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出境医 / 临床实验 / Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients

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

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Hepatitis C Virus Infection Drug: Seraprevir Drug: Sofosbuvir Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 206 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : October 17, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : November 30, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Seraprevir and sofosbuvir
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
Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12
Other Name: GP205

Drug: Sofosbuvir
Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12
Other Name: sovaldi
Outcome Measures
Primary Outcome Measures :
  1. Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12） [ Time Frame: 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 :
  1. Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 is defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.

  2. Percentage of Participants Achieving a On-treatment Virologic Response [ Time Frame: week 1,week 2,week 4,week8,week 12 ]
    Percentage of participants who achieved HCV RNA <LLOQ at week 1,week 2,week 4,week8,week 12.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
Show Show 22 study locations
Sponsors and Collaborators
Ginkgopharma CO., LTD
Investigators
Layout table for investigator information
Study Director: Xuegang Wu Ginkgo Pharma Co., Ltd.
Tracking Information
First Submitted Date  ICMJE June 21, 2019
First Posted Date  ICMJE June 28, 2019
Last Update Posted Date June 28, 2019
Actual Study Start Date  ICMJE October 17, 2018
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2019) 		Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12） [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2019)
  • Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4) [ Time Frame: Posttreatment Week 4 ]
    SVR4 is defined as HCV RNA < LLOQ at 4 weeks following the last dose of study drug.
  • Percentage of Participants Achieving a On-treatment Virologic Response [ Time Frame: week 1,week 2,week 4,week8,week 12 ]
    Percentage of participants who achieved HCV RNA <LLOQ at week 1,week 2,week 4,week8,week 12.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients
Official Title  ICMJE 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.
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hepatitis C Virus Infection
Intervention  ICMJE
  • Drug: Seraprevir
    Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12
    Other Name: GP205
  • Drug: Sofosbuvir
    Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12
    Other Name: sovaldi
Study Arms  ICMJE Experimental: Seraprevir and sofosbuvir
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.
Interventions:
  • Drug: Seraprevir
  • Drug: Sofosbuvir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: June 27, 2019) 		206
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2019
Estimated Primary Completion Date July 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04001608
Other Study ID Numbers  ICMJE GP205-1801
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ginkgopharma CO., LTD
Study Sponsor  ICMJE Ginkgopharma CO., LTD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Xuegang Wu Ginkgo Pharma Co., Ltd.
PRS Account Ginkgopharma CO., LTD
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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