Switching Regimen in Treating Cirrhotic HCV GT1b Subjects
NCT ID: NCT02583685
Last Updated: 2025-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
138 participants
INTERVENTIONAL
2015-05-15
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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.
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.
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.
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.
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.
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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Beijing 302 Hospital
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Humanity and Health Research Centre
OTHER
Responsible Party
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Principal Investigators
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George Lau
Role: PRINCIPAL_INVESTIGATOR
Humanity and Health GI and Liver Centre
Locations
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Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
Beijing, Beijing Municipality, China
Humanity and Health GI and Liver Centre
Hong Kong, Hong Kong, China
Countries
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Other Identifiers
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H&H_SWITCH-1
Identifier Type: -
Identifier Source: org_study_id
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