Ledipasvir/Sofosbuvir Fixed-Dose Combination + Ribavirin in Subjects With Chronic HCV With Advanced Liver Disease or Post-Liver Transplant
NCT ID: NCT01938430
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
339 participants
INTERVENTIONAL
2013-09-30
2015-03-31
Brief Summary
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* Cohort A: decompensated cirrhosis (advanced liver disease), no prior liver transplant;
* Cohort B: post-liver transplant, with or without cirrhosis;
* Group assignment within cohorts is based on severity of liver impairment at screening (Child-Pugh-Turcotte (CPT) score for participants with cirrhosis; fibrosis; or presence of disease for fibrosing cholestatic hepatitis (FCH) groups)
* Randomization is 1:1 within groups to 12 or 24 weeks of LDV/SOF+RBV treatment.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort A, Group 1 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Cohort A, Group 1 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Cohort A, Group 2 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Cohort A, Group 2 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Cohort B, Group 3 (12 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) plus RBV (weight-based: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Cohort B, Group 3 (24 wk): F0-F3 Fibrosis
LDV/SOF (90/400 mg) plus RBV (weight-based: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Cohort B, Group 4 (12 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) plus RBV (weight-based: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Cohort B, Group 4 (24 wk): CPT Class A (5-6)
LDV/SOF (90/400 mg) plus RBV (weight-based: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Cohort B, Group 5 (12 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Cohort B, Group 5 (24 wk): CPT Class B (7-9)
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Cohort B, Group 6 (12 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Cohort B, Group 6 (24 wk): CPT Class C (10-12)
LDV/SOF (90/400 mg) plus RBV (starting at 600 mg, then adjusted ± based on tolerability \[weight-based maximum: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg\]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Cohort B, Group 7 (12 wk): FCH
LDV/SOF (90/400 mg) plus RBV (weight-based: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Cohort B, Group 7 (24 wk): FCH
LDV/SOF (90/400 mg) plus RBV (weight-based: \< 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Interventions
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LDV/SOF
LDV/SOF FDC tablet administered orally once daily
RBV
RBV tablets administered orally in a divided daily dose
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Chronic genotype 1 or 4 HCV infection
* Normal ECG
* Negative serum pregnancy test for female subjects
* Male subjects and female subjects of childbearing potential must agree to use contraception
* Able to comply with the dosing instructions for study drug and able to complete the study schedule of assessments, including all required post treatment visits
Exclusion Criteria
* HIV or hepatitis B viral (HBV) infection
* Stomach disorder that could interfere with the absorption of the study drug
* Treated with an anti-HCV medication in the last 30 days
* Any prior exposure to an HCV nonstructural protein (NS)5a-specific inhibitor
* Use of human granulocyte-macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other therapeutic hematopoietic agents within 2 weeks of screening
* History of clinically significant medical condition associated with other chronic liver disease
* Active spontaneous bacterial peritonitis at screening
* Females who are breastfeeding
* Infection requiring systemic antibiotics
* Participated in a clinical study with an investigational drug or biologic within the last 30 days
* Active or history (last 6 months) of drug or alcohol abuse
* History of organ transplant other than liver or kidney
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Shampa De-Oertel, PhD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Phoenix, Arizona, United States
San Diego, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Kansas City, Kansas, United States
Lutherville, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Detroit, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
New York, New York, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Dallas, Texas, United States
Murray, Utah, United States
Richmond, Virginia, United States
Seattle, Washington, United States
Seattle, Washington, United States
Countries
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References
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Welzel TM, Reddy KR, Flamm SL, Denning J, Lin M, Hyland R, Pang PS, McHutchison JG, Charlton M, Everson GT, Zeuzem S, Afdhal N. On-treatment HCV RNA in patients with varying degrees of fibrosis and cirrhosis in the SOLAR-1 trial. Antivir Ther. 2016;21(6):541-546. doi: 10.3851/IMP3037. Epub 2016 Feb 18.
Charlton M, Everson GT, Flamm SL, Kumar P, Landis C, Brown RS Jr, Fried MW, Terrault NA, O'Leary JG, Vargas HE, Kuo A, Schiff E, Sulkowski MS, Gilroy R, Watt KD, Brown K, Kwo P, Pungpapong S, Korenblat KM, Muir AJ, Teperman L, Fontana RJ, Denning J, Arterburn S, Dvory-Sobol H, Brandt-Sarif T, Pang PS, McHutchison JG, Reddy KR, Afdhal N; SOLAR-1 Investigators. Ledipasvir and Sofosbuvir Plus Ribavirin for Treatment of HCV Infection in Patients With Advanced Liver Disease. Gastroenterology. 2015 Sep;149(3):649-59. doi: 10.1053/j.gastro.2015.05.010. Epub 2015 May 15.
Other Identifiers
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GS-US-337-0123
Identifier Type: -
Identifier Source: org_study_id
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