NCT03366610

Brief Summary

The purpose of this study is to assess long-term outcomes in subjects previously treated with daclatasvir-based therapy for chronic Hepatitis-C (CHC)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
199

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

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 28, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 8, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
Last Updated

June 18, 2020

Status Verified

June 1, 2020

Enrollment Period

2 years

First QC Date

November 29, 2017

Last Update Submit

June 16, 2020

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Incidence of hepatic disease progression events

    up to 5 years

Secondary Outcomes (4)

  • Durability of virologic response

    up to 5 years

  • Change in liver stiffness

    baseline up to 5 years

  • Number of subjects with HCV sequence variants

    baseline up to 5 years

  • Distribution of HCV retreatment patterns

    baseline up to 5 years

Study Arms (1)

Patients Previously Treated with Daclatasvir-Based Regimens

Patients in China Previously Treated with Daclatasvir-Based Regimens

Other: Non-interventional

Interventions

Non-interventionalOTHER

Non-interventional

Patients Previously Treated with Daclatasvir-Based Regimens

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 1000 subjects diagnosed with CHC in China.

You may qualify if:

  • Males or females 18 years of age or older at initiation of prior DCV-based therapy
  • Previously treated with DCV (manufactured by BMS)-based therapy in combination with other HCV direct acting antivirals (DAAs) for at least 8 weeks
  • Must enroll in this study within 12 months of end of treatment of DCV-based therapy or within 6 months of protocol availability at the clinical site for subjects treated in the AI447036 or AI447114 studies

You may not qualify if:

  • \- N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Beijing, Beijing Municipality, China

Location

Related Links

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

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

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2017

First Posted

December 8, 2017

Study Start

April 28, 2017

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

June 18, 2020

Record last verified: 2020-06

Locations

CN(1)