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SMV + SOF With/Without RBV for IFN-II Patients With CHC

Primary Purpose

Hepatitis C

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Simeprevir

Sofosbuvir

Ribavirin

About this trial

This is an interventional treatment trial for Hepatitis C

Eligibility Criteria

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

Inclusion Criteria:

Targeted at least 20% enrollment of patients with cirrhosis
Adults >/= age 18 years.
Active infection with hepatitis C virus (HCV) genotype 1
Must have health insurance that covers therapy with SOF+RBV
Female patients of childbearing age must have a negative pregnancy test prior to initiating therapy, use at least two effective methods of contraception during treatment, and undergo monthly pregnancy tests.
Patients must be either IFN-ineligible due to psychiatric, autoimmune, neurological, or other causes that are confirmed appropriate by the PI; OR,
IFN-intolerant due to flu-like symptoms, psychiatric problems, cytopenia or other causes deemed appropriate by the PI.

Exclusion Criteria:

Presence of HIV co-infection
Presence of hepatocellular carcinoma (HCC)
Prior organ transplantation
Any history of hepatic decompensation
Patients taking any of the following medications:
- Anticonvulsants- Carbamazepine, Oxcarbazepine, Phenobarbital, or Phenytoin.
- Anti-infectives-erythromycin, clarithromycin, or telithromycin.
- Antifungals- systemic itraconazole, ketoconazole, posaconazole, fluconazole, or voriconazole.
- Antimycobacterials- rifampin, rifabutin or rifapentine.
- Corticosteroids- systemic dexamethasone.
- Propulsives- Cisapride.
- Herbals- Milk thistle or St. John's Wart.
Patients that have been exposed to direct acting anti-viral agents
Patients with severe renal impairment (estimated Glomerular Filtration Rate (eGFR) <50 mL/min/1.73m2) or with end stage renal disease (ESRD).
Patients with platelet count <50 x109/L, Hemoglobin <10 g/dL, or Neutrophils <0.5 x109/L.
Women who are pregnant.
Men whose partners are pregnant or plan on becoming pregnant.

Sites / Locations

Scripps Clinic
Icahn School of Medicine at Mt. Sinai
Clinical Research Centers of America, LLC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

SMV+SOF

SMV+SOF+RBV

Arm Description

IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)

IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day

Outcomes

Primary Outcome Measures

Sustained Viral Response

Comparison of sustained virologic response at 12 weeks post-treatment (SVR12) in 2 arms of IFN-II patients: one receiving 12 weeks of simeprevir (SMV) (150mg QD)+ sofosbuvir (SOF) (400mg QD) and the second receiving to SMV (150mg QD)+SOF (400mg QD)+weight-based ribavirin (RBV) 1000-1200 mg/day. SVR12 is defined as a patient having undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) levels 12 weeks post-treatment. Achieving SVR12 is generally indicative of hepatitis C infection being cured.

Secondary Outcome Measures

Full Information

NCT ID

NCT02214420

First Posted

August 8, 2014

Last Updated

May 21, 2018

Sponsor

SC Liver Research Consortium, LLC

Collaborators

Janssen, LP

1. Study Identification

Unique Protocol Identification Number

NCT02214420

Brief Title

SMV + SOF With/Without RBV for IFN-II Patients With CHC

Official Title

Simeprevir (SMV) + Sofosbuvir (SOF) With or Without Ribavirin (RBV) for Interferon-intolerant or Ineligible (IFN-II) Patients With Chronic Hepatitis C (CHC)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

SC Liver Research Consortium, LLC

Collaborators

Janssen, LP

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Prior trials have shown that many G1 CHC patients are ineligible or intolerant to pegylated (PEG)-based regimens due to prior severe side effects, worsening of cytopenias, exacerbation of underlying psychiatric disorders, or autoimmune disorders. These patients will not be candidates for treatment with the approvals of SMV and SOF in early 2014 due to the combination with PEG-regimens. Results of the COSMOS study suggest that these patients are likely to have excellent responses to SMV+SOF with or without RBV with 12 weeks of therapy, and that 24 weeks are unnecessary. This trial is designed to rapidly enroll and be completed in order to confirm this hypothesis.

6. Conditions and Keywords

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

Hepatitis C

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SMV+SOF

Arm Type

Active Comparator

Arm Description

IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD)

Arm Title

SMV+SOF+RBV

Arm Type

Active Comparator

Arm Description

IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day

Intervention Type

Drug

Intervention Name(s)

Simeprevir

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir

Intervention Type

Drug

Intervention Name(s)

Ribavirin

Primary Outcome Measure Information:

Title

Sustained Viral Response

Description

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Targeted at least 20% enrollment of patients with cirrhosis Adults >/= age 18 years. Active infection with hepatitis C virus (HCV) genotype 1 Must have health insurance that covers therapy with SOF+RBV Female patients of childbearing age must have a negative pregnancy test prior to initiating therapy, use at least two effective methods of contraception during treatment, and undergo monthly pregnancy tests. Patients must be either IFN-ineligible due to psychiatric, autoimmune, neurological, or other causes that are confirmed appropriate by the PI; OR, IFN-intolerant due to flu-like symptoms, psychiatric problems, cytopenia or other causes deemed appropriate by the PI. Exclusion Criteria: Presence of HIV co-infection Presence of hepatocellular carcinoma (HCC) Prior organ transplantation Any history of hepatic decompensation Patients taking any of the following medications: Anticonvulsants- Carbamazepine, Oxcarbazepine, Phenobarbital, or Phenytoin. Anti-infectives-erythromycin, clarithromycin, or telithromycin. Antifungals- systemic itraconazole, ketoconazole, posaconazole, fluconazole, or voriconazole. Antimycobacterials- rifampin, rifabutin or rifapentine. Corticosteroids- systemic dexamethasone. Propulsives- Cisapride. Herbals- Milk thistle or St. John's Wart. Patients that have been exposed to direct acting anti-viral agents Patients with severe renal impairment (estimated Glomerular Filtration Rate (eGFR) <50 mL/min/1.73m2) or with end stage renal disease (ESRD). Patients with platelet count <50 x109/L, Hemoglobin <10 g/dL, or Neutrophils <0.5 x109/L. Women who are pregnant. Men whose partners are pregnant or plan on becoming pregnant.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Pockros, MD

Organizational Affiliation

Scripps Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Scripps Clinic

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

Icahn School of Medicine at Mt. Sinai

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Clinical Research Centers of America, LLC

City

Murray

State/Province

Utah

ZIP/Postal Code

84123

Country

United States

12. IPD Sharing Statement

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SMV + SOF With/Without RBV for IFN-II Patients With CHC

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