Immune phenotyping in chronic hepatitis C patients treated with Sofosbuvir and Daclatasvir combination with or without Ribavirin for 12 or 24 weeks -SODA study
Recruiting
- Conditions
- Chronic hepatitis C
- Registration Number
- NL-OMON27532
- Lead Sponsor
- AMC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 32
Inclusion Criteria
Subjects infected with HCV genotype 1, 3 or 4.
- Subjects who are treatment-naïve to or relapsed after any previous antiviral therapy other than combination of sofosbuvir + NS5A inhibitor ± ribavirin
- Age: 18 - 65 years
- Males, or post-menopausal or hysterectomized females
Exclusion Criteria
- Women of childbearing potential
- Other known cause of liver disease except for CHC
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Immune response:<br /><br>o Baseline versus end-of-treatment versus follow-up<br /><br>o Patients with SVR versus patients with non-SVR<br /><br>o Patients with genotype 1 versus 3 versus 4
- Secondary Outcome Measures
Name Time Method - SVR12 in the study population<br /><br>- Proportion of patients with HCV RNA < LLOD at 4 and 24 weeks after cessation of therapy<br /><br>- Proportion of patients with HCV RNA < LLOD at week 4 during treatment<br /><br>- Any AE leading to discontinuation of the study drug