Overview

Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1

Status:
Withdrawn

Trial end date:
2016-01-01

Target enrollment:
0

Participant gender:
All

Summary

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Stanford University

Collaborators:

Janssen Scientific Affairs, LLC
Yale University

Treatments:

Simeprevir
Sofosbuvir

Criteria

Inclusion criteria:

1. Adult 18-72 years

2. 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.

3. HCV genotype 1 or indeterminate and later assessed at Screening and confirmed as
genotype 1

Exclusion criteria:

1. Uncontrolled ascites, uncontrolled hepatic encephalopathy, or uncontrolled
esophageal/gastric varices

2. Co-infection with HIV or hepatitis B (HBV)

3. CPT 7 or above, or MELD >10

4. Total bilirubin 4.0 mg/dL or above

5. CrCl (creatinine clearance) < 30 mL/min

6. Any unstable active medical illnesses.

7. Active use of illicit substances, alcohol, or smoking.

8. 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

9. 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

10. Platelet < 30 K/uL