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

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.

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04001608

Enrollment

206

Registered

2019-06-28

Start date

2018-10-17

Completion date

2019-11-30

Last updated

2019-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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).

Interventions

DRUGSeraprevir

Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12

DRUGSofosbuvir

Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Percentage of Participants Achieving a On-treatment Virologic Response	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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026