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This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir in patients with Hepatitis C (HCV) genotype2,3,6. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Genotype 2 and 6 Subjects | Experimental | Genotype 2 and 6 Subjects will receive oral tablets of Seraprevir 200mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 12 |
|
| Genotype 3 Subjects | Experimental | Genotype 3 Subjects will receive oral tablets of Seraprevir 200mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 24 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seraprevir | Drug | Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12，the other group will receive the same dose for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12） | SVR12 is defined as HCV RNA < the lower limit of quantification (LLOQ; ie, < 15 IU/mL) 12 weeks following the last dose of study drug. | Posttreatment Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4) | SVR4 is defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug. | Posttreatment Week 4 |
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Inclusion Criteria:
Hepatitis C virus (HCV) genotype 2,3,6 infection (confirmed at screening). HCV RNA greater than 10,000 IU/mL at screening. Participant must be willing and able to comply with the protocol requirements. weight was more than 40 kg. age is between 18-75,either sex.
Exclusion Criteria:
Co-infection with hepatitis B virus or human immunodeficiency virus (HIV). Infection with HCV non-genotype 2,3,6,or Infection with mixed genotype,or Genotype cannot be confirmed.
Medical history of major functional organ transplantation. Suffering from serious blood system disease(such us Thalassemia/Sickle Cell Anemia).
Participation in a clinical study within 3 months prior to first dose
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Junqi Niu | Contact | 0431-88782013 | junqiniu@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuegang Wu | Ginkgo Pharma Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Ditan Hospital,Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
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| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
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|
| Sofosbuvir | Drug | Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12,the other group will receive the same dose for 24 weeks. |
|
|
| Liuzhou General Hospital | Recruiting | Liuzhou | Guangxi | China |
|
| The first hospital of JILIN University. | Recruiting | Changchun | Jilin | 130000 | China |
|
| The First Affiliated Hospital Of Guangxi Medical University | Recruiting | Guangxi | Nanning | China |
|
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |