Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients
NCT ID: NCT02576314
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
PHASE3
48 participants
INTERVENTIONAL
2015-05-31
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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Sofosbuvir and Daclatasvir
Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.
sofosbuvir and daclatasvir
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once daily.
Ledipasvir/sofosbuvir
Participants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily for 12 weeks.
ledipasvir/sofosbuvir
Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally.
once daily;
Interventions
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sofosbuvir and daclatasvir
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once daily.
ledipasvir/sofosbuvir
Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally.
once daily;
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
* HCV RNA \> 10,000 IU/mL at Screening;
* Screening laboratory values within defined thresholds;
* Negative pregnancy test at baseline (females of childbearing potential only);
* Use of two effective contraception methods if female of childbearing potential or sexually active male.
Exclusion Criteria
* HIV infection or HBV infection (HBcAb and HBsAg positive);
* Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
* Active or recent history (≤ 1 year) of drug or alcohol abuse;
* 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 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 G3 Study
Identifier Type: -
Identifier Source: org_study_id
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