Study of Daclatasvir-based Therapy in Chinese Participants With Chronic Hepatitis C (CHC)

Bristol-Myers Squibb3 enrolled

Overview

Study is a non-interventional, prospective, multicenter post marketing surveillance study to determine the safety of daclatasvir based therapy

Study Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Hepatitis C

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Participants 18 years of age and older * Participants with Chronic Hepatitis C virus (CHC) who are eligible for treatment with branded DCV-based therapy as indicated in the locally approved label Exclusion Criteria: * Participants under the age of 18 Other protocol defined inclusion/exclusion criteria could apply

Locations (2)

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Number of adverse events (AEs)

Time frame: Approximately 72 weeks

Number of serious adverse events (SAEs)

Time frame: Approximately 72 weeks

Secondary Outcomes

Number of participants who discontinue therapy due to an AE

Time frame: Approximately 72 weeks

Effectiveness of daclatasvir DCV-based therapy

As measured by Sustained virologic response 12 weeks after the end of treatment (SVR12) Achieved SVR12: Hepatitis C virus (HCV) RNA below the lower limit of quantification (LLOQ)

Time frame: Approximately 72 weeks

Data from ClinicalTrials.gov

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