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Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

Primary Purpose

Chronic Hepatitis C Infection

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

sofosbuvir and daclatasvir

ledipasvir/sofosbuvir

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection

Eligibility Criteria

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

Inclusion Criteria:

Age equal to or greater than 18 years, with chronic genotype 3 HCV infection;
Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
HCV RNA > 10,000 IU/mL at Screening;
Screening laboratory values within defined thresholds;
Negative pregnancy test at baseline (females of childbearing potential only);
Use of two effective contraception methods if female of childbearing potential or sexually active male.

Exclusion Criteria:

Pregnant or nursing female;
HIV infection or HBV infection (HBcAb and HBsAg positive);
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).

Sites / Locations

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
Humanity and Health GI and Liver Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Sofosbuvir and Daclatasvir

Ledipasvir/sofosbuvir

Arm Description

Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.

Participants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily for 12 weeks.

Outcomes

Primary Outcome Measures

Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy

SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication

Incidence of adverse events leading to permanent discontinuation of study drug

Secondary Outcome Measures

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

HCV RNA levels and change during and after treatment

Treatment adherence

To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)

Change in health related quality of life

To evaluate the change in health-related quality of life during treatment

Full Information

NCT ID

NCT02576314

First Posted

October 12, 2015

Last Updated

March 16, 2018

Sponsor

Humanity and Health Research Centre

Collaborators

Beijing 302 Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02576314

Brief Title

Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

Official Title

Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 3 Infection

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

December 31, 2017 (Actual)

Study Completion Date

March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Humanity and Health Research Centre

Collaborators

Beijing 302 Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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 genotype 3 infection.

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 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sofosbuvir and Daclatasvir

Arm Type

Active Comparator

Arm Description

Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks.

Arm Title

Ledipasvir/sofosbuvir

Arm Type

Active Comparator

Arm Description

Participants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily for 12 weeks.

Intervention Type

Drug

Intervention Name(s)

sofosbuvir and daclatasvir

Other Intervention Name(s)

Sovaldi®, PSI-7977, GS-7977, Daklinza®, BMS-790052

Intervention Description

Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once daily.

Intervention Type

Drug

Intervention Name(s)

ledipasvir/sofosbuvir

Other Intervention Name(s)

Harvoni®, GS-5885, GS-7977, PSI-7977

Intervention Description

Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally. once daily;

Primary Outcome Measure Information:

Title

Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy

Description

SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication

Time Frame

Post treatment Week 12

Title

Incidence of adverse events leading to permanent discontinuation of study drug

Time Frame

Baseline up to Week 12

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline up to Week 12

Title

HCV RNA levels and change during and after treatment

Time Frame

Baseline up to Week 12

Title

Treatment adherence

Description

To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)

Time Frame

Baseline to Week 12

Title

Change in health related quality of life

Description

To evaluate the change in health-related quality of life during treatment

Time Frame

Baseline to Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age equal to or greater than 18 years, with chronic genotype 3 HCV infection; Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen; HCV RNA > 10,000 IU/mL at Screening; Screening laboratory values within defined thresholds; Negative pregnancy test at baseline (females of childbearing potential only); Use of two effective contraception methods if female of childbearing potential or sexually active male. Exclusion Criteria: Pregnant or nursing female; HIV infection or HBV infection (HBcAb and HBsAg positive); 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George Lau, MD

Organizational Affiliation

Humanity and Health GI and Liver Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100039

Country

China

Facility Name

Humanity and Health GI and Liver Centre

City

Hong Kong

State/Province

Hong Kong

ZIP/Postal Code

00852

Country

China

12. IPD Sharing Statement

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Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients

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