NCT04111367

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 3, 2019

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

October 1, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

September 29, 2019

Last Update Submit

September 30, 2019

Conditions

Hepatitis C Virus Infection

Outcome Measures

Primary Outcomes (1)

  • 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.

    Posttreatment Week 12

Secondary Outcomes (1)

  • Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)

    Posttreatment Week 4

Study Arms (2)

Genotype 2 and 6 Subjects

EXPERIMENTAL

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: SeraprevirDrug: Sofosbuvir

Genotype 3 Subjects

EXPERIMENTAL

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: SeraprevirDrug: Sofosbuvir

Interventions

SeraprevirDRUG

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
Genotype 2 and 6 SubjectsGenotype 3 Subjects
SofosbuvirDRUG

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
Genotype 2 and 6 SubjectsGenotype 3 Subjects

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Beijing Ditan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

RECRUITING

Liuzhou General Hospital

Liuchow, Guangxi, China

RECRUITING

The first hospital of JILIN University.

Changchun, Jilin, 130000, China

RECRUITING

The First Affiliated Hospital Of Guangxi Medical University

Guangxi, Nanning, China

RECRUITING

MeSH Terms

Conditions

Hepatitis C

Interventions

Sofosbuvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Xuegang Wu

    Ginkgo Pharma Co., Ltd.

    STUDY DIRECTOR

Central Study Contacts

Junqi Niu

CONTACT

0431-88782013junqiniu@aliyun.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2019

First Posted

October 1, 2019

Study Start

April 3, 2019

Primary Completion

April 30, 2020

Study Completion

August 31, 2020

Last Updated

October 1, 2019

Record last verified: 2019-07

Locations

CN(4)