Pilot multicenter open label study on treatment with Sofosbuvir/Ledipasvir FDC for patients with thalassemia major and HCV infection.

Pilot multicenter open label study on treatment with Sofosbuvir/Ledipasvir FDC for patients with thalassemia major and HCV infection. - Pilot multicenter open label study on treatment with Sofosbuvir/Ledipasvir FDC for patients with tha

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002401-10-IT

Enrollment

100

Registered

2021-09-10

Start date

2015-10-12

Completion date

Unknown

Last updated

2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: HARVONI - 90 MG/400 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - FLACONE (HDPE) - 28 COMPRESSE RIVESTITE CON FILM Product Name: HARVONI Product Code: 700016355 Pharmaceutical Form: Fil

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: o Patients >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

Exclusion criteria

Exclusion criteria: o HIV co-infected patients; o HBsAg /HDV co-infected o Creatinine clearance 50 ml/min o PLT B7; o Patients with AFP levels higher than 40. o Chronic liver diseases other than HCV such as but not limited to: hemocromatosis, autoimmune hepatitis, metabolic liver diseases, alcoholic liver diseases, toxin exposure), o Patients with severe or uncontrolled cardiac disease during the previous 24 weeks, o Patients with debilitating diseases.

Design outcomes

Primary

Measure	Time frame
Main Objective: Efficacy and safety of SOF/LDV without RBV in patients with HCV GT1 or 4 and thalassemia major;Secondary Objective: NA;Primary end point(s): •Post-treatment sustained virological response (pTVR): SVR12.;Timepoint(s) of evaluation of this end point: 24 weeks	—

Secondary

Measure	Time frame
Secondary end point(s): • Number of patients developing side effects while on treatment.leading to treatment discontinuation;Timepoint(s) of evaluation of this end point: 24 weeks	—

Countries

Italy

Contacts

Public ContactANNAMARIA CIACCIO

IRCCS OSPEDALE CASA SOLLIEVO DELLA SOFFERENZA DI SAN GIOVANNI ROTONDO

comitatoetico@operapadrepio.it+390882410831

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026