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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
Sponsor:
Collaborator:
Beijing 302 Hospital
Information provided by (Responsible Party):
Humanity and Health Research Centre

Study Description
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Brief Summary:
For those chronic hepatitis C patients, who are interferon-ineligible or intolerant, there is a burning need for the development of pan-oral interferon-free regimen. The investigators examine the efficacy and safety of sofosbuvir, a NS5B nucleotide polymerase inhibitor and daclatasvir, an NS5A replication complex inhibitor in Chinese treatment-experienced cirrhosis patients with chronic G1b infection.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: Sofosbuvir Drug: Daclatasvir Phase 2 Phase 3

Detailed Description:
Chinese genotype 1b HCV treatment-experienced cirrhotic patients are recruited and treated with 12 weeks sofosbuvir 400 mg daily plus daclatasvir 60 mg daily. At baseline, liver stiffness measurement (LSM) using transient elastography (FibroScan®) is used to assess liver fibrosis and the single nucleotide polymorphism ofinterferon-λ 3 (IL-28, rs12979860, C or T) and IFLN4 (ss469415590, TT or ΔG) is determined. Serial measurement of plasma HCV RNA levels are performed with the use of the COBAS TaqMan real-time assay (Roche version 2.0), at baseline, Day 2,4 and 7, week 2,4 and 12, post-treatment week 12. The primary efficacy end point is a sustained virologic response 12 weeks after the end of treatment (SVR12).
Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C

Arms and Interventions
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Arm Intervention/treatment
Experimental: SOF+DCV
Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients chronically infected with HCV Genotype-1b;
  2. Documented evidence of relapse after completion of previous course of interferon-based regimen with or without ribavirin;
  3. HCV RNA level greater than 10,000 IU/ml at screening;
  4. Patients with compensated cirrhosis are permitted.

Exclusion Criteria:

  1. 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;
  2. Screening ECG with clinically significant abnormalities;
  3. Laboratory results outside of acceptable ranges at screening;
  4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Humanity and Health Research Centre
Beijing 302 Hospital
Investigators
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Principal Investigator: George KK Lau, MD Humanity and Health GI and Liver Centre
More Information
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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
Additional relevant MeSH terms:
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Infection
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Sofosbuvir
Antiviral Agents
Anti-Infective Agents