Chronic hepatitis C Hepatitis C
Conditions
Interventions
Sofosbuvir 400 mg daily + daclatasvir 60 mg daily ± RBV (1000 or 1200 mg / day)
for 12 or 24 weeks
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent - Willingness to sign the written ICF. 2. Target population - Previous documentation of positive HCV serology (HCV antibody or HCV RNA) at least 24 weeks prior to enrollment to study, OR Positive HCV serology (HCV antibody or HCV RNA) with a prior remote risk factor (more than 24 weeks prior to Screening) for the acquisition of hepatitis C. - Subjects infected with HCV genotype 1, 3 or 4 on screening laboratory test OR previous availaible documentation of HCV genotype 1,3 or 4 genotype. - Treatment-naïve to or relapsed after any previous antiviral therapy other than combination of sofosbuvir + NS5A inhibitor ± ribavirin. Relapse is defined as the recurrence of HCV RNA following the termination of a full course of treatment and after having achieved an undetectable HCV RNA during treatment. 3. Age and reproductive status - Age: 18 - 65 years - Subjects must agree to use birth control (condoms) from the time of dosing until 90 days after the follow-up visit; male or female patients who are surgically sterile need not to employ a method of contraception 4. Laboratory test findings - Screening hematology, clinical chemistries, coagulation and urinalysis are not clinically significant and the following criteria are met: o Platelets >50x10^9/L o Total white blood cells >3.0x10^9/L and absolute neutrophil count >1.5x10^9/L o Hemoglobin >6.8 mmol/L for females and >7.4 mmol/L for males o Total and direct bilirubin 50 mL/min - Negative results on the following screening laboratory tests: HBsAg and HIV antibody OR previous availaible documentation within 1 year before screening of HBsAg and HIV antibody negativity.
Exclusion criteria
Exclusion criteria: - 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 - Concurrent clinically significant medical diagnosis (other than hepatitis C-related conditions) that would potentially interfere with the subjects study compliance or confound study results - History of relevant drug and/or food allergies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: - Immune response in patients 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
| Measure | Time frame |
|---|---|
| 1. Proportion of patients with SVR12 in the study population 2. Proportion of patients with HCV RNA | — |
Countries
Netherlands
Outcome results
None listed