Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 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 2 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02482077
• Other study ID #: H&H_HCV G2 Study
• Status: Completed
• Phase: Phase 4
• First received: June 23, 2015
• Last updated: March 16, 2018
• Start date: January 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 genotypes 2 infection.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• 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:

1. Age equal to or greater than 18 years, with chronic genotype 2 HCV infection;

2. Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;

3. HCV RNA > 10,000 IU/mL at Screening;

4. Screening laboratory values within defined thresholds

5. Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion Criteria:

1. Pregnant or nursing female or male with pregnant female partner;

2. HIV or chronic hepatitis B virus (HBV) infection;

3. Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;

4. Active or recent history (= 1 year) of drug or alcohol abuse;

5. 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:
• SOF+RBV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and = 75 kg = 1200 mg).
• SOF+DCV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.
• LDV/SOF
Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) 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 after discontinuation of therapy	SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.	Post treatment Week 12
Primary	Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)		Baseline up to Week 24
Secondary	Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment		Baseline up to Week 24
Secondary	HCV RNA levels and change during and after treatment.		Baseline up to Week 24
Secondary	Proportion of participants with on-treatment virologic breakthrough and relapse	Viral breakthrough is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.	Baseline up to Week 24