SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients
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ClinicalTrials.gov Identifier: NCT02473211 |
Recruitment Status :
Completed
First Posted : June 16, 2015
Last Update Posted : March 19, 2018
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Condition or disease | Intervention/treatment | Phase |
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Chronic Hepatitis C Infection | Drug: Sofosbuvir Drug: Daclatasvir | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 106 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Efficacy and Safety of Sofosbuvir Plus Daclatasvir in Chinese Treatment-experienced Patients With Chronic Genotype 1b HCV Infection |
Study Start Date : | January 2015 |
Actual Primary Completion Date : | December 31, 2017 |
Actual Study Completion Date : | March 15, 2018 |
Arm | Intervention/treatment |
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Experimental: SOF+DCV
Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.
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Drug: Sofosbuvir
Sofosbuvir 400 mg tablet administered once daily
Other Name: GS-7977 Drug: Daclatasvir Daclatasvir 60mg tablet administered once daily
Other Name: BMS-790052 |
- Proportion of participants with sustained virologic response 12 weeks after the end of treatment (SVR12) [ Time Frame: Post treatment Week 12 ]SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) (15 IU/ml) 12 weeks following the last dose of study drug

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients chronically infected with HCV Genotype-1b;
- Documented evidence of relapse after completion of previous course of interferon-based regimen with or without ribavirin;
- HCV RNA level greater than 10,000 IU/ml at screening;
- Patients with compensated cirrhosis are permitted.
Exclusion Criteria:
- Current or prior history: Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded;
- Screening ECG with clinically significant abnormalities;
- Laboratory results outside of acceptable ranges at screening;
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02473211
China, Beijing | |
Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital | |
Beijing, Beijing, China, 100039 | |
China, Hong Kong | |
Humanity and Health GI and Liver Centre | |
Hong Kong, Hong Kong, China, 00852 |
Principal Investigator: | George KK Lau, MD | Humanity and Health GI and Liver Centre |
Responsible Party: | Humanity and Health Research Centre |
ClinicalTrials.gov Identifier: | NCT02473211 |
Other Study ID Numbers: |
H&H_SOF plus DCV treatment |
First Posted: | June 16, 2015 Key Record Dates |
Last Update Posted: | March 19, 2018 |
Last Verified: | March 2018 |
Infections Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Blood-Borne Infections Communicable Diseases |
Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Hepatitis, Chronic Sofosbuvir Antiviral Agents Anti-Infective Agents |