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: 14.1 Level: LLT Classification code 10047457 Term: Viral hepatitis C System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 10047450 Term: Viral hepatitis B System Organ Class: 10021881 - Infections and infestations
Conditions
Sponsors
ZAMBON ITALIA
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate, through a feasibility study, the pharmacokinetic characteristics in terms of absorption, distribution, metabolism of the active form of folate (5-MTHF) and of the inactive form (folic acid), in patients with viral liver cirrhosis related to severity of the disease.;Secondary Objective: Evaluation of folates (total plasma, circulating and intraerythrocytic), hemoglobin, MCV and homocysteine ??in patients with liver cirrhosis after long-term (8 weeks) administration of 5-MTHF or folic acid. Evaluation of 5-MTHF and folic acid pharmacokinetics in patients with liver cirrhosis in relation to severity of portal hypertension. Evaluation of folate levels correlating with MTHFR possible mutation and concomitant therapies. Evaluation of the correlation between values ??of hemoglobin, MCV and homocysteine ??with folate levels (total plasma, circulating and intraerythrocytic) in patients with liver cirrhosis.;Primary end point(s): Evaluate, through a feasibility study, the pharmacokinetic characteristics in terms of absorption, distribution, metabolism of the active form of folate (5-MTHF) and of the inactive form (folic acid), in patients with viral liver cirrhosis related to severity of the disease.;Timepoint(s) of evaluation of this end point: After single dose administration, in the following 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluation of folates (total plasma, circulating and intraerythrocytic), hemoglobin, MCV and homocysteine ??in patients with liver cirrhosis after long-term (8 weeks) administration of 5-MTHF or folic acid. Evaluation of 5-MTHF and folic acid pharmacokinetics in patients with liver cirrhosis in relation to severity of portal hypertension. Evaluation of folate levels correlating with MTHFR possible mutation and concomitant therapies. Evaluation of the correlation between values ??of hemoglobin, MCV and homocysteine ??with folate levels (total plasma, circulating and intraerythrocytic) in patients with liver cirrhosis.;Timepoint(s) of evaluation of this end point: At baseline, in the 24 hours following one single dose administration, and after 8 weeks of long-term administration | — |
Countries
Italy
Contacts
Public Contactdivisione di emmedi srl
SOLARIS
Outcome results
None listed