Long-term Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Treatment

Summary

Primary Objective:

To evaluate the long-term outcomes including liver related morbidity, mortality and hepatocellular carcinoma (HCC) development as compared to those of historical control with interferon(IFN)-based treatment.

Secondary Objective:

1. To access liver fibrosis progression/regression in CHC patients after sofosbuvir-based treatment.
2. To investigate the long-term outcomes of extrahepatic manifestations of the sofosbuvir-based treated cohort as compared to their pretreatment status.

Conditions

• Liver Fibroses
• HepatoCellular Carcinoma
• Cryoglobulinemia
• Metabolic Disease
• Diabetes Mellitus

Interventions

OTHER

Observation only

Sponsors & Collaborators

• Chang Gung Memorial Hospital

  collaborator OTHER

• National Taiwan University Hospital

  collaborator OTHER

• National Cheng-Kung University Hospital

  collaborator OTHER

• Chi Mei Medical Hospital

  collaborator OTHER

• China Medical University, China

  collaborator OTHER

• Mackay Memorial Hospital

  collaborator OTHER

• Taipei Veterans General Hospital, Taiwan

  collaborator OTHER_GOV

• Changhua Christian Hospital

  collaborator OTHER

• Pusan National University Hospital

  collaborator OTHER

• Asan Medical Center

  collaborator OTHER

• Korea University

  collaborator OTHER

• Inje University

  collaborator OTHER

• Korea University Guro Hospital

  collaborator OTHER

• Kyungpook National University Hospital

  collaborator OTHER

• Seoul National University Hospital

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Seoul National University Bundang Hospital

  collaborator OTHER

• Soon Chun Hyang University

  collaborator OTHER

• Seoul St. Mary's Hospital

  collaborator OTHER

• Gachon University Gil Medical Center

  collaborator OTHER

• Dong-A University Hospital

  collaborator OTHER

• Gangnam Severance Hospital

  collaborator OTHER

• Kaohsiung Medical University Chung-Ho Memorial Hospital

  lead OTHER

Principal Investigators

• Ming-Lung Yu · Kaoshiung Medical University Hospital

• Chia-Yen Dai · Kaoshiung Medical University Hospital

• Jee-Fu Huang · Kaoshiung Medical University Hospital

• Chung-Feng Huang · Kaoshiung Medical University Hospital

• Ming-Lun Yeh · Kaoshiung Medical University Hospital

• Ching-I Huang · Kaoshiung Medical University Hospital

• Ta-Wei Liu · Kaoshiung Medical University Hospital

Eligibility

Min Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2022-09-30

Completion

2022-09-30

Countries

• South Korea
• Taiwan

Study Locations