Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis
NCT ID: NCT02128542
Last Updated: 2016-08-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
66 participants
INTERVENTIONAL
2014-06-30
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Sofosbuvir+RBV 12 weeks
Participants will receive sofosbuvir+RBV for 12 weeks.
Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Interventions
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Sofosbuvir
Sofosbuvir 400 mg tablet administered orally once daily
RBV
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Treatment-naive or treatment-experienced adult, U.S. Veteran
* Chronic genotype 2 (GT2) HCV infection Classified as:
* Eligible for treatment with interferon (IFN)-based therapy
* Ineligible for IFN treatment
* Intolerant to IFN.
* Cirrhosis determination
* Laboratory parameters within prespecified ranges at screening:
* A negative serum pregnancy test is required for females of childbearing potential
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Lactating females must agree to discontinue nursing before study drug is administered.
* Males must agree to refrain from sperm donation from the date of screening until at least 7 months after the last dose of RBV, or 90 days after their last dose of study drug if not taking RBV.
* Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
* Must be of generally good health as determined by the Investigator.
Exclusion Criteria
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
* History of any other clinically significant chronic liver disease (e.g., hemochromatosis; Wilson's disease; α1-antitrypsin deficiency), except nonalcoholic steatohepatitis (NASH).
* Decompensated liver
* History of hemoglobinopathies
* Contraindication or hypersensitivity to RBV
* History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participation for the full duration of the study, such that it is not in the best interest of the individual to participate.
* Clinically significant ECG abnormality at screening.
* History of solid organ transplantation.
* Presence of hepatocellular carcinoma (HCC) Malignancy within 5 years prior to screening, with the exception of specific cancers that are entirely cured by surgical resection (basal cell skin cancer and prostate cancer in remission). Individuals under evaluation for possible malignancy are not eligible.
* Prior treatment with an NS5B polymerase inhibitor.
* Chronic use of systemic immunosuppressive agents or immunomodulatory agents (e.g., prednisone equivalent \> 10 mg/day).
* Concomitant disallowed as per the Sovaldi Packet Insert.
* Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
* History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
* Use of any prohibited concomitant medications as described in the study protocol
* Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
* Male with pregnant female partner.
* In the judgment of the investigator any clinically-relevant drug or alcohol abuse within 12 months of screening that may interfere with treatment, assessment or compliance with the protocol.
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Lorenzo Rossaro, MD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Long Beach, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
San Diego, California, United States
San Francisco, California, United States
New Haven, Connecticut, United States
Miami, Florida, United States
Decatur, Georgia, United States
Baltimore, Maryland, United States
Kansas City, Missouri, United States
Durham, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Richmond, Virginia, United States
Countries
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References
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Ho SB, Monto A, Peyton A, Kaplan DE, Byrne S, Moon S, Copans A, Rossaro L, Roy A, Le H, Dvory-Sobol H, Zhu Y, Brainard DM, Guyer W, Shaikh O, Fuchs M, Morgan TR; VALOR study team. Efficacy of Sofosbuvir Plus Ribavirin in Veterans With Hepatitis C Virus Genotype 2 Infection, Compensated Cirrhosis, and Multiple Comorbidities. Clin Gastroenterol Hepatol. 2017 Feb;15(2):282-288. doi: 10.1016/j.cgh.2016.05.024. Epub 2016 May 27.
Other Identifiers
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GS-US-334-1379
Identifier Type: -
Identifier Source: org_study_id
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