Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

Chronic Hepatitis C Infection Clinical Trial

Official title:

Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 3 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02576314
• Other study ID #: H&H_HCV G3 Study
• Status: Completed
• Phase: Phase 3
• First received: October 12, 2015
• Last updated: March 16, 2018
• Start date: May 2015
• Est. completion date: March 15, 2018

Study information

• Verified date: March 2018
• Source: Humanity and Health Research Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotype 3 infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 15, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age equal to or greater than 18 years, with chronic genotype 3 HCV infection;

• 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:

• Pregnant or nursing female;

• 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).

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Infection

Intervention

Drug:
• 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;

Locations

Country	Name	City	State
China	Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital	Beijing	Beijing
China	Humanity and Health GI and Liver Centre	Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Humanity and Health Research Centre	Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy	SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication	Post treatment Week 12
Primary	Incidence of adverse events leading to permanent discontinuation of study drug		Baseline up to Week 12
Secondary	Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment		Baseline up to Week 12
Secondary	HCV RNA levels and change during and after treatment		Baseline up to Week 12
Secondary	Treatment adherence	To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)	Baseline to Week 12
Secondary	Change in health related quality of life	To evaluate the change in health-related quality of life during treatment	Baseline to Week 24