No registrations found.
ID
Source
Brief title
Health condition
Chronic hepatitis C
Sponsors and support
Intervention
Outcome measures
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
Study objective
- 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.
Study design
Screening, day 0, week 1, 2, 4, 8, 12, 18 and 24 (if applicable) post-treatment week 4, 12, 24
Intervention
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
Kamer: G4-214
Meike van der Ree
Amsterdam 1105
The Netherlands
020-5665383
meike.vanderree@amc.uva.nl
Kamer: G4-214
Meike van der Ree
Amsterdam 1105
The Netherlands
020-5665383
meike.vanderree@amc.uva.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5206 |
| NTR-old | NTR5353 |
| Other | METC/ dossiernummer : 2014_2497/AI444-281 |