A study looking at the immune response in chronic hepatitis C patients treated with Sofosbuvir and Daclatasvir combination with or without Ribavirin for 12 or 24 weeks.
- Conditions
- Chronic hepatitis CTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2014-002808-25-NL
- Lead Sponsor
- Academic Medical Center Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 IFN-alpha based therapies (including first generation PI failures). 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:
oPlatelets >50x109/L
oTotal white blood cells >3.0x109/L and absolute neutrophil count >1.5x109/L
oHemoglobin >6.8 mmol/L for females and >7.4 mmol/L for males
oTotal and direct bilirubin < 2 x ULN
oALT < 10 x ULN
oSerum 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 32
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
-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 clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method