Liver FibrosesLONGHEADNCT03042520
Long-term Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Treatment
An observational study of Liver Fibroses and HepatoCellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 26 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Liver Fibroses, HepatoCellular Carcinoma, Cryoglobulinemia
- What is being tested?
- Observation only
- How many people
- 200 participants
- Where
- 26 sitesin 2 countries
- Study dates
- Aug 2016to Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who had ever participated the parent studies, GS-US-334-0115 or GS-US-337-0131, will be invited to participate the current study in outpatient clinic. For the patients who have participated study will be invited to participate the current study as matched historical control n our outpatient clinic, Written informed consent will be obtained after full explanation to the patients who had ever participated in parent studies, GS-US-337-0131 (NCT02021656) or GS-US-334-0115 (NCT02021643) and had received at least one dose of sofosbuvir-based therapy in the parent studies.
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
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
South Korea15 sites, 15 recruiting
- Recruiting
Korea University Ansan Hospital
Ansan
Hyung Joon Yim
- Recruiting
Asan Medical Center
Asan
Young-Suk Lim
- Recruiting
Soon Chun Hyang University Hospital Bucheon.
Bucheon-si
Young Seok Kim
- Recruiting
Dong-A University Hospital
Busan
Sang-Young Han
- Recruiting
Inje University Busan Paik Hospital
Busan
Youn-Jae Lee
- Recruiting
Kyungpook National University Hospital
Daegu
Won Young Tak
- Recruiting
Gachon University Gil Hospital
Incheon
Ju-Hyun Kim
- Recruiting
Pusan National University Hospital
Pusan
Heo Jeong
- Recruiting
Gangnam Severance Hospital
Seoul
Kwan Sik Lee
- Recruiting
Korea University Guro Hospital
Seoul
Yoon Jun Kim
- Recruiting
Samsung Medical Center
Seoul
Seung Woon Paik
- Recruiting
Seoul National University Bundang Hosptial
Seoul
Sook-Hyang Jeong
- Recruiting
Seoul National University Hospital
Seoul
Kwan Soo Byun
- Recruiting
Seoul St. Mary's Hospital
Seoul
Seung-Kew Yoon
- Recruiting
Severance Hospital
Seoul
Sang Hoon Ahn
Taiwan11 sites, 11 recruiting
- Recruiting
Changhua Christian Hospital
Changhua
Yu-Chun Hsu
- Recruiting
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City
Tsung-Hui Hu
- Recruiting
Kaoshiung Medical University Hospital
Kaohsiung City
Wan-Long Chuang, 0975-356064, waloch@kmu.edu.tw
- Recruiting
Keelung Chang Gung Memorial Hospital
Keelung
Rong-Nan Chien
- Recruiting
China Medical University
Taichung
Cheng-Yuan Peng
- Recruiting
Chi Mei Liouying Hospital
Tainan
Chih-Chou Chen
- Recruiting
MacKay Memorial Hospital
Taipei
Horng-Yuan Wang
- Recruiting
National Cheng Kung University Hospital
Taipei
Ting-Tsung Chang
- Recruiting
National Taiwan University Hospital
Taipei
Jia-Horng Kao
- Recruiting
Taipei Veterans General Hospital
Taipei
Chi-Jen Chu
- Recruiting
Linkou Chang Gung Memorial Hospital
Taoyuan
I-Shyan Sheen
About this study
Official title: Long-term Hepatic and Extra-hepatic Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Interferon-free Treatment (LONGHEAD Study)
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:
- To access liver fibrosis progression/regression in CHC patients after sofosbuvir-based treatment.
- To investigate the long-term outcomes of extrahepatic manifestations of the sofosbuvir-based treated cohort as compared to their pretreatment status.
Read the detailed 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:
- To evaluate hepatic fibrosis progression or regression in CHC patients after sofosbuvir-based therapy.
- To evaluate the durability of sustained viral response (SVR) in patients achieving SVR after sofosbuvir-based therapy.
- 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.
- 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:
- Main hepatic complications as liver fibrosis, hepatic malignancy, liver decompensation with ascites, hepatic encephalopathy and variceal bleeding, and liver-related mortality.
- Life quality, extrahepatic symptoms as cryoglobulinemia, diabetes mellitus, insulin resistance, lipid profiles, renal insufficiency and other non-liver morbidities and malignancy.
