Switching Regimen in Treating Cirrhotic HCV GT1b Subjects
SWITCH-1
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)
1 other identifier
interventional
138
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2015
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 15, 2015
CompletedFirst Submitted
Initial submission to the registry
October 12, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2024
CompletedMarch 26, 2025
March 1, 2025
9.5 years
October 12, 2015
March 21, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
Post treatment Week 12
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
Baseline up to Week 24
Secondary Outcomes (5)
Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
Baseline up to Week 24
Treatment adherence
Baseline to Week 12
Change in health related quality of life evaluated with questionnaires
Up to Posttreatment Week 24
Change in mental health evaluated with questionnaires
Up to Posttreatment Week 24
Liver disease progression
Up to 10 years
Study Arms (8)
PR4 + LDV/SOF + ASV 4 wk
EXPERIMENTALParticipants 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.
PR4 + LDV/SOF + SMV 4 wk
EXPERIMENTALParticipants 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.
PR4 + LDV/SOF + ASV 6 wk
EXPERIMENTALParticipants 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.
PR4 + LDV/SOF + SMV 6 wk
EXPERIMENTALParticipants 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.
PR4 + LDV/SOF + ASV 8 wk
EXPERIMENTALParticipants 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.
PR4 + LDV/SOF + SMV 8 wk
EXPERIMENTALParticipants 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.
PR4 + LDV/SOF + ASV 12 wk
EXPERIMENTALParticipants 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.
PR4 + LDV/SOF + SMV 12 wk
EXPERIMENTALParticipants 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.
Interventions
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.
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.
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.
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Humanity and Health Research Centrelead
- Beijing 302 Hospitalcollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
Study Sites (2)
Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
Beijing, Beijing Municipality, 100039, China
Humanity and Health GI and Liver Centre
Hong Kong, Hong Kong, 00852, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
George Lau
Humanity and Health GI and Liver Centre
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2015
First Posted
October 22, 2015
Study Start
May 15, 2015
Primary Completion
October 31, 2024
Study Completion
October 31, 2024
Last Updated
March 26, 2025
Record last verified: 2025-03