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Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (SWITCH-1)

Primary Purpose

Chronic Hepatitis C Infection

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
PR4 + LDV/SOF + ASV 4 wk
PR4 + LDV/SOF + SMV 4 wk
PR4 + LDV/SOF + ASV 6 wk
PR4 + LDV/SOF + SMV 6 wk
PR4 + LDV/SOF + ASV 8 wk
PR4 + LDV/SOF + SMV 8 wk
PR4 + LDV/SOF + ASV 12 wk
PR4 + LDV/SOF + SMV 12 wk
Sponsored by
Humanity and Health Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  • Individuals with chronic HCV GT1b infection;
  • HCV RNA ≥ 10000 IU/mL at screening;
  • Received 4 weeks pegylated interferon plus ribavirin (PR4) therapy and are intolerant to PR4;
  • Cirrhosis determination; a liver biopsy may be required;
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male;

Exclusion Criteria:

  • Pregnant or nursing female or male with pregnant female partner;
  • HIV or HBV co-infection;
  • Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;
  • Active or recent history (≤ 1 year) of drug or alcohol abuse;
  • 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

  • Liver Fibrosis Diagnosis and Treatment Centre, 302 HospitalRecruiting
  • Humanity and Health GI and Liver CentreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

PR4 + LDV/SOF + ASV 4 wk

PR4 + LDV/SOF + SMV 4 wk

PR4 + LDV/SOF + ASV 6 wk

PR4 + LDV/SOF + SMV 6 wk

PR4 + LDV/SOF + ASV 8 wk

PR4 + LDV/SOF + SMV 8 wk

PR4 + LDV/SOF + ASV 12 wk

PR4 + LDV/SOF + SMV 12 wk

Arm Description

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 2 will receive LDV/SOF + ASV for 4 weeks.

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 2 will receive LDV/SOF + SMV for 4 weeks.

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 4 will receive LDV/SOF + ASV for 6 weeks.

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 4 will receive LDV/SOF + SMV for 6 weeks.

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA > 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + ASV for 8 weeks.

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA > 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + SMV for 8 weeks.

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <2 log drop by week 4 will receive LDV/SOF + ASV for 12 weeks.

Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <2 log drop by week 4 will receive LDV/SOF + SMV 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 < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)

Secondary Outcome Measures

Proportion of participants with unquantifiable HCV viral load at specified time points 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 evaluated with questionnaires
To evaluate the change in health-related quality of life during and after treatment with questionnaires
Change in mental health evaluated with questionnaires
To evaluate the change in mental health during and after treatment with questionnaires
Liver disease progression
Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.

Full Information

First Posted
October 12, 2015
Last Updated
August 27, 2021
Sponsor
Humanity and Health Research Centre
Collaborators
Beijing 302 Hospital, Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT02583685
Brief Title
Switching Regimen in Treating Cirrhotic HCV GT1b Subjects
Acronym
SWITCH-1
Official Title
Efficacy and Safety of Switching From Pegylated Interferon/Ribavirin (PR) to Direct-acting Antiviral Agents (DAAs) for Chinese With CHC Genotype 1b Infection (SWITCH-1)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2015 (undefined)
Primary Completion Date
October 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Humanity and Health Research Centre
Collaborators
Beijing 302 Hospital, Nanfang Hospital, Southern Medical University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with CHC genotype 1b infection, who are interferon/ribavirin-intolerant.

