NCT05508633Enrolling by invitationPhase 2
The Instant Efficacy and Safety of Alverine in Decreasing Portal Hypertension: an Exploratory Pilot Study
Source: ClinicalTrials.gov · Last updated 25 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The main purpose of this exploratory study was to investigate the instant efficacy and safety of alverine oral administration in decreasing portal hypertension. Condition of disease: Cirrhotic portal hypertension Intervention/treatment: Drug: Alverine 60 mg (1 capsule), orally Drug: Alverine 120 mg (2 capsules), orally
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- First submitted
- 18 Aug 2022
- Start date
- 28 Oct 2022
- Primary completion date
- Dec 2025
- Lead sponsor
- Shanghai Changzheng Hospital
- Diseases
- High blood pressure
- NCT number
- NCT05508633
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 20
- From 28 Oct 2022 to the primary completion date, Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of non-selective beta-blockers (e.g. carvedilol, propranolol) or statins within 1 month prior to dosing.
- Previous splenectomy, cardia periesophageal vascular dissection, transjugular intrahepatic portosystemic shunt (TIPS), liver transplantation, etc.
- Any uncontrolled active infection (e.g. lung infection, abdominal infection, HIV, etc) 4 weeks prior to enter in the study.
- Patients with abnormal mental symptoms or taking tricyclic antidepressants and similar drugs in the past 4 weeks.
Other illness
- Moderate or massive ascites, overt hepatic encephalopathy, gastrointestinal bleeding and other complications within 1 week.
- Presence of hepatic vein, portal vein, splenic vein thrombosis or cavernous transformation of the portal vein.
- Poorly controllable hypertension or diabetic patient; severe background disease like chronic respiratory failure, circulatory failure, kidney failure etc.
- Clinically diagnosed or suspected as malignancy, including hepatocellular carcinoma.
- Patient who are allergy to the experimental drug.
Lab values
- Coagulopathy, including platelet count \< 50× 10\^9/ L, international normalized ratio (INR) of prothrombin time ≥1.5.
- Serum total bilirubin ≥ 5 fold of upper limits of normal; serum sodium level \< 125 mmol/ L; white blood cell count \< 1× 10\^9/ L.
- Severe chronic renal insufficiency (eGFR (CKD-EPI) \< 20 ml/min/1.73 m2).
Other
- Gestation or lactation period women and women who plan to get pregnant during the study period.
- Patients who are participating other trials or have taken part in other in the past 4 weeks.
- Other situation where PI thinks the patient should be excluded.
Who the study is looking for
- Age 18-75 years.
- Confirmed evidence of cirrhosis/ Cirrhosis diagnosed by liver biopsy or by imaging studies showing a nodular liver, splenomegaly and/or collateral.
- Portal pressure greater than equal to (≥)10 mmHg.
- Signed informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Changzheng Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.