PrefoCir2, pharmacokinetics and pharmacodynamics of folate in patients with cirrhosis

• Conditions: In all cases of folate deficiency due to increased demand, poor absorption, inadequate dietary intake and reduced utilization of the vitamin in patients with viral liver cirrhosis.; MedDRA version: 14.1Level: LLTClassification code 10047457Term: Viral hepatitis CSystem Organ Class: 10021881 - Infections and infestations; MedDRA version: 14.1Level: LLTClassification code 10047450Term: Viral hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-005643-26-IT
• Lead Sponsor: ZAMBON ITALIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-29
• Last Update Posted: 14 October 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients with confirmed diagnosis of liver cirrhosis with viral etiology Age between 18 and 70 years Consent to participate in the study and willingness to submit to visits by the Protocol
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2

Exclusion Criteria

Women who are pregnant or lactating Presence of cancer at enrollment or within five years preceding Presence of gastrointestinal bleeding or episodes that occurred in the four weeks prior to enrollment transplant patients Patients who have ongoing treatment with immunosuppressive or interferon Patients with a BMI more than 30 or less than 18 Patients in chronic therapy with folate, or medications / supplements containing B vitamins

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified