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| Name | Class |
|---|---|
| Janssen, LP | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SMV+SOF | Active Comparator | IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simeprevir | Drug |
| ||
| Sofosbuvir |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Paul Pockros, MD | Scripps Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Scripps Clinic | La Jolla | California | 92037 | United States | ||
| Icahn School of Medicine at Mt. Sinai |
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| ID | Title | Description |
|---|---|---|
| FG000 | SMV+SOF | Interferon (IFN)-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) Simeprevir Sofosbuvir |
| FG001 | SMV+SOF+RBV | Interferon (IFN)-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day Simeprevir Sofosbuvir Ribavirin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SMV+SOF | IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) Simeprevir Sofosbuvir |
| BG001 | SMV+SOF+RBV | IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day Simeprevir Sofosbuvir Ribavirin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 12 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SMV+SOF | IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) Simeprevir Sofosbuvir |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea or other GI discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Paul Pockros | Scripps Clinic | (858) 554-8879 | Pockros.paul@scrippshealth.org |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D000069616 | Simeprevir |
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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|
| Ribavirin | Drug |
|
| New York |
| New York |
| 10029 |
| United States |
| Clinical Research Centers of America, LLC | Murray | Utah | 84123 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Full Range | kg/m^2 |
|
IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day Simeprevir Sofosbuvir Ribavirin |
|
|
| 0 |
| 14 |
| 13 |
| 14 |
| EG001 | SMV+SOF+RBV | IFN-II patients will receive 12 weeks of OLYSIO (Simeprevir) (150mg QD) + SOVALDI (Sofosbuvir) (400mg QD) + weight-based Ribavirin 1000-1200 mg/day Simeprevir Sofosbuvir Ribavirin | 0 | 10 | 9 | 10 |
| Fatigue | Nervous system disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Cough and cold symptoms | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Photosensitivity | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dizziness | Ear and labyrinth disorders | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pruritis or rash | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006575 |
| Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |