5-Metyl-tetrahydrofolate in the treatment of portal hypertension in cirrhotics in pharmacologic prophylaxis of variceal bleeding with beta-blockers: a double-blind randomized controlled trial

Phase 1

Conditions: portal hypertension in cirrhotic patients
MedDRA version: 17.0Level: HLTClassification code 10036201Term: Portal hypertensionsSystem Organ Class: 100000004866
MedDRA version: 17.0Level: LLTClassification code 10009211Term: Cirrhosis liverSystem Organ Class: 100000004871
Therapeutic area: Not possible to specify

Registration Number: EUCTR2014-002018-21-IT

Lead Sponsor: AOU di Bologna Policlinico S.Orsola-Malpighi

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 60

Inclusion Criteria

Liver cirrhosis demonstrated in terms of clinical, biochemical, imaging (echo-doppler upper abdomen, liver elastography). In the case of doubtful diagnosis is scheduled to run hepatic histology
• HVPG = 12 mmHg
• Presence of esophageal varices requiring the prophylaxis of bleeding from rupture (as indicated by guidelines Baveno V [7])
• Aged between 18 and 80 years
• Females and males
• Signature of informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Presence of HCC at the time of enrollment or within 3 months prior
• The presence of portal vein thrombosis at the time of enrollment or within 3 months prior
• Presence of acute infections or conditions compromising hemodynamic stability at the time of enrollment or during the previous month
• Serum creatinine> 2.5 mg / dL at enrollment
• Direct bilirubin> 6 mg / dL at enrollment
• Contraindications to beta-blockers at enrollment
• Women who are pregnant and / or lactating at the time of enrollment
• Known or suspected hypersensitivity to the drug or drug class in studio
• Patients with serious medical conditions at enrollment who, in the opinion of the investigator, contraindicate the patient's participation in the study
• Use of experimental drugs in the last 3 months before inclusion in the study
• Treatment for hepatitis C in place at the time of study or in the previous 3 months
• Treatment for hepatitis B undertaken by less than 3 months at the time of enrollment