NCT03042520

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

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2016

Longer than P75 for all trials

Geographic Reach
2 countries

26 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 21, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 3, 2017

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

6.1 years

First QC Date

December 21, 2016

Last Update Submit

October 10, 2021

Conditions

Liver FibrosesHepatoCellular CarcinomaCryoglobulinemiaMetabolic DiseaseDiabetes Mellitus

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (6)

  • Life quality

    6 years

  • Cryoglobulinemia

    6 years

  • Diabetes mellitus (DM)

    6 years

  • Insulin resistance

    6 years

  • Lipid profiles

    6 years

  • +1 more secondary outcomes

Study Arms (2)

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,

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.

Other: Observation only

Interventions

Observation onlyOTHER
IFN-based therapy historical controlsSofosbuvir-based therapy observational group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (26)

Korea University Ansan Hospital

Ansan, South Korea

RECRUITING

Asan Medical Center

Asan, South Korea

RECRUITING

Soon Chun Hyang University Hospital Bucheon.

Bucheon-si, South Korea

RECRUITING

Dong-A University Hospital

Busan, South Korea

RECRUITING

Inje University Busan Paik Hospital

Busan, South Korea

RECRUITING

Kyungpook National University Hospital

Daegu, South Korea

RECRUITING

Gachon University Gil Hospital

Incheon, South Korea

RECRUITING

Pusan National University Hospital

Pusan, South Korea

RECRUITING

Gangnam Severance Hospital

Seoul, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Bundang Hosptial

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Seoul St. Mary's Hospital

Seoul, South Korea

RECRUITING

Severance Hospital

Seoul, South Korea

RECRUITING

Changhua Christian Hospital

Changhua, Taiwan

RECRUITING

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

RECRUITING

Kaoshiung Medical University Hospital

Kaohsiung City, Taiwan

RECRUITING

Keelung Chang Gung Memorial Hospital

Keelung, Taiwan

RECRUITING

China Medical University

Taichung, Taiwan

RECRUITING

Chi Mei Liouying Hospital

Tainan, Taiwan

RECRUITING

MacKay Memorial Hospital

Taipei, Taiwan

RECRUITING

National Cheng Kung University Hospital

Taipei, Taiwan

RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

Linkou Chang Gung Memorial Hospital

Taoyuan District, Taiwan

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40205145DERIVED

MeSH Terms

Conditions

Liver CirrhosisCarcinoma, HepatocellularCryoglobulinemiaMetabolic DiseasesDiabetes Mellitus

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesImmunoproliferative DisordersImmune System DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System Diseases

Study Officials

  • Ming-Lung Yu

    Kaoshiung Medical University Hospital

    STUDY DIRECTOR

  • Chia-Yen Dai

    Kaoshiung Medical University Hospital

    PRINCIPAL INVESTIGATOR

  • Jee-Fu Huang

    Kaoshiung Medical University Hospital

    PRINCIPAL INVESTIGATOR

  • Chung-Feng Huang

    Kaoshiung Medical University Hospital

    PRINCIPAL INVESTIGATOR

  • Ming-Lun Yeh

    Kaoshiung Medical University Hospital

    PRINCIPAL INVESTIGATOR

  • Ching-I Huang

    Kaoshiung Medical University Hospital

    PRINCIPAL INVESTIGATOR

  • Ta-Wei Liu

    Kaoshiung Medical University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wan-Long Chuang

CONTACT

0975-356064waloch@kmu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2016

First Posted

February 3, 2017

Study Start

August 1, 2016

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

October 12, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

KR(15)TW(11)