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| Name | Class |
|---|---|
| Beijing 302 Hospital | OTHER |
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This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV genotype 1b treatment-experienced patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOF+PEG+RBV | Experimental | Participants with HCV genotype 1b infection will receive Sofosbuvir (SOF) 400 mg +PEG+RBV for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SOF+PEG+RBV | Drug | Sofosbuvir (SOF) 400 mg tablet is administered orally once daily; Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection; Ribavirin (RBV) was administered as a tablet orally according to body weight (< 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) | 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) | Adverse events leading to permanent discontinuation of study drug(s) | Baseline up to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HCV RNA From Baseline to Week 12 | Baseline up to Week 24 | |
| Proportion of participants with on-treatment virologic breakthrough and relapse | Baseline up to Week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Lau, MD | Humanity and Health GI and Liver Centre | Principal Investigator |
| Guofeng Chen, MD | 302 Hospital | 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 |
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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|
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| 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 |