Clinical trial · Observational
Long-term Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Treatment
Long-term Hepatic and Extra-hepatic Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Interferon-free Treatment (LONGHEAD Study)
NCT03042520CI-TRIAL-00054387LONGHEADunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cryoglobulinemia | — | UNRESOLVED | — |
| Diabetes Mellitus | — | UNRESOLVED | — |
| HepatoCellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Fibroses | — | UNRESOLVED | — |
| Metabolic Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation only | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- IFN-based therapy historical controls
- description
- 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,
- interventionNames
- Other: Observation only
- label
- Sofosbuvir-based therapy observational group
- description
- 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.
- interventionNames
- Other: Observation only
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHuang 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 40205145