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

NCT04001608 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 206

Last updated 2019-06-28

No results posted yet for this study

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).

Conditions

  • Hepatitis C Virus Infection

Interventions

DRUG

Seraprevir

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

DRUG

Sofosbuvir

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

Sponsors & Collaborators

  • Ginkgopharma CO., LTD

    lead INDUSTRY

Principal Investigators

  • Xuegang Wu · Ginkgo Pharma Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-17
Primary Completion
2019-07-31
Completion
2019-11-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04001608 on ClinicalTrials.gov