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

Safety, Tolerability, and Efficacy of Simeprevir 150 mg Daily Plus Sofosbuvir 400 mg Daily for 24 Weeks in Patients With Chronic Hepatitis C Genotype 1 With CPT Score of 6 or Lower Who Are IFN-Intolerant or Unwilling to be Treated With IFN

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02485080

Enrollment

Registered

2015-06-30

Start date

2015-09-30

Completion date

2016-01-31

Last updated

2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PT-NANBH

Keywords

hepatitis C, liver transplantation, genotype 1

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.

Interventions

DRUGSimeprevir

DRUGSofosbuvir

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 72 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026