Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients

Study Overview
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Brief Summary
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This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir administered for 12 weeks in patients with Hepatitis C (HCV) genotype1. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).

Official Title
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A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 1 Hepatitis C Virus Infection.

Conditions
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Hepatitis C Virus Infection

Intervention / Treatment
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* Drug: Seraprevir
* Drug: Sofosbuvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hepatitis C virus (HCV) genotype 1 infection (confirmed at screening). HCVRNA 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 1,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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seraprevir and sofosbuvir<br>Subjects will receive oral tablets of Seraprevir 100mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 12. | Drug: Seraprevir<br>* Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12<br>* Other names: GP205;Drug: Sofosbuvir<br>* Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12<br>* Other names: sovaldi;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Percentage of Participants Achieving a On-treatment Virologic Response | Percentage of participants who achieved HCV RNA <LLOQ at week 1,week 2,week 4,week8,week 12. | week 1,week 2,week 4,week8,week 12 |