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Completed

NCT Number: NCT03366610

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

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

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Local Institution

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional

Other

Non-interventional

Primary outcomes

  1. Incidence of hepatic disease progression events

    Time frame: up to 5 years

Secondary outcomes

  1. Durability of virologic response

    Time frame: 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

    Time frame: baseline up to 5 years

    measured using elastography values

  3. Number of subjects with HCV sequence variants

    Time frame: 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

    Time frame: baseline up to 5 years

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 8, 2017
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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