| - candidate number | 22466 |
| - NTR Number | NTR5353 |
| - ISRCTN | ISRCTN no longer applicable |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 15-jul-2015 |
| - Secondary IDs | 2014_2497/AI444-281 METC/ dossiernummer |
| - Public Title | Immune phenotyping in chronic hepatitis C patients treated with Sofosbuvir and Daclatasvir combination with or without Ribavirin for 12 or 24 weeks -SODA study |
| - Scientific Title | Immune phenotyping in chronic hepatitis C patients treated with Sofosbuvir and Daclatasvir combination with or without Ribavirin for 12 or 24 weeks -SODA study |
| - ACRONYM | SODA |
| - hypothesis | - Restoration of HCV-specific T cell function by interferon-free therapy with Sofosbuvir + Daclatasvir ± Ribavirin - High sustained virological response rates (>90%) in HCV genotype 1, 3 and 4 patients after 12 or 24 weeks combination therapy with Daclatasvir, Sofosbuvir with and without RBV. - Good tolerability and safety of the combination DCV and SOF with or without RBV. |
| - Healt Condition(s) or Problem(s) studied | Hepatitis C, Chronic |
| - 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 - History or symptoms of decompensated liver disease: Child-Pugh Class B or C, including ascites, hepatic encephalopathy, esophageal variceal bleeding, or other signs of hepatic insufficiency or portal hypertension - History of hepatocellular carcinoma on imaging studies or serum alpha-fetoprotein (AFP) > 50 ng/mL at screening - Concurrent clinically significant medical diagnosis |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | no |
| - group | Parallel |
| - Type | 2 or more arms, non-randomized |
| - Studytype | intervention |
| - planned startdate | 1-okt-2014 |
| - planned closingdate | 1-okt-2016 |
| - Target number of participants | 32 |
| - Interventions | Genotype 1 and 4, fibrosis stage F0-F4 Daclatasvir + sofosbuvir 12 weeks Genotype 3, fibrosis stage F0-F3 Daclatasvir + sofosbuvir + ribavirin 12 weeks Genotype 3, fibrosis stage F4 Daclatasvir + sofosbuvir + ribavirin 24 weeks |
| - Primary outcome | Immune response: o Baseline versus end-of-treatment versus follow-up o Patients with SVR versus patients with non-SVR o Patients with genotype 1 versus 3 versus 4 |
| - Secondary outcome | - SVR12 in the study population - Proportion of patients with HCV RNA < LLOD at 4 and 24 weeks after cessation of therapy - Proportion of patients with HCV RNA < LLOD at week 4 during treatment - Any AE leading to discontinuation of the study drug |
| - Timepoints | Screening, day 0, week 1, 2, 4, 8, 12, 18 and 24 (if applicable) post-treatment week 4, 12, 24 |
| - Trial web site | |
| - status | open: patient inclusion |
| - CONTACT FOR PUBLIC QUERIES | Meike van der Ree |
| - CONTACT for SCIENTIFIC QUERIES | Meike van der Ree |
| - Sponsor/Initiator | Academic Medical Center (AMC), Amsterdam |
| - Funding (Source(s) of Monetary or Material Support) | Academic Medical Center (AMC), Amsterdam, BMS |
| - Publications | |
| - Brief summary | |
| - Main changes (audit trail) | |
| - RECORD | 15-jul-2015 - 25-aug-2015 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl