SOF Plus DCV in Treating Chinese Treatment-experienced HCV Patients

NCT02473211 | Completed Phase 2

• 1 other identifier: H&H_SOF plus DCV treatment
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Hepatitis C Infection

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with sustained virologic response 12 weeks after the end of treatment (SVR12)

  SVR12 is defined as HCV RNA \< the lower limit of quantitation (LLOQ) (15 IU/ml) 12 weeks following the last dose of study drug

  Post treatment Week 12

Study Arms (1)

SOF+DCV

EXPERIMENTAL

Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.

Drug: Sofosbuvir; Drug: Daclatasvir

Interventions

Sofosbuvir DRUG

Sofosbuvir 400 mg tablet administered once daily

Also known as: GS-7977

SOF+DCV

Daclatasvir DRUG

Daclatasvir 60mg tablet administered once daily

Also known as: BMS-790052

SOF+DCV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Humanity and Health Research Centre: lead
• Beijing 302 Hospital: collaborator

Study Sites (2)

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital

Beijing, Beijing Municipality, 100039, China

Location

Humanity and Health GI and Liver Centre

Hong Kong, Hong Kong, 00852, China

Location

MeSH Terms

Interventions

Sofosbuvir; daclatasvir

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• George KK Lau, MD

  Humanity and Health GI and Liver Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 16, 2015
• Study Start: January 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: March 15, 2018
• Last Updated: March 19, 2018

Record last verified: 2018-03

Locations

CN (2)