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Immune phenotyping in chronic hepatitis C patients treated with Sofosbuvir and Daclatasvir combination with or without Ribavirin for 12 or 24 weeks -SODA study


- candidate number22466
- NTR NumberNTR5353
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-jul-2015
- Secondary IDs2014_2497/AI444-281 METC/ dossiernummer
- Public TitleImmune phenotyping in chronic hepatitis C patients treated with Sofosbuvir and Daclatasvir combination with or without Ribavirin for 12 or 24 weeks -SODA study
- Scientific TitleImmune phenotyping in chronic hepatitis C patients treated with Sofosbuvir and Daclatasvir combination with or without Ribavirin for 12 or 24 weeks -SODA study
- ACRONYMSODA
- 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) studiedHepatitis C, Chronic
- Inclusion criteria- Subjects infected with HCV genotype 1, 3 or 4.
- Subjects who are treatment-na´ve 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 receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-okt-2014
- planned closingdate1-okt-2016
- Target number of participants32
- InterventionsGenotype 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 outcomeImmune 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
- TimepointsScreening, day 0, week 1, 2, 4, 8, 12, 18 and 24 (if applicable) post-treatment week 4, 12, 24
- Trial web site
- statusopen: 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), BMS
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD15-jul-2015 - 25-aug-2015


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