NCT03071133

Brief Summary

An observational, postmarketing commitment following the marketing authorization for DCV Trio therapy in Japan

Trial Health

87
On Track

Trial Health Score

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

Enrollment
344

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

March 1, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2019

Completed
Last Updated

February 23, 2022

Status Verified

February 1, 2022

Enrollment Period

1 year

First QC Date

March 1, 2017

Last Update Submit

February 7, 2022

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (3)

  • Incidence of Aspartate Aminotransferase (AST) elevation

    measured by immunoassay

    Up to 36 weeks

  • Incidence of Alanine Aminotransferase (ALT) elevation

    measured by immunoassay

    Up to 36 weeks

  • Incidence of Total Bilirubin (tBili) elevation

    measured by immunoassay

    Up to 36 weeks

Secondary Outcomes (4)

  • Incidence of adverse drug reactions (ADRs) in HCV patients treated with DCV Trio therapy in Japan

    Up to 36 weeks

  • Proportion of patients with undetectable HCV RNA at 12 weeks post-treatment (SVR12)

    Up to 24 weeks

  • Proportion of patients with undetectable HCV RNA at 24 weeks post-treatment (SVR24)

    Up to 36 weeks

  • Percentage of patients to experience virologic breakthrough

    Up to 36 weeks

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients in Japan who are initiating treatment with DCV Trio therapy

You may qualify if:

  • Patients who are initiating the treatment with DCV Trio therapy under the approved indications, dosage, and administration

You may not qualify if:

  • Patients who use the DCV Trio off label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Tokyo, 1620814, Japan

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

March 1, 2017

First Posted

March 6, 2017

Study Start

January 1, 2018

Primary Completion

January 8, 2019

Study Completion

January 8, 2019

Last Updated

February 23, 2022

Record last verified: 2022-02

Locations

JP(1)