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

NCT02214420 | Completed Phase 4 Results

• 1 other identifier: PJPIIS-01-14
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Study Arms (2)

SMV+SOF

ACTIVE COMPARATOR

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

Drug: Simeprevir; Drug: Sofosbuvir

SMV+SOF+RBV

ACTIVE COMPARATOR

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

Drug: Simeprevir; Drug: Sofosbuvir; Drug: Ribavirin

Interventions

Simeprevir DRUG

SMV+SOF; SMV+SOF+RBV

Sofosbuvir DRUG

SMV+SOF; SMV+SOF+RBV

Ribavirin DRUG

SMV+SOF+RBV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• SC Liver Research Consortium, LLC: lead
• Janssen, LP: collaborator

Study Sites (3)

Scripps Clinic

La Jolla, California, 92037, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

Clinical Research Centers of America, LLC

Murray, Utah, 84123, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Simeprevir; Sofosbuvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides

Results Point of Contact

• Title: Dr. Paul Pockros
• Organization: Scripps Clinic

Pockros.paul@scrippshealth.org

(858) 554-8879

Study Officials

• Paul Pockros, MD

  Scripps Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2014
• First Posted: August 12, 2014
• Study Start: October 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 19, 2018
• Results First Posted: May 17, 2018

Record last verified: 2018-05

Locations

US (3)