme. The pharmacist will be the only person aware of the treatment allocation throughout the study (subjects, research coordinator, treating physicians and outcome assessors will be blinded). After the initial 4-week treatment, there will be a 4-week washout period, after which the pharmacist will provide each subject with a 4-week supply of the alternative agent (crossover) (see figure 2).
ii. Measurements - outcomes Outcomes
The primary endpoint in this study is the difference in the change in AaDO2 over the treatment course, between treatment and placebo groups. The secondary endpoints include partial pressure of arterial oxygen (paO2), exhaled NO, diffusion lung capacity for carbon monoxide (DLCO), cardiac output (CO), total peripheral resistance (TPR), pulmonary artery systolic pressure (PAP) (on echocardiogram), endotoxin levels, endothelin-1 (ET-1) levels, MELD score (model for end-stage liver disease) (based on creatinine, bilirubin and INR), baseline dyspnea index (BDI), transitional dyspnea index (TDI), and Chronic Respiratory Disease Questionnaire (CRQ).
Assessment of Outcomes Please see attached "procedure table," and "data collection sheet."
Once randomized, subjects will undergo initial assessment at time 0 (week 0), with:
- ABG (pO2, AaDO2)
- pulmonary function tests: exhaled NO, DLCO
- BP, echocardiogram: CO, TPR, PAP
- blood tests: INR, bilirubin, creatinine (MELD score), liver enzymes (ALT, AST, ALP, bilirubin), albumin, endotoxin level, ET-1 levels
- questionnaires: BDI/TDI, CRQ
- history and physical exam by study physician
All of these measures will be repeated after 4 weeks (end of first treatment course), 8 weeks (before start of next treatment course), and 12 weeks (end of second treatment course). In addition, ABG and exhaled NO alone will be repeated at 2 weeks and 10 weeks (midway through each treatment period). Finally, blood (40 ml) will be drawn at time 0, 4, 8, 12 weeks and stored for measurement of future variables.
- Conditions
- Hepatopulmonary Syndrome
- Being tested
- Norfloxacin, Placebo
- Keywords
- norfloxacin, hepatopulmonary syndrome
- Medical subject headings
- Hepatopulmonary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NorfloxacinDrug
400 mg po bid
PlaceboDrug
Placebo 400 mg po bid
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Norfloxacin 400 mg bid | Experimental | Not described Receives: Drug: Norfloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
- Primary endpoint: A-a gradient
Measured: 4 weeks
Secondary outcomes (14)
paO2,
Measured: 4 weeks
exhaled NO
Measured: 4 weeks
DLCO
Measured: 4 weeks
6MWD
Measured: 4 weeks
CO
Measured: 4 weeks
TPR
Measured: 4 weeks
PAP (on echocardiogram)
Measured: 4 weeks
endotoxin levels
Measured: 4 weeks
ET-1 levels
Measured: 4 weeks
MELD score
Measured: 4 weeks
bilirubin and INR
Measured: 4 weeks
BDI
Measured: 4 weeks
TDI
Measured: 4 weeks
CRQ
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2006 (estimated)
- Study startOct 2006
- Primary completionJan 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatopulmonary SyndromeStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Marie Faughnan, Unity Health Toronto
- Investigators
- Marie Faughnan, MD MSc FRCPC, Principal investigator, St. Michael's Hospital, Toronto Canada; University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00362752
- Sponsor's protocol ID
- 02-120
- Status last verified
- Dec 2016
- First submitted
- 8 Aug 2006
- Last updated
- 7 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20816858
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Norfloxacin for Hepatopulmonary Syndrome
- ClinicalTrials.gov ID
- NCT00362752
- Acronym / sponsor ID
- 02-120
- Conditions
- Hepatopulmonary Syndrome
- Keywords
- norfloxacin, hepatopulmonary syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Oct 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 10 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research Question:
This is a pilot study; the fundamental research question is:
Does norfloxacin administration reduce Alveolar-arterial oxygen gradient (AaDO2) in patients with HPS and pre-HPS?
