Triple Combination DAAs for Treating HCV GT1b Subjects

Triple Combination DAAs for Ultra Short Duration Therapy for HCV Genotype 1b in Chinese (SODAPI II Study)

There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg) in this study but the treatment duration may be different depending on patients' response to the antiviral therapy and whether patients have liver cirrhosis. If patients have no cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If patients have cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be 8 weeks.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Hepatitis C Infection
• Intervention / Treatment: Drug: SOF+DCV+SMV

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 00852
    • Humanity and Health Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. HCV RNA positive >2000 IU/ml or NAT POC positive
2. Genotype 1b
3. CP score ≤6

Exclusion Criteria:

1. Pregnant or nursing female or male with pregnant female partner
2. Hematologic or biochemical parameters at Screening outside the protocol- specified requirements
3. Active or recent history (≤ 1 year) of drug or alcohol abuse
4. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
5. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOF+DCV+SMV 3-4 wks; Patients without cirrhosis will receive sofosbuvir, daclatasvir and simeprevir for (a) 3 weeks if HCV viral load on day 2 is <500 IU/ml or (b) 4 weeks if HCV viral load on day 2 is >500 IU/ml.	Drug: 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.
Experimental: SOF+DCV+SMV 6-8 wks; Patients with cirrhosis and CP-A will receive sofosbuvir, daclatasvir and simeprevir (a) 6 weeks if HCV VL on day 2 is <500 IU/ml or (b) 8 weeks if HCV VL on day 2 is >500 IU/ml.	Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with plasma HCV viral load below the lower limit of quantification for 12 weeks after treatment completion (SVR12)	SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.	Post treatment Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency and severity of adverse events		Baseline up to Week 24
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment		Baseline up to Week 24
Kinetics of circulating HCV RNA during treatment and after treatment discontinuation		Baseline up to Week 24
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 up to 24 weeks.	Baseline up to Week 24

Collaborators and Investigators

• Sponsor: Humanity and Health Research Centre
• Collaborators: University of Maryland; Emory University; Beijing 302 Hospital
• Investigators: Principal Investigator: George Lau, MD, Humanity & Health Medical Centre

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: October 5, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 13, 2016

Study Record Updates

• Last Update Posted (Actual): May 12, 2017
• Last Update Submitted That Met QC Criteria: May 11, 2017
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: H&H_SODAPI II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided