Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2974 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2017-01-20

Brief Summary

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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.

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Detailed Description

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Time Perspective: Other - For patients who are treated before the contract between Bristol-Myers Kabushiki Kaisha (BMKK) and the treating physician is initiated, patient data will be collected retrospectively after the contract is signed. Data will be collected prospectively for patients who initiate DCV/ASV treatment after the contract is initiated

Patient Registry study - Yes; 48 weeks (Treatment: 24 weeks, Follow up: 24 weeks)

Conditions

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Chronic Hepatitis C

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No