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

Daclatasvir-Based Therapy Safety Surveillance in Chinese Patients With Chronic Hepatitis C

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03500562

Enrollment

Registered

2018-04-18

Start date

2018-05-08

Completion date

2019-03-29

Last updated

2021-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Number of adverse events (AEs)	Approximately 72 weeks
Number of serious adverse events (SAEs)	Approximately 72 weeks

Secondary

Measure	Time frame	Description
Number of participants who discontinue therapy due to an AE	Approximately 72 weeks	—
Effectiveness of daclatasvir DCV-based therapy	Approximately 72 weeks	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)

Countries

China

Outcome results