Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects

Chronic Hepatitis C Infection Clinical Trial

Official title:

Effect of Triple Direct Acting Antiviral Agents (DAAs) for Non-cirrhotic Subjects With Chronic HCV G1b Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470858
• Other study ID #: H&H_Triple Therapy_1
• Status: Completed
• Phase: Phase 2
• First received: June 5, 2015
• Last updated: February 26, 2016
• Start date: January 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Humanity & Healthy GI and Liver Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

The study is designed to test the hypothesis that the addition of a protease inhibitor to dual NS5a-NS5B nucleoside prodrug analog will enhance antiviral efficacy and hence shorten the treatment duration to 3 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

• HCV RNA level > 10,000 and < 10,000,000 IU/ml at Screening;

• Rapid response to triple DAAs therapy with less than 500 IU/ml plasma HCV RNA level at Day 2;

• No evidence of cirrhosis. Cirrhosis defined as any 1 of the following, within 6 months of study entry:

1. Liver biopsy showing cirrhosis;

2. Fibroscan showing cirrhosis or results>12.5 kPa ;

3. FibroTest® score >0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) >2 during screening.

Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner;

• HIV or chronic hepatitis B virus (HBV) infection;

• 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);

• History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• LDV/SOF+ASV
Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed-dose combination (FDC) tablet; administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.
• SOF+DCV+SMV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
• SOF+DCV+ASV
Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.

Locations

Country	Name	City	State
China	Humanity and Health GI and Liver Centre	Hong Kong	Hong Kong

Sponsors (3)

Lead Sponsor	Collaborator
Humanity & Healthy GI and Liver Centre	Beijing 302 Hospital, Emory University

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)	SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.	Post treatment Week 12	No
Primary	Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)		Baseline up to Week 24	No
Secondary	Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment.		Baseline up to Week 24	No
Secondary	HCV RNA levels and change during and after treatment.		Baseline up to Week 24	No
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	No