NCT02250001

Brief Summary

The primary objective of this study is: To evaluate the real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of DCV/ASV dual therapy in Japanese patients chronically infected with HCV GT-1.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,974

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Typical duration 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

September 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2014

Completed
4 days until next milestone

Study Start

First participant enrolled

September 30, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2017

Completed
Last Updated

May 3, 2017

Status Verified

May 1, 2017

Enrollment Period

2.3 years

First QC Date

September 24, 2014

Last Update Submit

May 1, 2017

Conditions

Chronic Hepatitis C

Keywords

HCV

Outcome Measures

Primary Outcomes (1)

  • The real-world safety, specifically the incidence rates of hepatic toxicity, pyrexia, and resistance, of Daclatasvir/Asunaprevir (DCV/ASV) dual therapy in Japanese patients chronically infected with Hepatitis C virus Genotype 1 (HCV GT-1)

    28 weeks

Secondary Outcomes (1)

  • Antiviral activity as determined by the proportion of patients with sustained virologic response at 24 weeks post-treatment Sustained virologic response at 24 weeks post-treatment (SVR24)

    48 weeks

Study Arms (1)

Treatment with DCV/ASV

Patients who are beginning to receive the treatment with DCV/ASV under the approved indications, dosage, and administration will be included in this study

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

University hospitals, General hospitals, and clinics that have relevant departments, such as Liver Internal medicine, Gastroenterological medicine, Internal medicine, etc, where the surveillance drug is mainly prescribed

You may qualify if:

  • Patients who are initiating DCV and ASV treatment for the first time under the approved indications, dosage, and administration will be included in this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Chuo-ku, Tokyo, 104-0033, Japan

Location

Related Links

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Target Duration
48 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2014

First Posted

September 26, 2014

Study Start

September 30, 2014

Primary Completion

January 20, 2017

Study Completion

January 20, 2017

Last Updated

May 3, 2017

Record last verified: 2017-05

Locations

JP(1)