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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03366610
• Collaborator: (none)
• Enrollment: 199
• Location: 1
• Actual Duration (Months): 24
• Patients Per Site Per Month: 8.3

Study Details

Study Description

Brief 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)

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C	Other: Non-interventional

Study Design

• Study Type: Observational
• Actual Enrollment: 199 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Apr 28, 2017
• Actual Primary Completion Date: Apr 30, 2019
• Actual Study Completion Date: Apr 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Patients Previously Treated with Daclatasvir-Based Regimens Patients in China Previously Treated with Daclatasvir-Based Regimens	Other: Non-interventional; Non-interventional

Outcome Measures

Primary Outcome Measures

1. Incidence of hepatic disease progression events [up to 5 years]

Secondary Outcome Measures

1. Durability of virologic response [up to 5 years]

   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

2. Change in liver stiffness [baseline up to 5 years]

   measured using elastography values

3. Number of subjects with HCV sequence variants [baseline up to 5 years]

   presence of HCV sequence variants over time in subjects who failed to prior Daclatasvir(DCV)-based therapy

4. Distribution of HCV retreatment patterns [baseline up to 5 years]

   distribution of HCV retreatment patterns including number of subjects receiving retreatment, retreatment regimen, retreatment duration and retreatment results

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Local Institution	Beijing	Beijing	China

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT03366610
• Other Study ID Numbers: AI444-412
• First Posted: Dec 8, 2017
• Last Update Posted: Jun 18, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: Yes
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis

Study Results

No Results Posted as of Jun 18, 2020