A Phase 2 interventional study of Seraprevir and Sofosbuvir in Hepatitis C Virus Infection, sponsored by Ginkgopharma CO., LTD. Status unknown at 4 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-10-01.
Sponsored by Ginkgopharma CO., LTD · Phase 2, Interventional, and Treatment
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).
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 36 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Ginkgopharma CO., LTD is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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
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
Drug: Seraprevir · Drug: 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
Drug: Seraprevir · Drug: Sofosbuvir
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.
Also known as: GP205
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.
Also known as: sovaldi
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.
Time frame: Posttreatment Week 12
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.
Time frame: Posttreatment Week 4
This study is status unknown, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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