Immune phenotyping in chronic HCV patients treated with Sofosbuvir and Daclatasvir combination for 12 or 24 weeks * SODA study
- Conditions
- Chronic hepatitis C1001965410047438Hepatitis C
- Registration Number
- NL-OMON44573
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 32
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 < 2 x ULN
o ALT < 10 x ULN
o Serum creatinine within normal limits and estimated creatinine clearance rate as calculated by the Cockcroft-Gault formula >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.
- 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>- Immune response in patients<br /><br>o Baseline versus end-of-treatment versus follow-up<br /><br>o Patients with SVR versus patients with non-SVR<br /><br>o Patients with genotype 1 versus 3 versus 4</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. Proportion of patients with SVR12 in the study population<br /><br>2. Proportion of patients with HCV RNA < LLOD at 4 and 24 weeks after cessation<br /><br>of therapy.<br /><br>3. Proportion of patients with HCV RNA < LLOD at week 4 during treatment.<br /><br>4. Any AE leading to discontinuation of the study drug. </p><br>