NOPE Study
EU CTIS ID: 2024-513352-15-00
What this study is testing
To assess whether treatment with norfloxacin leads to a decrease in portal hypertension (PH) as evaluated by hepatic venous pressure gradient (HVPG) after 12 weeks in patients with decompensated cirrhosis (dACLD).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients with dACLD undergoing liver vein catheterization for measurement of hepatic venous pressure gradient
- Age 18-80 years
- Written informed consent to participate in the study
You likely can't join if
- Lack of ability to give consent or unwillingness to participate in the study
- Pregnancy or unwillingness to utilize effective means of contraception for the duration of the study in women of childbearing potential
- QTc >480 ms at study screening
- Serum creatinine >1.5 mg/dL at study screening or chronic hemodialysis
- Bilirubin >5 mg/dL at study screening
- High paracentesis frequency
See the full eligibility criteria
- Patients with dACLD undergoing liver vein catheterization for measurement of hepatic venous pressure gradient
- Age 18-80 years
- Written informed consent to participate in the study
- Lack of ability to give consent or unwillingness to participate in the study
- Pregnancy or unwillingness to utilize effective means of contraception for the duration of the study in women of childbearing potential
- QTc >480 ms at study screening
- Serum creatinine >1.5 mg/dL at study screening or chronic hemodialysis
- Bilirubin >5 mg/dL at study screening
- High paracentesis frequency
- Initiation of hepatitis C virus (HCV) or hepatitis B virus (HBV) treatment within the last year
- Non-cirrhotic portal hypertension (e.g. PSVD)
- Malignant diseases including hepatocellular carcinoma (HCC) at enrollment
- Immunosuppression
- Untreated/uncontrolled HIV infection
- Long-term administration of antibiotic medication at study enrollment
- Allergy to norfloxacin or other quinolones
- Risk of incompliance/lack of adherence to the study protocol (at the investigator’s discretion)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.