deLIVER: Direct Acting Antiviral Effects on the Liver (NCT02938013) | Clinical Trial Compass
CompletedPhase 4
deLIVER: Direct Acting Antiviral Effects on the Liver
United States15 participantsStarted 2017-01
Plain-language summary
Open-label, partially-randomized plasma and liver sampling study to assess hepatitis C virus (HCV) kinetics during treatment with two (Sofosbuvir/Velpatasvir) or three (Sofosbuvir/Velpatasvir/Voxilaprevir) direct acting antivirals (DAAs)
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Ability and willingness of participant to provide written informed consent.
✓. Men and women age ≥18 to ≤70 years at study entry
✓. Body mass index (BMI) ≥ 18 kg/m2
✓. HCV RNA ≥ 10,000 IU/mL at Screening
✓. HCV genotype 1a at Screening or within 6 months of screening
✓. Chronic HCV infection (≥ 6 months) documented by prior medical history
✓. HCV treatment-naïve with no prior treatment with any IFN, RBV, or approved or experimental HCV-specific DAA
✓. Absence of cirrhosis as defined as transient elastography (FibroScan®) liver stiffness measurement \< 12.5 kPa within 6 months of screening
Exclusion criteria
✕. Breastfeeding.
✕. Known allergy/sensitivity or any hypersensitivity to components of study drugs or their formulation.
✕. Acute or serious illness requiring systemic treatment and/or hospitalization within 42 days prior to study entry.
✕. Active hepatitis B infection (positive HBsAg) within 42 days prior to study entry.
✕. History of decompensated liver disease (including but not limited to encephalopathy, variceal bleeding, or ascites) prior to study entry.
What they're measuring
1
Total Number of HCV-infected Hepatocytes Measured in Liver Tissue Obtained by Liver Biopsy at Day 0 (Pre-treatment) and at Day 7 of Antiviral Therapy
✕. Any cause of liver disease other than chronic HCV infection, including but not limited to the following:
✕. Uncontrolled or active depression or other psychiatric disorder within 24 weeks prior to study entry that in the opinion of the investigator might preclude adherence to study requirements.
✕. Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.