Pilot multicenter open label study on treatment with Sofosbuvir/Ledipasvir FDC for patients with thalassemia major and HCV infection.
- Conditions
- Patients with thalassemia major and HCV infection either naïve or on nucleo(s)tide analogs treatment, data on Sofosbuvir-based treatment are currently lacking, while, due to the long infection duration, this category of patients has a urgent treatment need.MedDRA version: 20.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-002401-10-IT
- Lead Sponsor
- FONDAZIONE CASA SOLLIEVO DELLA SOFFERENZA OPERA DI SAN PIO DA PIETRELCINA OSPEDALE IRCCS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 100
oPatients >18 years; HCV RNA-positive and HCV Ab positive, HBsAg negative, genotype 1 or 4 infected; Naïve or prior treatment failure.
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 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
oHIV co-infected patients;
oHBsAg /HDV co-infected
oCreatinine clearance 50 ml/min
oPLT < 90.000/mm3;
oHCC and other neoplasia;
oPregnancy;
oBreastfeeding
oPatients with Child Pugh > B7;
oPatients with AFP levels higher than 40.
oChronic liver diseases other than HCV such as but not limited to: hemocromatosis, autoimmune hepatitis, metabolic liver diseases, alcoholic liver diseases, toxin exposure),
oPatients with severe or uncontrolled cardiac disease during the previous 24 weeks,
oPatients with debilitating diseases.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method