Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 2,3,6 Hepatitis C Virus Infection Patients
- Registration Number
- NCT04111367
- Lead Sponsor
- Ginkgopharma CO., LTD
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 36
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.
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Genotype 2 and 6 Subjects Sofosbuvir 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 Seraprevir 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 Genotype 2 and 6 Subjects Seraprevir 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 Sofosbuvir 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
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12） Posttreatment Week 12 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4) Posttreatment Week 4 SVR4 is defined as HCV RNA \< LLOQ at 4 weeks following the last dose of study drug.
Trial Locations
- Locations (4)
Liuzhou General Hospital
🇨🇳Liuzhou, Guangxi Zhuang Autonomous Region, China
The first hospital of JILIN University.
🇨🇳Changchun, Jilin, China
Beijing Ditan Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China
The First Affiliated Hospital Of Guangxi Medical University
🇨🇳Guangxi, Nanning, China