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Triple Combination DAAs for Treating HCV GT1b Subjects

Primary Purpose

Chronic Hepatitis C Infection

Status

Withdrawn

Phase

Phase 2

Locations

Hong Kong

Study Type

Interventional

Intervention

SOF+DCV+SMV

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Pregnant or nursing female or male with pregnant female partner
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.

Sites / Locations

Humanity and Health Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SOF+DCV+SMV 3-4 wks

SOF+DCV+SMV 6-8 wks

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Frequency and severity of adverse events

Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment

Kinetics of circulating HCV RNA during treatment and after treatment discontinuation

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.

Full Information

NCT ID

NCT02932293

First Posted

October 5, 2016

Last Updated

May 11, 2017

Sponsor

Humanity and Health Research Centre

Collaborators

University of Maryland, Emory University, Beijing 302 Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02932293

Brief Title

Triple Combination DAAs for Treating HCV GT1b Subjects

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Withdrawn

Why Stopped

The collaborating pharmaceutical company will not wish to continue with the trial due to the internal issues in the company.

Study Start Date

December 2016 (Anticipated)

Primary Completion Date

December 2017 (Anticipated)

Study Completion Date

December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Humanity and Health Research Centre

Collaborators

University of Maryland, Emory University, Beijing 302 Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis C Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SOF+DCV+SMV 3-4 wks

Arm Type

Experimental

Arm Description

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.

Arm Title

SOF+DCV+SMV 6-8 wks

Arm Type

Experimental

Arm Description

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.

Intervention Type

Drug

Intervention Name(s)

SOF+DCV+SMV

Intervention Description

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.

Primary Outcome Measure Information:

Title

Proportion of participants with plasma HCV viral load below the lower limit of quantification for 12 weeks after treatment completion (SVR12)

Description

SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.

Time Frame

Post treatment Week 12

Secondary Outcome Measure Information:

Title

Frequency and severity of adverse events

Time Frame

Baseline up to Week 24

Title

Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment

Time Frame

Baseline up to Week 24

Title

Kinetics of circulating HCV RNA during treatment and after treatment discontinuation

Time Frame

Baseline up to Week 24

Title

Proportion of participants with on-treatment virologic breakthrough and relapse

Description

Time Frame

Baseline up to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HCV RNA positive >2000 IU/ml or NAT POC positive Genotype 1b CP score ≤6 Exclusion Criteria: Pregnant or nursing female or male with pregnant female partner 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George LAU, MD

Organizational Affiliation

Humanity & Health Medical Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Humanity and Health Medical Centre

City

Hong Kong

ZIP/Postal Code

00852

Country

Hong Kong

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Triple Combination DAAs for Treating HCV GT1b Subjects

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