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

Diabetes Mellitus Clinical Trial

— LONGHEAD  

Official title:

Long-term Hepatic and Extra-hepatic Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Interferon-free Treatment (LONGHEAD Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03042520
• Other study ID #: irb20160082
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Cryoglobulinemia
• Diabetes Mellitus
• Hepatitis C
• Hepatitis C, Chronic
• HepatoCellular Carcinoma
• Liver Cirrhosis
• Liver Fibroses
• Metabolic Disease
• Metabolic Diseases

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