Triple Combination DAAs for Treating HCV GT1b Subjects

Phase 2

Withdrawn

• Conditions: Chronic Hepatitis C Infection
• Interventions: Drug: SOF+DCV+SMV

• Registration Number: NCT02932293
• Lead Sponsor: Humanity and Health Research Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-10
• Study First Submitted: 2016-10-05
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-13
• Study Start: 2016-12
• Last Update Submitted: 2017-05-11
• Last Update Posted: 2017-05-12
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOF+DCV+SMV 6-8 wks	SOF+DCV+SMV	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.
SOF+DCV+SMV 3-4 wks	SOF+DCV+SMV	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Baseline up to Week 24	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.

Trial Locations

Locations (1)

Humanity and Health Medical Centre; 🇭🇰 Hong Kong, Hong Kong