- Conditions
- Liver Fibroses, HepatoCellular Carcinoma, Cryoglobulinemia, Metabolic Disease, Diabetes Mellitus
- Being tested
- Observation only
- Medical subject headings
- Liver Cirrhosis, Carcinoma, Hepatocellular, Cryoglobulinemia, Metabolic Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation onlyOther
| Study group | Role | What they receive |
|---|---|---|
| IFN-based therapy historical controls | Patients who had ever participated the parent studies, GS-US-334-0115 or GS-US-337-0131, will be invited to participate the current study in outpatient clinic. For the patients who have participated study will be invited to participate the current study as matched historical control n our outpatient clinic, Receives: Other: Observation only | |
| Sofosbuvir-based therapy observational group | 1. Patients ≥ 20 of years who had ever participated in parent studies, GS-US-337-0131 (NCT02021656) or GS-US-334-0115 (NCT02021643)
2. 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:
1. Patients ≥ 20 of years who had received peginterferon plus ribavirin therapy with match of sex, age, level of liver fibrosis and virological response
2. Patients who have ever participated study will be collected as historical control. Receives: Other: Observation only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 years
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
Measured: 6 years
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
Measured: 6 years
Secondary outcomes (6)
Life quality
The change of short form(SF)-36 from baseline
Measured: 6 years
Cryoglobulinemia
Change of proportion of participants with cryoglobulinemia from baseline cryoglobulinemia from baseline)
Measured: 6 years
Diabetes mellitus (DM)
Number of participants without DM develop DM assessed by Ac sugar > 126 g/ml
Measured: 6 years
Insulin resistance
Change of homeostatic model assessment (HOMA-IR), assessed by Glucose x insulin/22.5 from baseline
Measured: 6 years
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
Measured: 6 years
Renal disease
the change of the estimated glomerular filtration rate (eGFR) from baseline
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2017 (estimated)
- Study startAug 2016
- Primary completionSep 2022 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver FibrosesStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, National Taiwan University Hospital, National Cheng-Kung University Hospital, Chi Mei Medical Hospital, China Medical University, China, Mackay Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Changhua Christian Hospital, Pusan National University Hospital, Asan Medical Center, Korea University, Inje University, Korea University Guro Hospital, Kyungpook National University Hospital, Seoul National University Hospital, Severance Hospital, Samsung Medical Center, Seoul National University Bundang Hospital, Soon Chun Hyang University, Seoul St. Mary's Hospital, Gachon University Gil Medical Center, Dong-A University Hospital, Gangnam Severance Hospital
- Responsible party
- Sponsor
- Investigators
- Ming-Lung Yu, Study director, Kaoshiung Medical University HospitalChia-Yen Dai, Principal investigator, Kaoshiung Medical University HospitalJee-Fu Huang, Principal investigator, Kaoshiung Medical University HospitalChung-Feng Huang, Principal investigator, Kaoshiung Medical University HospitalMing-Lun Yeh, Principal investigator, Kaoshiung Medical University HospitalChing-I Huang, Principal investigator, Kaoshiung Medical University HospitalTa-Wei Liu, Principal investigator, Kaoshiung Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03042520
- Sponsor's protocol ID
- irb20160082
- Acronym
- LONGHEAD
- Status last verified
- Oct 2021
- First submitted
- 21 Dec 2016
- Last updated
- 12 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Huang CF, Heo J, Chien RN, Baek YH, Kao JH, Kim JH, Chang TT, Byun KS, Chen JJ, Jeong SH, Hu TH, Kim YS, Peng CY, Tak WY, Wang HY, Yoon SK, Sheen IS, Youn-Jae Lee, Hsu YC, Yim HJ, Tsai PC, Yeh ML, Ahn SH, Dai CY, Paik SW, Huang JF, Kim YJ, Chuang WL, Lim YS, Yu ML. Long-Term Hepatic and Extrahepatic Outcomes of Chronic Hepatitis C Patients After Sofosbuvir-Based Treatment (LONGHEAD Study). Infect Dis Ther. 2025 May;14(5):1089-1101. doi: 10.1007/s40121-025-01145-y. Epub 2025 Apr 10.
PubMed 40205145
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Hepatic and Extra-hepatic Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Interferon-free Treatment (LONGHEAD Study)
- ClinicalTrials.gov ID
- NCT03042520
- Acronym / sponsor ID
- LONGHEAD / irb20160082
- Conditions
- Liver Fibroses, HepatoCellular Carcinoma, Cryoglobulinemia, Metabolic Disease, Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Chang Gung Memorial Hospital, National Taiwan University Hospital, National Cheng-Kung University Hospital, Chi Mei Medical Hospital, China Medical University, China, Mackay Memorial Hospital, Taipei Veterans General Hospital, Taiwan, Changhua Christian Hospital, Pusan National University Hospital, Asan Medical Center, Korea University, Inje University, Korea University Guro Hospital, Kyungpook National University Hospital, Seoul National University Hospital, Severance Hospital, Samsung Medical Center, Seoul National University Bundang Hospital, Soon Chun Hyang University, Seoul St. Mary's Hospital, Gachon University Gil Medical Center, Dong-A University Hospital, Gangnam Severance Hospital
- Study start
- Aug 2016 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 3 Feb 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To access liver fibrosis progression/regression in CHC patients after sofosbuvir-based treatment.
