EUCTR2011-005643-26-IT
Active, Not Recruiting
N/A
Cross-over pharmacokinetic study and pharmacodynamics of 2 different folate (5-MTHF and folic acid) in patients with liver cirrhosis with viral etiology. A randomized, open-label trial. - PrefoCir2
ZAMBON ITALIA0 sitesMarch 29, 2012
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ZAMBON ITALIA
- Status
- Active, Not Recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 3
A Randomized, Crossover, Pharmacokinetic and Pharmacodynamic Study to Determine the Safety and Efficacy of Cysteamine Bitartrate Delayed-release Capsules (RP103), Compared to Cystagon® in Patients with Nephropathic Cystinosismetabolic disorder in which the transport of cystine out of the lysosomes is abnormalNephropathic cystinosis10000546NL-OMON34074Raptor Pharmaceuticals Europe BV5
Active, Not Recruiting
Phase 1
A Randomized, Crossover, Pharmacokinetic and PharmacodynamicStudy to Determine the Safety and Efficacy of Cysteamine BitartrateDelayed-release Capsules (RP103), Compared to Cystagon® in Patientswith Nephropathic CystinosisEUCTR2009-017882-42-FRRaptor Therapeutics Inc.
Active, Not Recruiting
N/A
A Randomized, Crossover, Pharmacokinetic and PharmacodynamicStudy to Determine the Safety and Efficacy of Cysteamine BitartrateDelayed-release Capsules (RP103), Compared to Cystagon® in Patientswith Nephropathic CystinosisCystinosisMedDRA version: 12.1Level: LLTClassification code 10011777Term: CystinosisEUCTR2009-017882-42-NLRaptor Therapeutics Inc.20
Completed
N/A
Comparative pharmacokinetics, pharmacodynamics, efficacy and safety of two asparaginase preparations in children with previously untreated acute lymphoblastic leukaemia (ALL)ISRCTN75734403Medac GmbH (Germany)32
Completed
Phase 4
A study on pharmacokinetics (fate of drug in the body) of single oral dose of 15mg and 45 mg Primaquine in healthy human volunteersCTRI/2011/06/001803I12