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
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PR4 + LDV/SOF + ASV 4 wk
Arm Type
Experimental
Arm Description
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 2 will receive LDV/SOF + ASV for 4 weeks.
Arm Title
PR4 + LDV/SOF + SMV 4 wk
Arm Type
Experimental
Arm Description
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 2 will receive LDV/SOF + SMV for 4 weeks.
Arm Title
PR4 + LDV/SOF + ASV 6 wk
Arm Type
Experimental
Arm Description
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 4 will receive LDV/SOF + ASV for 6 weeks.
Arm Title
PR4 + LDV/SOF + SMV 6 wk
Arm Type
Experimental
Arm Description
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 4 will receive LDV/SOF + SMV for 6 weeks.
Arm Title
PR4 + LDV/SOF + ASV 8 wk
Arm Type
Experimental
Arm Description
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA > 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + ASV for 8 weeks.
Arm Title
PR4 + LDV/SOF + SMV 8 wk
Arm Type
Experimental
Arm Description
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA > 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + SMV for 8 weeks.
Arm Title
PR4 + LDV/SOF + ASV 12 wk
Arm Type
Experimental
Arm Description
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <2 log drop by week 4 will receive LDV/SOF + ASV for 12 weeks.
Arm Title
PR4 + LDV/SOF + SMV 12 wk
Arm Type
Experimental
Arm Description
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <2 log drop by week 4 will receive LDV/SOF + SMV for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
PR4 + LDV/SOF + ASV 4 wk
Other Intervention Name(s)
Pegasys®, Copegus®, Harvoni®, Sunvepra®
Intervention Description
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
Intervention Type
Drug
Intervention Name(s)
PR4 + LDV/SOF + SMV 4 wk
Other Intervention Name(s)
Pegasys®, Copegus®, Harvoni®, OLYSIO®
Intervention Description
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
Intervention Type
Drug
Intervention Name(s)
PR4 + LDV/SOF + ASV 6 wk
Other Intervention Name(s)
Pegasys®, Copegus®, Harvoni®, Sunvepra®
Intervention Description
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
Intervention Type
Drug
Intervention Name(s)
PR4 + LDV/SOF + SMV 6 wk
Other Intervention Name(s)
Pegasys®, Copegus®, Harvoni®, OLYSIO®
Intervention Description
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
Intervention Type
Drug
Intervention Name(s)
PR4 + LDV/SOF + ASV 8 wk
Other Intervention Name(s)
Pegasys®, Copegus®, Harvoni®, Sunvepra®
Intervention Description
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
Intervention Type
Drug
Intervention Name(s)
PR4 + LDV/SOF + SMV 8 wk
Other Intervention Name(s)
Pegasys®, Copegus®, Harvoni®, OLYSIO®
Intervention Description
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
Intervention Type
Drug
Intervention Name(s)
PR4 + LDV/SOF + ASV 12 wk
Other Intervention Name(s)
Pegasys®, Copegus®, Harvoni®, Sunvepra®
Intervention Description
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
Intervention Type
Drug
Intervention Name(s)
PR4 + LDV/SOF + SMV 12 wk
Other Intervention Name(s)
Pegasys®, Copegus®, Harvoni®, OLYSIO®
Intervention Description
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet 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 < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
Time Frame
Post treatment Week 12
Title
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
Time Frame
Baseline up to Week 24
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 24
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 evaluated with questionnaires
Description
To evaluate the change in health-related quality of life during and after treatment with questionnaires
Time Frame
Up to Posttreatment Week 24
Title
Change in mental health evaluated with questionnaires
Description
To evaluate the change in mental health during and after treatment with questionnaires
Time Frame
Up to Posttreatment Week 24
Title
Liver disease progression
Description
Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.
Time Frame
Up to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals with chronic HCV GT1b infection; HCV RNA ≥ 10000 IU/mL at screening; Received 4 weeks pegylated interferon plus ribavirin (PR4) therapy and are intolerant to PR4; Cirrhosis determination; a liver biopsy may be required; Use of highly effective contraception methods if female of childbearing potential or sexually active male; Exclusion Criteria: Pregnant or nursing female or male with pregnant female partner; HIV or HBV co-infection; Hematologic or biochemical parameters at Screening outside the protocol- specified requirements; Active or recent history (≤ 1 year) of drug or alcohol abuse; 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen WANG, MD, PhD
Phone
+85228613777
Email
doc_chengwang@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yudong WANG, PhD
Phone
+85228613777
Email
ydwang@connect.hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Lau
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
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guofeng Chen, MD
Phone
(8610)66933427
Email
guofengchen302@163.com
First Name & Middle Initial & Last Name & Degree
George KK Lau, MD
First Name & Middle Initial & Last Name & Degree
Guofeng Chen, MD
Facility Name
Humanity and Health GI and Liver Centre
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
00852
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George KK Lau, MD
Phone
(852)28613777
Email
gkklau@netvigator.com
First Name & Middle Initial & Last Name & Degree
George KK Lau, MD

12. IPD Sharing Statement

Learn more about this trial

Switching Regimen in Treating Cirrhotic HCV GT1b Subjects

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