- To investigate the long-term outcomes of extrahepatic manifestations of the sofosbuvir-based treated cohort as compared to their pretreatment status.
Detailed 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:
- To evaluate hepatic fibrosis progression or regression in CHC patients after sofosbuvir-based therapy.
- To evaluate the durability of sustained viral response (SVR) in patients achieving SVR after sofosbuvir-based therapy.
- 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.
- 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:
- Main hepatic complications as liver fibrosis, hepatic malignancy, liver decompensation with ascites, hepatic encephalopathy and variceal bleeding, and liver-related mortality.
- Life quality, extrahepatic symptoms as cryoglobulinemia, diabetes mellitus, insulin resistance, lipid profiles, renal insufficiency and other non-liver morbidities and malignancy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IFN-based therapy historical controls | – | Other: Observation onlyPatients who had ever participated the parent studies, GS-US-334-0115 or GS-US-337-0131, will be invited to participate the current study in outpatient clinic. For the patients who have participated study will be invited to participate the current study as matched historical control n our outpatient clinic, |
| Sofosbuvir-based therapy observational group | – | Other: Observation only1. Patients ≥ 20 of years who had ever participated in parent studies, GS-US-337-0131 (NCT02021656) or GS-US-334-0115 (NCT02021643) 2. 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: 1. Patients ≥ 20 of years who had received peginterferon plus ribavirin therapy with match of sex, age, level of liver fibrosis and virological response 2. Patients who have ever participated study will be collected as historical control. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had ever participated the parent studies, GS-US-334-0115 or GS-US-337-0131, will be invited to participate the current study in outpatient clinic. For the patients who have participated study will be invited to participate the current study as matched historical control n our outpatient clinic, Written informed consent will be obtained after full explanation to the patients who had ever participated in parent studies, GS-US-337-0131 (NCT02021656) or GS-US-334-0115 (NCT02021643) and had received at least one dose of sofosbuvir-based therapy in the parent studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation only | Other | IFN-based therapy historical controls, Sofosbuvir-based therapy observational group |
Primary outcome
Number of participants with liver-related morbidity development during 5-year follow-up period after sofosbuvir-based treatment
Time frame: 6 years
Number of participants with liver-related morbidity during 5-year follow-up period after sofosbuvir-based treatment, including liver fibrosis progression and decompensation
Number of participants with liver-related mortality development during 5-year follow-up period after sofosbuvir-based treatment
Time frame: 6 years
Number of participants with liver-related mortality assessed by death due to HCC and/or liver decompensation
Number of participants with hepatocellular carcinoma (HCC) development during 5-year follow-up period after sofosbuvir-based treatment
Time frame: 6 years
Number of participants with HCC assessed by histocytology or positive dynamic image plus alpha fetoprotein (AFP) > 400 ng/ml
6 secondary outcomes
Life quality
Time frame: 6 years
Cryoglobulinemia
Time frame: 6 years
Diabetes mellitus (DM)
Time frame: 6 years
Insulin resistance
Time frame: 6 years
Lipid profiles
Time frame: 6 years
Renal disease
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Derived from this study: PubMed 40205145Huang CF, Heo J, Chien RN, Baek YH, Kao JH, Kim JH, Chang TT, Byun KS, Chen JJ, Jeong SH, Hu TH, Kim YS, Peng CY, Tak WY, Wang HY, Yoon SK, Sheen IS, Youn-Jae Lee, Hsu YC, Yim HJ, Tsai PC, Yeh ML, Ahn SH, Dai CY, Paik SW, Huang JF, Kim YJ, Chuang WL, Lim YS, Yu ML. Long-Term Hepatic and Extrahepatic Outcomes of Chronic Hepatitis C Patients After Sofosbuvir-Based Treatment (LONGHEAD Study). Infect Dis Ther. 2025 May;14(5):1089-1101. doi: 10.1007/s40121-025-01145-y. Epub 2025 Apr 10.
- Individual participant dataSharing planned: No
Related trials for Liver Fibroses
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingObservational study
Treatment Outcomes and Predictors After Endovascular Intervention for Portal Hypertension-Related Gastrointestinal Bleeding in Cirrhosis
Cirrhosis, Portal Hypertension Related to Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ming-Lung Yu study director
Kaoshiung Medical University Hospital
Chia-Yen Dai principal investigator
Kaoshiung Medical University Hospital
Jee-Fu Huang principal investigator
Kaoshiung Medical University Hospital
26 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Fibroses and HepatoCellular Carcinoma, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 26 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in South Korea, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan-Long Chuang (0975-356064, waloch@kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with liver-related morbidity development during 5-year follow-up period after sofosbuvir-based treatment (time frame: 6 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03042520, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2021.