Study to Assess Clinical Outcomes in Chronic Hepatitis C Patients Previously Treated With Daclatasvir-Based Regimens

Hepatitis C Clinical Trial

Official title:

A Long Term Off-treatment Follow-Up Study to Assess Clinical Outcomes in Chronic Hepatitis C Patients in China Previously Treated With Daclatasvir-Based Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03366610
• Other study ID #: AI444-412
• Status: Completed
• Start date: April 28, 2017
• Est. completion date: April 30, 2019

Study information

• Verified date: June 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to assess long-term outcomes in subjects previously treated with daclatasvir-based therapy for chronic Hepatitis-C (CHC)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: April 30, 2019
• Est. primary completion date: April 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males or females 18 years of age or older at initiation of prior DCV-based therapy

• Previously treated with DCV (manufactured by BMS)-based therapy in combination with other HCV direct acting antivirals (DAAs) for at least 8 weeks

• Must enroll in this study within 12 months of end of treatment of DCV-based therapy or within 6 months of protocol availability at the clinical site for subjects treated in the AI447036 or AI447114 studies

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Other:
• Non-interventional
Non-interventional

Locations

Country	Name	City	State
China	Local Institution	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hepatic disease progression events		up to 5 years
Secondary	Durability of virologic response	assessed by response in subjects previously treated with DCV-based therapy who achieved sustained virologic response at 12 or 24 weeks(SVR12/24) after the end of treatment	up to 5 years
Secondary	Change in liver stiffness	measured using elastography values	baseline up to 5 years
Secondary	Number of subjects with HCV sequence variants	presence of HCV sequence variants over time in subjects who failed to prior Daclatasvir(DCV)-based therapy	baseline up to 5 years
Secondary	Distribution of HCV retreatment patterns	distribution of HCV retreatment patterns including number of subjects receiving retreatment, retreatment regimen, retreatment duration and retreatment results	baseline up to 5 years

External Links

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