However, for this particular pilot study, the research question is:
What is the magnitude and standard deviation of the change in A-a gradient with norfloxacin treatment in subjects with HPS and pre-HPS ?
This is in order to enable accurate sample size estimations for a future large randomized-controlled trial of norfloxacin administration in the treatment of HPS and pre-HPS.
Significance:
HPS and pre-HPS is a disease that carries a high morbidity and an alarmingly high mortality. Orthotopic liver transplantation (OLT) is the only effective treatment, and in itself threatens a significant operative mortality in these patients.
A growing body of literature has built an elegant and compelling case for the role of gut bacterial translocation and secondary pulmonary nitric oxide (NO) overproduction in the pathophysiology of HPS.
A sophisticated rat model and a case report in a human subject have supported the potential for norfloxacin, a widely available, cheap and non-toxic antibiotic, to mitigate these effects and improve oxygenation, which is the most important contributor to both morbidity and mortality in HPS.
Given the dismal prognosis of this disease, the biological plausibility of the hypothesis, and the minimal foreseeable deleterious consequences of the intervention, it behooves the scientific community to formally test this theory.
- Objectives
- to evaluate the magnitude and standard deviation of the change in AaDO2 with norfloxacin treatment in subjects with HPS and pre-HPS, to enable accurate sample size estimations for a future large randomized-controlled trial of norfloxacin administration in the treatment of HPS
- to evaluate subject recruitment and retention, in order to determine the feasibility of a future large randomized-controlled trial of norfloxacin administration in the treatment of HPS and pre-HPS
- to qualitatively evaluate the usefulness of a number of new measures that have never been utilized in this subject population (baseline dyspnea index (BDI), transitional dyspnea index (TDI), Chronic Respiratory Disease Questionnaire (CRQ)
- to evaluate the hypothesized role of alveolar NO (measured by exhaled NO) as an intermediary in the relationship between norfloxacin administration and AaDO2
Methods
- Overview of Study Design - intervention and maneuver
This is a single-university center (University of Toronto), randomized, controlled pilot study with a crossover design. The intervention is exposure to norfloxacin (400 mg po bid) for a 4-week period, compared to an identical placebo treatment. In the crossover design, all subjects will receive both norfloxacin and the placebo medication, but the order of treatment will be randomized, as detailed in the study maneuver, below.
Study maneuver:
Eligible subjects will be identified by Drs. Faughnan and Gupta. They will subsequently be recruited by the respirology research coordinator (see details below). Next, the hospital pharmacist will provide each subject with a 4-week supply of either norfloxacin 400 mg po bid, or an identical placebo, according to the pre-determined computerized randomization scheme. The pharmacist will be the only person aware of the treatment allocation throughout the study (subjects, research coordinator, treating physicians and outcome assessors will be blinded). After the initial 4-week treatment, there will be a 4-week washout period, after which the pharmacist will provide each subject with a 4-week supply of the alternative agent (crossover) (see figure 2).
ii. Measurements - outcomes Outcomes
The primary endpoint in this study is the difference in the change in AaDO2 over the treatment course, between treatment and placebo groups. The secondary endpoints include partial pressure of arterial oxygen (paO2), exhaled NO, diffusion lung capacity for carbon monoxide (DLCO), cardiac output (CO), total peripheral resistance (TPR), pulmonary artery systolic pressure (PAP) (on echocardiogram), endotoxin levels, endothelin-1 (ET-1) levels, MELD score (model for end-stage liver disease) (based on creatinine, bilirubin and INR), baseline dyspnea index (BDI), transitional dyspnea index (TDI), and Chronic Respiratory Disease Questionnaire (CRQ).
Assessment of Outcomes Please see attached "procedure table," and "data collection sheet."
