NCT04047680

Brief Summary

Data regarding the nephrotoxicity of sofosbuvir (SOF) remain controversial. The investigators compared the changes of estimated glomerular filtration rate (eGFR) in patients with chronic hepatitis C virus (HCV) infection receiving SOF-based or SOF-free direct acting antivirals (DAAs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
441

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

February 1, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2019

Completed
Last Updated

August 8, 2019

Status Verified

August 1, 2019

Enrollment Period

3.8 years

First QC Date

August 5, 2019

Last Update Submit

August 6, 2019

Conditions

Hepatitis CRenal DiseaseViral Hepatitis C

Keywords

Viral hepatitis CGlomerular filtration rateDirect acting antiviral agentSofosbuvir

Outcome Measures

Primary Outcomes (1)

  • Slope differences of eGFR

    Slope differences of eGFR between SOF-based and SOF-free DAAs

    Baseline to off-therapy week 24

Study Arms (2)

SOF-based DAAs

Patients receiving sofosbuvir (SOF)-based direct acting antiviral agents (DAAs) for 12 weeks

Drug: Sofosbuvir / Velpatasvir Oral TabletDrug: Sofosbuvir and LedipasvirDrug: Sofosbuvir Tablets

SOF-free DAAs

Patients receiving sofosbuvir (SOF)-free direct acting antiviral agents (DAAs) for 12 weeks

Drug: Ombitasvir/paritaprevir/ritonavirDrug: Elbasvir / Grazoprevir Oral TabletDrug: Glecaprevir and Pibrentasvir

Interventions

Sofosbuvir / Velpatasvir Oral TabletDRUG

Sofosbuvir/velpatasvir for 12 weeks

Also known as: Epclusa
SOF-based DAAs
Sofosbuvir and LedipasvirDRUG

Sofosbuvir and ledipasvir for 12 weeks

Also known as: Harvoni
SOF-based DAAs
Sofosbuvir TabletsDRUG

Sofosbuvir plus ribavirin (RBV) or daclatasvir (DCV) for 12 weeks

Also known as: Solvadi
SOF-based DAAs
Ombitasvir/paritaprevir/ritonavirDRUG

Ombitasvir/paritaprevir/ritonavir for 12 weeks

Also known as: Viekirax/exviera
SOF-free DAAs
Elbasvir / Grazoprevir Oral TabletDRUG

Elbasvir/grazoprevir for 12 weeks

Also known as: Zepatier
SOF-free DAAs
Glecaprevir and PibrentasvirDRUG

Glecaprevir/pibrentasvir for 12 weeks

Also known as: Maviret
SOF-free DAAs

Eligibility Criteria

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

Chronic hepatitis C virus-infected patients with compensated liver diseases and baseline eGFR of 30 mL/min/1.73m2 or more, who received SOF-based or SOF-free DAAs for 12 weeks, and who received off-therapy follow-up until week 24

You may qualify if:

  • Chronic HCV patients receiving SOF-based or SOF-free DAAs for 12 weeks

You may not qualify if:

  • Decompensated cirrhosis (Child-Pugh B or C)
  • Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73m2
  • Active hepatocellular carcinoma (HCC)
  • Organ transplantation
  • Hepatitis B virus (HBV) co-infection
  • Human immunodeficiency virus (HIV) co-infection
  • Not received off-therapy follow-up till week 24

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Taiwan University Hospital, Yun-Lin Branch

Douliu, 10002, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Related Publications (1)

  • Liu CH, Lee MH, Lin JW, Liu CJ, Su TH, Tseng TC, Chen PJ, Chen DS, Kao JH. Evolution of eGFR in chronic HCV patients receiving sofosbuvir-based or sofosbuvir-free direct-acting antivirals. J Hepatol. 2020 May;72(5):839-846. doi: 10.1016/j.jhep.2019.11.014. Epub 2019 Nov 29.

    PMID: 31790766DERIVED

MeSH Terms

Conditions

Hepatitis CKidney Diseases

Interventions

sofosbuvir-velpatasvir drug combinationledipasvir, sofosbuvir drug combinationSofosbuvirombitasvirelbasvir-grazoprevir drug combinationglecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotides

Study Officials

  • Jia-Horng Kao, PhD

    National Taiwan University Hospital

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 5, 2019

First Posted

August 7, 2019

Study Start

February 1, 2015

Primary Completion

December 1, 2018

Study Completion

June 1, 2019

Last Updated

August 8, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

TW(2)