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

NCT03500562 | Terminated

• 1 other identifier: AI444-396
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (2)

• Number of adverse events (AEs)

  Approximately 72 weeks

• Number of serious adverse events (SAEs)

  Approximately 72 weeks

Secondary Outcomes (2)

• Number of participants who discontinue therapy due to an AE

  Approximately 72 weeks

• Effectiveness of daclatasvir DCV-based therapy

  Approximately 72 weeks

Study Arms (1)

HCV participant population in China

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients who receive branded DCV-based therapy in the real-world treatment setting for the first time under the approved indications.

You may qualify if:

• 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

You may not qualify if:

• Participants under the age of 18

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution

Beijing, Beijing Municipality, 100054, China

Location

Local Institution

Guangzhou, Guangdong, 510515, China

Location

Related Links

• BMS Clinical Trial Information
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: April 10, 2018
• First Posted: April 18, 2018
• Study Start: May 8, 2018
• Primary Completion: March 29, 2019
• Study Completion: March 29, 2019
• Last Updated: September 1, 2021

Record last verified: 2021-08

Locations

CN (2)