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

August 27, 2021 updated by: Humanity and Health Research Centre

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Recruiting
        • Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
        • Principal Investigator:
          • Guofeng Chen, MD
        • Principal Investigator:
          • George KK Lau, MD
        • Contact:
    • Hong Kong
      • Hong Kong, Hong Kong, China, 00852
        • Recruiting
        • Humanity and Health GI and Liver Centre
        • Contact:
        • Principal Investigator:
          • George KK Lau, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PR4 + LDV/SOF + ASV 4 wk
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.
Drug: PR4 + LDV/SOF + ASV 4 wk
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.
Other Names:
  • Harvoni®
  • Pegasys®
  • Copegus®
  • Sunvepra®
Experimental: PR4 + LDV/SOF + SMV 4 wk
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.
Drug: PR4 + LDV/SOF + SMV 4 wk
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.
Other Names:
  • Harvoni®
  • Pegasys®
  • Copegus®
  • OLYSIO®
Experimental: PR4 + LDV/SOF + ASV 6 wk
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.
Drug: PR4 + LDV/SOF + ASV 6 wk
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.
Other Names:
  • Harvoni®
  • Pegasys®
  • Copegus®
  • Sunvepra®
Experimental: PR4 + LDV/SOF + SMV 6 wk
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.
Drug: PR4 + LDV/SOF + SMV 6 wk
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.
Other Names:
  • Harvoni®
  • Pegasys®
  • Copegus®
  • OLYSIO®
Experimental: PR4 + LDV/SOF + ASV 8 wk
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.
Drug: PR4 + LDV/SOF + ASV 8 wk
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.
Other Names:
  • Harvoni®
  • Pegasys®
  • Copegus®
  • Sunvepra®
Experimental: PR4 + LDV/SOF + SMV 8 wk
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.
Drug: PR4 + LDV/SOF + SMV 8 wk
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.
Other Names:
  • Harvoni®
  • Pegasys®
  • Copegus®
  • OLYSIO®
Experimental: PR4 + LDV/SOF + ASV 12 wk
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.
Drug: PR4 + LDV/SOF + ASV 12 wk
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.
Other Names:
  • Harvoni®
  • Pegasys®
  • Copegus®
  • Sunvepra®
Experimental: PR4 + LDV/SOF + SMV 12 wk
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.
Drug: PR4 + LDV/SOF + SMV 12 wk
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.
Other Names:
  • Harvoni®
  • Pegasys®
  • Copegus®
  • OLYSIO®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy
Time Frame: Post treatment Week 12
SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.
Post treatment Week 12
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
Time Frame: Baseline up to Week 24
Baseline up to Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment adherence
Time Frame: Baseline to Week 12
To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)
Baseline to Week 12
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
Time Frame: Baseline up to Week 24
Baseline up to Week 24
Change in health related quality of life evaluated with questionnaires
Time Frame: Up to Posttreatment Week 24
To evaluate the change in health-related quality of life during and after treatment with questionnaires
Up to Posttreatment Week 24
Change in mental health evaluated with questionnaires
Time Frame: Up to Posttreatment Week 24
To evaluate the change in mental health during and after treatment with questionnaires
Up to Posttreatment Week 24
Liver disease progression
Time Frame: Up to 10 years
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.
Up to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanity and Health Research Centre

Collaborators

Beijing 302 Hospital
Nanfang Hospital of Southern Medical University

Investigators

  • Principal Investigator: George Lau, Humanity and Health GI and Liver Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

October 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 12, 2015

First Submitted That Met QC Criteria

October 20, 2015

First Posted (Estimate)

October 22, 2015

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 27, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H&H_SWITCH-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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