Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination and Sofosbuvir + Ribavirin for Subjects With Chronic Hepatitis C Virus (HCV) and Inherited Bleeding Disorders
NCT ID: NCT02120300
Last Updated: 2016-12-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
122 participants
INTERVENTIONAL
2014-04-30
2015-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LDV/SOF GT 1 or 4
Participants with chronic genotypes (GT) 1 or 4 HCV infection will receive LDV/SOF for 12 or 24 weeks. Treatment-experienced cirrhotic participants with genotype 1 HCV infection will receive LDV/SOF for 24 weeks.
LDV/SOF
90/400 mg FDC tablet administered orally
SOF+RBV 12 wks GT 2
Participants with chronic genotype 2 HCV infection will receive SOF+RBV for 12 weeks.
SOF
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)
SOF+RBV 24 wks GT 3
Participants with chronic genotype 3 HCV infection will receive SOF+RBV for 24 weeks.
SOF
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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LDV/SOF
90/400 mg FDC tablet administered orally
SOF
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
* Chronic genotype 1, 2, 3 or 4 HCV infection
* HCV RNA ≥ 1000 IU/mL at screening
* Use of protocol specified method(s) of contraception if female of childbearing potential or sexually active male
* Screening laboratory values within defined thresholds
* For HIV-1/HCV co-infected individuals:
* Suppressed HIV-1 RNA on an antiretroviral (ARV) regimen for at least 6 months prior to screening
* Stable protocol-approved ARV regimen for \> 8 weeks prior to screening
* CD4 T-cell count \> 200 cells/mm\^3 at screening
Exclusion Criteria
* Current or prior history of any of the following:
* Hepatic decompensation
* Chronic liver disease of a non-HCV etiology
* Hepatocellular carcinoma (HCC)
* Infection with hepatitis B virus (HBV)
* Pregnant or nursing female
* Prior treatment with inhibitors of nonstructural protein 5A (NS5A) or the NS5B polymerase
* Chronic use of systemically administered immunosuppressive agents
* For HIV-1/HCV co-infected individuals:
* Opportunistic infection within 6 months prior to screening
* Active, serious infection (other than HIV-1 or HCV) requiring parental antibiotics, antivirals or antifungals within 30 days prior to baseline
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Robert H Hyland, DPhil
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
Washington D.C., District of Columbia, United States
Atlanta, Georgia, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Newark, New Jersey, United States
New York, New York, United States
Rochester, New York, United States
Chapel Hill, North Carolina, United States
Philadelphia, Pennsylvania, United States
Countries
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References
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Walsh C, Workowski K, Terrault N, Sax S, Cohen A, et al. Approved All-Oral Sofosbuvir Regimens Are Safe and Highly Effective in Patients With Hereditary Bleeding Disorders. (2015). Hepatology, 62 (S1): 714A-807A. doi:10.1002/hep.28228
Other Identifiers
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GS-US-334-1274
Identifier Type: -
Identifier Source: org_study_id