Not provided
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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 genotype 3 infection.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sofosbuvir and Daclatasvir | Active Comparator | Participants will receive Sofosbuvir (SOF) 400 mg and Daclatasvir (DCV) 60 mg daily for 12 weeks. |
|
| Ledipasvir/sofosbuvir | Active Comparator | Participants will receive Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet daily for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sofosbuvir and daclatasvir | Drug | Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once 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 < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication | Post treatment Week 12 |
| Incidence of adverse events leading to permanent discontinuation of study drug | Baseline up to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment | Baseline up to Week 12 | |
| HCV RNA levels and change during and after treatment | Baseline up to Week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| George 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 | ||
Not provided
| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C549273 | daclatasvir |
| C000595958 | ledipasvir, sofosbuvir drug combination |
| C586541 | ledipasvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ledipasvir/sofosbuvir | Drug | Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally. once daily; |
|
|
| Treatment adherence | To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation) | Baseline to Week 12 |
| Change in health related quality of life | To evaluate the change in health-related quality of life during treatment | Baseline 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 |