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

Phase 4

Withdrawn

• Conditions: PT-NANBH
• Interventions: Drug: Simeprevir; Drug: Sofosbuvir

• Registration Number: NCT02485080
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Key objectives of this study include:

1. To describe efficacy (SVR) in a special population of patients with chronic hepatitis C who are not willing or not candidates for IFN-based therapy.

2. To describe safety, tolerability, and treatment persistency in this patient population with advanced liver disease.

Study Timeline

• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-25
• Study First Posted: 2015-06-30
• Study Start: 2015-09
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Simeprevir + sofosbuvir daily, 24 weeks	Sofosbuvir	Eligible and consenting patients will be treated with sofosbuvir (SOF) 400 mg daily and simeprevir (SMV) 150 mg daily for 24 weeks. Both drugs will be administered orally, per manufacturers' instructions.
Simeprevir + sofosbuvir daily, 24 weeks	Simeprevir	Eligible and consenting patients will be treated with sofosbuvir (SOF) 400 mg daily and simeprevir (SMV) 150 mg daily for 24 weeks. Both drugs will be administered orally, per manufacturers' instructions.

Primary Outcome Measures

Name	Time	Method
Sustained virologic response (SVR) HCV RNA PCR <25 IU/mL 12 weeks post-treatment	12 weeks after end of treatment or virologic response after liver transplantation, whichever comes first, assessed up to 12 weeks after end of treatment

Secondary Outcome Measures

Name	Time	Method
Serious adverse events, adverse events grade 3 and above	24 weeks while on treatment and 24 weeks after end of treatment

Trial Locations

Locations (2)

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

Yale University Medical Center; 🇺🇸 New Haven, Connecticut, United States