Status:
COMPLETED
SMV + SOF With/Without RBV for IFN-II Patients With CHC
Lead Sponsor:
SC Liver Research Consortium, LLC
Collaborating Sponsors:
Janssen, LP
Conditions:
Hepatitis C
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT02214420
Start Date
October 1 2014
End Date
June 1 2016
Last Update
June 19 2018
Active Locations (3)
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1
Scripps Clinic
La Jolla, California, United States, 92037
2
Icahn School of Medicine at Mt. Sinai
New York, New York, United States, 10029
3
Clinical Research Centers of America, LLC
Murray, Utah, United States, 84123