Single arm prospective clinical study to evaluate the efficacy of combination therapy sofosbuvir+ribavirin+peg-interferon in experienced patients with HCV-GT1

Single arm prospective clinical study to evaluate the efficacy of combination therapy sofosbuvir+ribavirin+peg-interferon in experienced patients with HCV-GT1 - IN-US-334-0141 - SOF

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005388-34-IT

Enrollment

Unknown

Registered

2016-09-29

Start date

2015-05-20

Completion date

Unknown

Last updated

2016-10-03

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

Conditions

chronic hepatitis HCV GT1 who have already failed a prior course of dual therapy with pegylated interferon + ribavirin MedDRA version: 19.0 Level: HLT Classification code 10057212 Term: Hepatitis viral infections System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: SOVALDI - 400 MG - COMPRESSA RIVESTITA CON FILM - FLACONE (HDPE) - 28 COMPRESSE Product Name: SOVALDI Product Code: 043196 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: SOFO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Subjects, male or female, aged> 18 years. 2. Subjects infected with HCV genotype 1 chronic hepatitis or compensated cirrhosis (Child A). 3. Previous treatment with dual therapy (pegylated interferon + ribavirin) without obtaining SVR (relapsers, partial, null responders). 4. Positivity for serum HCV-RNA. 5. Evaluation recent (within 6 months) the degree of liver fibrosis with validated method (biopsy or Fibroscan). 6. Informed consent form with signed and dated 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) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

Exclusion criteria: 1. decompensated liver disease, or a history of heart failure, ascites, encephalopathy, HCC. 2. Inadequate tolerability ribavirin and/or pegylated interferon therapy during the previous attempt. 3. Any known contraindication to ribavirin and / or pegylated interferon and / or Sofosbuvir. 4. Any severe comorbidities that in the opinion of Clinical Researcher may compromise the safety of the treatment. 5. Pregnancy ongoing or breastfeeding. Pregnancy is highly NOT recommended in these patients, and if it is programmed patients are excluded from the study. If sexually active, patients should use an effective method of birth control. 6. Other concomitant treatment against viral hepatitis HCV. 7. Patients taking medications that interfere with ribavirin, pegylated interferon and Sofosbuvir (cytochrome P450, azathioprine, methadone, telbivudine and anti-HIV agents).

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy, as virological response at 12 weeks after the end of treatment (SVR-12), of the combined therapy Sofosbuvir + Ribavirin + pegylated interferon in patients with chronic hepatitis HCV genotype 1 who have failed a prior course of treatment with ribavirin and interferon alpha, assuming the achievement of an effectiveness of 71% according to what is predicted by the model FDA;Secondary Objective: Evaluate the effectiveness (SVR-12) of the combined treatment Sofosbuvir + pegylated interferon + ribavirin in relation to the viral response to the previous cycle of dual therapy (null-response, relapsers, partial responders). • Evaluate the effectiveness (SVR-12) of the combined treatment Sofosbuvir + pegylated interferon + ribavirin in relation to the stage of liver disease (defined as METAVIR fibrosis stage) and the presence or absence of cirrhosis. • Confirm the safety profile and tolerability of the combined treatment Sofosbuvir + pegylated interferon + ribavirin in patients with chronic hepatitis HCV genotype 1 who have failed at least six months a previous course of treatment with ribavirin and pegylated interferon and which do not show contraindications to the use of pegylated interferon and ribavirin. • Evaluate the proportion of interruption of the course of treatment due to adverse events;Primary end point(s): virological response at 12 weeks after the end of treatment (proportion of SVR-12, or negative viremia) of combination therapy pegylated interferon + ribavirin + Sofosbuvir;Timepoint(s) of evaluation of this end point: at 12 weeks after the end of treatment	—

Measure

Time frame

Main Objective: To evaluate the efficacy, as virological response at 12 weeks after the end of treatment (SVR-12), of the combined therapy Sofosbuvir + Ribavirin + pegylated interferon in patients with chronic hepatitis HCV genotype 1 who have failed a prior course of treatment with ribavirin and interferon alpha, assuming the achievement of an effectiveness of 71% according to what is predicted by the model FDA;Secondary Objective: Evaluate the effectiveness (SVR-12) of the combined treatment Sofosbuvir + pegylated interferon + ribavirin in relation to the viral response to the previous cycle of dual therapy (null-response, relapsers, partial responders). • Evaluate the effectiveness (SVR-12) of the combined treatment Sofosbuvir + pegylated interferon + ribavirin in relation to the stage of liver disease (defined as METAVIR fibrosis stage) and the presence or absence of cirrhosis. • Confirm the safety profile and tolerability of the combined treatment Sofosbuvir + pegylated interferon + ribavirin in patients with chronic hepatitis HCV genotype 1 who have failed at least six months a previous course of treatment with ribavirin and pegylated interferon and which do not show contraindications to the use of pegylated interferon and ribavirin. • Evaluate the proportion of interruption of the course of treatment due to adverse events;Primary end point(s): virological response at 12 weeks after the end of treatment (proportion of SVR-12, or negative viremia) of combination therapy pegylated interferon + ribavirin + Sofosbuvir;Timepoint(s) of evaluation of this end point: at 12 weeks after the end of treatment

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Secondary

Measure	Time frame
Secondary end point(s): 1.SVR-12 combined treatment of pegylated interferon + ribavirin + Sofosbuvir in relation to the viral response to the previous cycle of dual therapy (null-response, relapsers, partial responders) 2.SVR-12 combined treatment of pegylated interferon + ribavirin + Sofosbuvir in relation to the stage of liver disease (fibrosis / cirrhosis). 3.Adverse events and serious adverse events and tolerability of the combined treatment Sofosbuvir + pegylated interferon + ribavirin. 4Proportion of interruption of the course of treatment due to adverse events.;Timepoint(s) of evaluation of this end point: 1)at 12 weeks EOT 2)at 12 weeks EOT 3)EOT 4)EOT	—

Measure

Time frame

Secondary end point(s): 1.SVR-12 combined treatment of pegylated interferon + ribavirin + Sofosbuvir in relation to the viral response to the previous cycle of dual therapy (null-response, relapsers, partial responders) 2.SVR-12 combined treatment of pegylated interferon + ribavirin + Sofosbuvir in relation to the stage of liver disease (fibrosis / cirrhosis). 3.Adverse events and serious adverse events and tolerability of the combined treatment Sofosbuvir + pegylated interferon + ribavirin. 4Proportion of interruption of the course of treatment due to adverse events.;Timepoint(s) of evaluation of this end point: 1)at 12 weeks EOT 2)at 12 weeks EOT 3)EOT 4)EOT

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Countries

Italy

Contacts

Public ContactU.O. TERAPIA EPATITI CRONICHE VIRAL

Medicina Generale

alfredo.alberti@unipd.it0498212293

Outcome results

None listed

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