Once randomized, subjects will undergo initial assessment at time 0 (week 0), with:
- ABG (pO2, AaDO2)
- pulmonary function tests: exhaled NO, DLCO
- BP, echocardiogram: CO, TPR, PAP
- blood tests: INR, bilirubin, creatinine (MELD score), liver enzymes (ALT, AST, ALP, bilirubin), albumin, endotoxin level, ET-1 levels
- questionnaires: BDI/TDI, CRQ
- history and physical exam by study physician
All of these measures will be repeated after 4 weeks (end of first treatment course), 8 weeks (before start of next treatment course), and 12 weeks (end of second treatment course). In addition, ABG and exhaled NO alone will be repeated at 2 weeks and 10 weeks (midway through each treatment period). Finally, blood (40 ml) will be drawn at time 0, 4, 8, 12 weeks and stored for measurement of future variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Norfloxacin 400 mg bid | Experimental | Drug: Norfloxacin |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- 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
Key exclusion criteria (2 listed)
- 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):
- forced expiratory volume in 1 second (FEV1) less than 70 percent of predicted forced vital capacity (FVC) less than 70 percent of predicted FEV1/FVC less than 0.7 inability to perform pulmonary function tests (for the same reasons, it is important to document normal underlying lung function) echocardiographic estimated right ventricular systolic pressure 50 mm Hg or right heart catheterization mean pulmonary artery pressure greater than 25 mm Hg (pulmonary hypertension may result in progressive hypoxemia due to intracardiac shunt or right ventricular failure) inadequate echocardiographic window to allow for accurate transthoracic contrast (bubble) echocardiogram (CE) (this is the test used to identify IPVDs) antibiotic use within the last 1 month (this is the intervention being tested) (note that all subjects will be under the concurrent care of a gastroenterologist or hepatologist, and some patients may accordingly be on prophylactic antibiotic therapy for prior SBP or variceal hemorrhage; these patients will be excluded) (20 percent expected rate of exclusion due to this criterion) current use of exogenous nitrates (may increase exhaled NO levels) norfloxacin intolerance (norfloxacin administration is the study intervention): allergy or intolerance to norfloxacin or other fluoroquinolones history of tendon rupture associated with norfloxacin or other fluoroquinolones glucose 6-phosphate dehydrogenase deficiency (possibility of hemolytic reactions with norfloxacin) known prolongation of the QTc interval to a duration that is > 50% of the R-R interval, subjects taking QTc-interval prolonging drugs, subjects with uncorrected hypokalemia, clinically significant bradyarrhythmias or acute myocardial ischemia (norfloxacin may worsen this) pregnancy (norfloxacin contraindicated) age less than 18 or greater than 70 expected death/transplantation within 3 mo (treating physician's discretion) lactose intolerance (placebo contains lactose) Smoking within the last 1 month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Norfloxacin400 mg po bid | Drug | Norfloxacin 400 mg bid |
| PlaceboPlacebo 400 mg po bid | Drug | Placebo |
Primary outcome
- Primary endpoint: A-a gradient
Time frame: 4 weeks
14 secondary outcomes
paO2,
Time frame: 4 weeks
exhaled NO
Time frame: 4 weeks
DLCO
Time frame: 4 weeks
6MWD
Time frame: 4 weeks
CO
Time frame: 4 weeks
TPR
Time frame: 4 weeks
PAP (on echocardiogram)
Time frame: 4 weeks
endotoxin levels
Time frame: 4 weeks
ET-1 levels
Time frame: 4 weeks
MELD score
Time frame: 4 weeks
bilirubin and INR
Time frame: 4 weeks
BDI
Time frame: 4 weeks
TDI
Time frame: 4 weeks
CRQ
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2016.
- Results publication: PubMed 20816858Gupta 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.
- Norfloxacin therapy for hepatopulmonary syndrome: a pilot randomized controlled trialLink provided by the sponsor.
Related trials for Hepatopulmonary Syndrome
Enrolling by invitationObservational study
International Registry of Congenital Portosystemic Shunt (IRCPSS)
Congenital Portosystemic Shunt, CPSS (Congenital Portosystemic Shunt)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Faughnan, MD MSc FRCPC principal investigator
St. Michael's Hospital, Toronto Canada; University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Norfloxacin in people with Hepatopulmonary Syndrome, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
- Primary endpoint: A-a gradient (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00362752, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.