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The collaborating pharmaceutical company will not wish to continue with the trial due to the internal issues in the company.
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| Name | Class |
|---|---|
| University of Maryland | OTHER |
| Emory University | OTHER |
| Beijing 302 Hospital | OTHER |
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There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg) in this study but the treatment duration may be different depending on patients' response to the antiviral therapy and whether patients have liver cirrhosis. If patients have no cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If patients have cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be 8 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+DCV+SMV 3-4 wks | Experimental | Patients without cirrhosis will receive sofosbuvir, daclatasvir and simeprevir for (a) 3 weeks if HCV viral load on day 2 is <500 IU/ml or (b) 4 weeks if HCV viral load on day 2 is >500 IU/ml. |
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| SOF+DCV+SMV 6-8 wks | Experimental | Patients with cirrhosis and CP-A will receive sofosbuvir, daclatasvir and simeprevir (a) 6 weeks if HCV VL on day 2 is <500 IU/ml or (b) 8 weeks if HCV VL on day 2 is >500 IU/ml. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF+DCV+SMV | Drug | Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with plasma HCV viral load below the lower limit of quantification for 12 weeks after treatment completion (SVR12) | SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug. | Post treatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of adverse events | Baseline up to Week 24 | |
| Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment | Baseline up to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George LAU, MD | Humanity & Health Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanity and Health Medical Centre | Hong Kong | 00852 | Hong Kong |
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| Kinetics of circulating HCV RNA during treatment and after treatment discontinuation | Baseline up to Week 24 |
| Proportion of participants with on-treatment virologic breakthrough and relapse | Viral breakthrough is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR up to 24 weeks. | Baseline up to Week 24 |