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Completed

NCT Number: NCT02583685

Switching Regimen in Treating Cirrhotic HCV GT1b Subjects

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.

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Key information

Conditions

Chronic Hepatitis C Infection

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PR4 + LDV/SOF + ASV 4 wk

Drug

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: Pegasys®, Copegus®, Harvoni®, Sunvepra®

PR4 + LDV/SOF + SMV 4 wk

Drug

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: Pegasys®, Copegus®, Harvoni®, OLYSIO®

PR4 + LDV/SOF + ASV 6 wk

Drug

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: Pegasys®, Copegus®, Harvoni®, Sunvepra®

PR4 + LDV/SOF + SMV 6 wk

Drug

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: Pegasys®, Copegus®, Harvoni®, OLYSIO®

PR4 + LDV/SOF + ASV 8 wk

Drug

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: Pegasys®, Copegus®, Harvoni®, Sunvepra®

PR4 + LDV/SOF + SMV 8 wk

Drug

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: Pegasys®, Copegus®, Harvoni®, OLYSIO®

PR4 + LDV/SOF + ASV 12 wk

Drug

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: Pegasys®, Copegus®, Harvoni®, Sunvepra®

PR4 + LDV/SOF + SMV 12 wk

Drug

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: Pegasys®, Copegus®, Harvoni®, OLYSIO®

Primary outcomes

  1. 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.

  2. Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)

    Time frame: Baseline up to Week 24

Secondary outcomes

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

    Time frame: Baseline up to Week 24

  2. Treatment adherence

    Time frame: Baseline to Week 12

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

  3. 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

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Humanity and Health Research Centre

Other

Collaborators

  • Beijing 302 Hospital
  • Nanfang Hospital, Southern Medical University

Registry information

Official study 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)

Acronym: SWITCH-1

Important dates

Study start
2015
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2015
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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