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| Name | Class |
|---|---|
| Beijing 302 Hospital | OTHER |
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The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes 2 infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+RBV 8 wk | Experimental | Participants will receive SOF+RBV for 8 weeks. |
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| SOF+RBV 12 wk | Experimental | Participants will receive SOF+RBV for 12 weeks. |
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| SOF+DCV 8 wk | Experimental | Participants will receive SOF+DCV for 8 weeks. |
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| SOF+DCV 12 wk | Experimental | Participants will receive SOF+DCV for 12 weeks. |
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| LDV/SOF 8 wk | Experimental | Participants will receive LDV/SOF for 8 weeks. |
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| LDV/SOF 12 wk | Experimental | Participants will receive LDV/SOF for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF+RBV | Drug | Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with sustained virologic response 12 weeks 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 | |
| HCV RNA levels and change 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 KK Lau, MD | 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 | ||
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| D012254 | Ribavirin |
| C549273 | daclatasvir |
| C000595958 | ledipasvir, sofosbuvir drug combination |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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| SOF+DCV | Drug | Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily. |
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| LDV/SOF | Drug | Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily |
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| 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. | Baseline up to Week 24 |
| Humanity and Health GI and Liver Centre |
| Hong Kong |
| Hong Kong |
| 00852 |
| China |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |