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

Primary Purpose

PT-NANBH

Status

Withdrawn

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Simeprevir

Sofosbuvir

About this trial

This is an interventional treatment trial for PT-NANBH focused on measuring hepatitis C, liver transplantation, genotype 1

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

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

Exclusion criteria:

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

Sites / Locations

Stanford University Medical Center
Yale University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Simeprevir + sofosbuvir daily, 24 weeks

Arm Description

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.

Outcomes

Primary Outcome Measures

Sustained virologic response (SVR) HCV RNA PCR <25 IU/mL 12 weeks post-treatment

Secondary Outcome Measures

Serious adverse events, adverse events grade 3 and above

Full Information

NCT ID

NCT02485080

First Posted

June 23, 2015

Last Updated

October 12, 2016

Sponsor

Stanford University

Collaborators

Janssen Scientific Affairs, LLC, Yale University

1. Study Identification

Unique Protocol Identification Number

NCT02485080

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Withdrawn due to lack of resources

Study Start Date

September 2015 (undefined)

Primary Completion Date

January 2016 (Actual)

Study Completion Date

January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Stanford University

Collaborators

Janssen Scientific Affairs, LLC, Yale University

4. Oversight

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PT-NANBH

Keywords

hepatitis C, liver transplantation, genotype 1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simeprevir + sofosbuvir daily, 24 weeks

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Simeprevir

Other Intervention Name(s)

Olysio

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir

Other Intervention Name(s)

Sovaldi

Primary Outcome Measure Information:

Title

Sustained virologic response (SVR) HCV RNA PCR <25 IU/mL 12 weeks post-treatment

Time Frame

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 Measure Information:

Title

Serious adverse events, adverse events grade 3 and above

Time Frame

24 weeks while on treatment and 24 weeks after end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: 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 Exclusion criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mindie H Nguyen, MD, MAS

Organizational Affiliation

Stanford University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Stanford University Medical Center

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Yale University Medical Center

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

22212582

Citation

Roche B, Samuel D. Hepatitis C virus treatment pre- and post-liver transplantation. Liver Int. 2012 Feb;32 Suppl 1:120-8. doi: 10.1111/j.1478-3231.2011.02714.x.

Results Reference

background

PubMed Identifier

19217183

Citation

Carrion JA, Martinez-Bauer E, Crespo G, Ramirez S, Perez-del-Pulgar S, Garcia-Valdecasas JC, Navasa M, Forns X. Antiviral therapy increases the risk of bacterial infections in HCV-infected cirrhotic patients awaiting liver transplantation: A retrospective study. J Hepatol. 2009 Apr;50(4):719-28. doi: 10.1016/j.jhep.2008.11.015. Epub 2008 Dec 29.

Results Reference

background

PubMed Identifier

17125876

Citation

Iacobellis A, Siciliano M, Perri F, Annicchiarico BE, Leandro G, Caruso N, Accadia L, Bombardieri G, Andriulli A. Peginterferon alfa-2b and ribavirin in patients with hepatitis C virus and decompensated cirrhosis: a controlled study. J Hepatol. 2007 Feb;46(2):206-12. doi: 10.1016/j.jhep.2006.08.020. Epub 2006 Oct 20.

Results Reference

background

Links:

URL

http://www.hcvguidelines.org

Description

Recommendations for Testing, Managing, and Treating Hepatitis C by the American Association for the Study of Liver Diseases and Infectious Disease Society of America

URL

https://www.gilead.com/~/media/Files/pdfs/medicines/liver-disease/sovaldi/sovaldi_pi.pdf

Description

SOLVALDI (Sofosbuvir) package insert

Learn more about this trial

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

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