- 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…
ID
Bron
Verkorte titel
Aandoening
Chronic hepatitis C
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Immune response:<br>
o Baseline versus end-of-treatment versus follow-up<br>
o Patients with SVR versus patients with non-SVR<br>
o Patients with genotype 1 versus 3 versus 4
Doel van het onderzoek
- 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.
Onderzoeksopzet
Screening, day 0, week 1, 2, 4, 8, 12, 18 and 24 (if applicable) post-treatment week 4, 12, 24
Onderzoeksproduct en/of interventie
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
Publiek
Kamer: G4-214
Meike van der Ree
Amsterdam 1105
The Netherlands
020-5665383
meike.vanderree@amc.uva.nl
Wetenschappelijk
Kamer: G4-214
Meike van der Ree
Amsterdam 1105
The Netherlands
020-5665383
meike.vanderree@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5206 |
| NTR-old | NTR5353 |
| Ander register | METC/ dossiernummer : 2014_2497/AI444-281 |