- candidate number | 22466 |
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- NTR Number | NTR5353 |
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- ISRCTN | ISRCTN no longer applicable |
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- Date ISRCTN created | |
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- date ISRCTN requested | |
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- Date Registered NTR | 15-jul-2015 |
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- Secondary IDs | 2014_2497/AI444-281 METC/ dossiernummer |
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- 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 |
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- 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 |
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- ACRONYM | SODA |
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- 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. |
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- Healt Condition(s) or Problem(s) studied | Hepatitis C, Chronic |
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- 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 |
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- 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 |
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- mec approval received | yes |
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- multicenter trial | yes |
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- randomised | no |
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- group | Parallel |
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- Type | 2 or more arms, non-randomized |
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- Studytype | intervention |
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- planned startdate | 1-okt-2014 |
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- planned closingdate | 1-okt-2016 |
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- Target number of participants | 32 |
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- 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 |
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- 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 |
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- 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 |
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- Timepoints | Screening, day 0, week 1, 2, 4, 8, 12, 18 and 24 (if applicable) post-treatment week 4, 12, 24
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- Trial web site | |
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- status | open: patient inclusion |
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- CONTACT FOR PUBLIC QUERIES | Meike van der Ree |
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- CONTACT for SCIENTIFIC QUERIES | Meike van der Ree |
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- Sponsor/Initiator | Academic Medical Center (AMC), Amsterdam |
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- Funding
(Source(s) of Monetary or Material Support) | Academic Medical Center (AMC), Amsterdam, BMS |
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- Publications | |
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- Brief summary | |
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- Main changes (audit trail) | |
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- RECORD | 15-jul-2015 - 25-aug-2015 |