Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1
Withdrawn before enrolling · Phase 4
Conditions studied: PT-NANBH
In brief
The goal of this pilot study is to examine both efficacy and tolerability in patients with HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver transplantation. A higher CPT score denotes higher necessity of liver transplantation.
Key facts
- Study ID
- NCT02485080
- Run by
- Stanford University
- People needed
- 0
- Starts
- 2015-09-01
- Expected to finish
- 2016-01-01
- Last updated by the study team
- 2016-10-13
Who can join
Age: 18 and older, up to 72. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adult 18-72 years
- Cirrhosis: defined by stage 4 on biopsy or noninvasive tests or presence of splenomegaly and platelet of 130K or lower, or presence of shrunken nodular liver on CT or MRI, or presence of varices or encephalopathy or ascites.
- HCV genotype 1 or indeterminate and later assessed at Screening and confirmed as genotype 1
You may not qualify if…
- Uncontrolled ascites, uncontrolled hepatic encephalopathy, or uncontrolled esophageal/gastric varices
- Co-infection with HIV or hepatitis B (HBV)
- CPT 7 or above, or MELD >10
- Total bilirubin 4.0 mg/dL or above
- CrCl (creatinine clearance) < 30 mL/min
- Any unstable active medical illnesses.
- Active use of illicit substances, alcohol, or smoking.
- Any malignancy within last 5 years except for basal cell skin cancer that has been adequately treated or HCC within Milan or UCSF criteria, which will be acceptable
- Any prior treatment with direct acting antivirals (approved or investigational), including HCV protease inhibitors, such as SMV. Patients who received prior treatment with SOF, and/or NS5A inhibitors (e.g. ledipasvir or Daclatasvir) can be included in this study
- Platelet < 30 K/uL
Where it is running
- Stanford University Medical Center — Palo Alto, California, United States
- Yale University Medical Center — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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