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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03042520
Other study ID # irb20160082
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 2016
Est. completion date September 2022

Study information

Verified date October 2021
Source Kaohsiung Medical University Chung-Ho Memorial Hospital
Contact Wan-Long Chuang
Phone 0975-356064
Email waloch@kmu.edu.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Primary Endpoint: To evaluate the long-term event-free effect after sofosbuvir-based therapy, in terms of free of major liver events (including HCC, decompensation with ascites, variceal bleeding, hepatic encephalopathy, and liver-related mortality) in CHC patients. Secondary Endpoints: 1. To evaluate hepatic fibrosis progression or regression in CHC patients after sofosbuvir-based therapy. 2. To evaluate the durability of sustained viral response (SVR) in patients achieving SVR after sofosbuvir-based therapy. 3. To evaluate long-term effect of sofosbuvir-based therapy on the extra-hepatic manifestations of the cohort. The items include mixed cryoglobulinemia, chronic kidney diseases, insulin resistance, diabetic status, cardiovascular events and dyslipidemia. 4. To evaluate long-term effect of sofosbuvir-based therapy on quality of life on the cohort. Study Design Prospective, longitudinal observational study Study procedure A total of 200 patients receiving sofosbuvir based direct antiviral agents (DAAs) in the parent studies will be included for following up to 5 years. Their serological, image study and disease status description will be prospectively documented to present the long term effects of sofosbuvir-based therapy. The presentation of illness will be specified as: 1. Main hepatic complications as liver fibrosis, hepatic malignancy, liver decompensation with ascites, hepatic encephalopathy and variceal bleeding, and liver-related mortality. 2. Life quality, extrahepatic symptoms as cryoglobulinemia, diabetes mellitus, insulin resistance, lipid profiles, renal insufficiency and other non-liver morbidities and malignancy.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date September 2022
Est. primary completion date September 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility Main inclusion criteria: For Sofosbuvir-based therapy observational group: - Patients = 20 of years who had ever participated in parent studies, GS-US-337-0131 (NCT02021656) or GS-US-334-0115 (NCT02021643) - Patients who had received at least one dose of sofosbuvir-based therapy in the parent studies. Who IFN-based therapy historical controls, matched with sex, age, level of liver fibrosis and virological response: - Patients = 20 of years who had received pegylated interferon plus ribavirin therapy with match of sex, age, level of liver fibrosis and virological response - Patients who have ever participated study will be collected as historical control. Main exclusion criteria: - Patients not qualified by the main inclusion criteria were excluded. For Sofosbuvir-based therapy observational group: - Patients < 20 of years - Patients who are unwilling to participate the current study - Patients who had never participated in parent studies, GS-US-337-0131 (NCT02021656) nor GS-US-334-0115 (NCT02021643) - Patients who had never received at least one dose of sofosbuvir-based therapy in the parent studies. Who IFN-based therapy historical controls: - Patients < 20 of years - Patients who are unwilling to participate the current study - Patients who had never received pegylated interferon plus ribavirin therapy - Patients who did not participate study

Study Design


Intervention

Other:
Observation only


Locations

Country Name City State
Korea, Republic of Korea University Ansan Hospital Ansan
Korea, Republic of Asan Medical Center Asan
Korea, Republic of Soon Chun Hyang University Hospital Bucheon. Bucheon
Korea, Republic of Dong-A University Hospital Busan
Korea, Republic of Inje University Busan Paik Hospital Busan
Korea, Republic of Kyungpook National University Hospital Daegu
Korea, Republic of Gachon University Gil Hospital Incheon
Korea, Republic of Pusan National University Hospital Pusan
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Korea University Guro Hospital Seoul
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Seoul National University Bundang Hosptial Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul St. Mary's Hospital Seoul
Korea, Republic of Severance Hospital Seoul
Taiwan Changhua Christian Hospital Changhua
Taiwan Kaohsiung Chang Gung Memorial Hospital Kaohsiung
Taiwan Kaoshiung Medical University Hospital Kaohsiung City
Taiwan Keelung Chang Gung Memorial Hospital Keelung
Taiwan China Medical University Taichung
Taiwan Chi Mei Liouying Hospital Tainan
Taiwan MacKay Memorial Hospital Taipei
Taiwan National Cheng Kung University Hospital Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Taipei Veterans General Hospital Taipei
Taiwan Linkou Chang Gung Memorial Hospital Taoyuan

Sponsors (24)

Lead Sponsor Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital Asan Medical Center, Chang Gung Memorial Hospital, Changhua Christian Hospital, Chi Mei Medical Hospital, China Medical University, China, Dong-A University Hospital, Gachon University Gil Medical Center, Gangnam Severance Hospital, Inje University, Korea University, Korea University Guro Hospital, Kyungpook National University Hospital, Mackay Memorial Hospital, National Cheng-Kung University Hospital, National Taiwan University Hospital, Pusan National University Hospital, Samsung Medical Center, Seoul National University Bundang Hospital, Seoul National University Hospital, Seoul St. Mary's Hospital, Severance Hospital, Soon Chun Hyang University, Taipei Veterans General Hospital, Taiwan

Countries where clinical trial is conducted

Korea, Republic of,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants with liver-related morbidity development during 5-year follow-up period after sofosbuvir-based treatment Number of participants with liver-related morbidity during 5-year follow-up period after sofosbuvir-based treatment, including liver fibrosis progression and decompensation 6 years
Primary Number of participants with liver-related mortality development during 5-year follow-up period after sofosbuvir-based treatment Number of participants with liver-related mortality assessed by death due to HCC and/or liver decompensation 6 years
Primary Number of participants with hepatocellular carcinoma (HCC) development during 5-year follow-up period after sofosbuvir-based treatment Number of participants with HCC assessed by histocytology or positive dynamic image plus alpha fetoprotein (AFP) > 400 ng/ml 6 years
Secondary Life quality The change of short form(SF)-36 from baseline 6 years
Secondary Cryoglobulinemia Change of proportion of participants with cryoglobulinemia from baseline cryoglobulinemia from baseline) 6 years
Secondary Diabetes mellitus (DM) Number of participants without DM develop DM assessed by Ac sugar > 126 g/ml 6 years
Secondary Insulin resistance Change of homeostatic model assessment (HOMA-IR), assessed by Glucose x insulin/22.5 from baseline 6 years
Secondary Lipid profiles Change of the serum profile of lipids including triglyceride(TG), cholesterol(Chol), low-density lipoprotein-cholesterol (LDL-C), high-density lipoprotein-cholesterol (HDL-C) from baseline 6 years
Secondary Renal disease the change of the estimated glomerular filtration rate (eGFR) from baseline 6 years
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