Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients
NCT ID: NCT02482077
Last Updated: 2018-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
112 participants
INTERVENTIONAL
2015-01-31
2018-03-15
Brief Summary
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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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SOF+RBV 8 wk
Participants will receive SOF+RBV for 8 weeks.
SOF+RBV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
SOF+RBV 12 wk
Participants will receive SOF+RBV for 12 weeks.
SOF+RBV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
SOF+DCV 8 wk
Participants will receive SOF+DCV for 8 weeks.
SOF+DCV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.
SOF+DCV 12 wk
Participants will receive SOF+DCV for 12 weeks.
SOF+DCV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.
LDV/SOF 8 wk
Participants will receive LDV/SOF for 8 weeks.
LDV/SOF
Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
LDV/SOF 12 wk
Participants will receive LDV/SOF for 12 weeks.
LDV/SOF
Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
Interventions
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SOF+RBV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
SOF+DCV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.
LDV/SOF
Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
3. HCV RNA \> 10,000 IU/mL at Screening;
4. Screening laboratory values within defined thresholds
5. Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria
2. HIV or chronic hepatitis B virus (HBV) infection;
3. Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
4. Active or recent history (≤ 1 year) of drug or alcohol abuse;
5. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).
18 Years
ALL
No
Sponsors
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Beijing 302 Hospital
OTHER
Humanity and Health Research Centre
OTHER
Responsible Party
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Principal Investigators
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George KK Lau, MD
Role: PRINCIPAL_INVESTIGATOR
Humanity and Health GI and Liver Centre
Locations
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Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
Beijing, Beijing Municipality, China
Humanity and Health GI and Liver Centre
Hong Kong, Hong Kong, China
Countries
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Other Identifiers
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H&H_HCV G2 Study
Identifier Type: -
Identifier Source: org_study_id
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