Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Beijing 302 Hospital | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PR4 + LDV/SOF + ASV 4 wk | Experimental | 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 + SMV 4 wk | Experimental | 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 + ASV 6 wk | Experimental | 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 + SMV 6 wk | Experimental | 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 + ASV 8 wk | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment | Baseline up to Week 24 | |
| Treatment adherence | To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| George Lau | Humanity and Health GI and Liver Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital | Beijing | Beijing Municipality | 100039 | China | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| PR4 + LDV/SOF + SMV 8 wk | Experimental | 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 + ASV 12 wk | Experimental | 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 + SMV 12 wk | Experimental | 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 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. |
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
|
| 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. |
|
|
| Baseline to Week 12 |
| 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 | Up to Posttreatment Week 24 |
| Change in mental health evaluated with questionnaires | To evaluate the change in mental health during and after treatment with questionnaires | Up to Posttreatment Week 24 |
| 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. | Up to 10 years |
| Humanity and Health GI and Liver Centre |
| Hong Kong |
| Hong Kong |
| 00852 |
| China |
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| C000595958 | ledipasvir, sofosbuvir drug combination |
| D000069616 | Simeprevir |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D013449 | Sulfonamides |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided