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Trial record 77 of 82 for:    GRAZOPREVIR ANHYDROUS AND ELBASVIR

eGFR Evolution in HCV Patients Receiving SOF-based or SOF-free DAAs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04047680
Recruitment Status : Completed
First Posted : August 7, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date August 5, 2019
First Posted Date August 7, 2019
Last Update Posted Date August 8, 2019
Actual Study Start Date February 2015
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 5, 2019)
Slope differences of eGFR [ Time Frame: Baseline to off-therapy week 24 ]
Slope differences of eGFR between SOF-based and SOF-free DAAs
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT04047680 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title eGFR Evolution in HCV Patients Receiving SOF-based or SOF-free DAAs
Official Title Evolution of Estimated Glomerular Filtration Rate in Chronic Hepatitis C Patients Receiving Sofosbuvir-based or Sofosbuvir-free Direct Acting Antivirals
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).
Detailed Description

Chronic hepatitis C virus (HCV) infection is a major health problem that affects 71 million people worldwide. Patients with chronic HCV infection may present with various hepatic and extrahepatic manifestations which lead to substantial morbidity and mortality. In contrast, the long-term health outcome improves following successful HCV eradication by antiviral therapies.

Owing to the excellent efficacy and safety as well as the short treatment duration, the use of interferon (IFN)-free direct acting antivirals (DAAs) has become the standard-of-care for managing HCV. Sofosbuvir (SOF) is a pyrimidine nucleotide analogue which acts as the HCV ribonucleic acid (RNA) chain terminator by inhibiting HCV non-structural protein 5B (NS5B) RNA-dependent RNA polymerase following intrahepatic activation to uridine triphosphate form. Dephosphorylation results in the formation of inactive metabolite (GS-331007) that undergoes extensive renal excretion. Clinically, SOF is administered once-daily with pangenotypic potency, well tolerability and a high genetic barrier to drug resistance. Furthermore, SOF can be used in combination with NS3/4A protease inhibitors (PIs), NS5A inhibitors, and/or ribavirin (RBV) to achieve high rates of sustained virologic response (SVR). Therefore, applying SOF-based DAAs for HCV is welcome to most treating physicians.

Following the widespread use of SOF-based DAAs for treating HCV in different populations, a large-scale real-world HCV-TARGET study enrolling 1,789 patients indicated that patients with a baseline eGFR ≤ 45 mL/min/1.73m2 were associated with a higher risk of worsening renal function than those with a baseline eGFR > 45 mL/min/1.73m2 following SOF-based DAAs. Moreover, three retrospective studies showed that SOF-based DAAs negatively affected the on-treatment and off-therapy eGFR. On the contrary, other studies showed that the use of SOF-based DAAs did not worsen the eGFR. Because most studies were retrospective in nature without protocol-defined time point for eGFR assessment or patient election, and did not enroll patients receiving SOF-free DAAs as the controls, the investigators thus conducted a prospective study to evaluate the evolution of eGFR in patients with chronic HCV infection receiving SOF-based or SOF-free DAAs.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-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
Condition
  • Hepatitis C
  • Renal Disease
  • Viral Hepatitis C
Intervention
  • Drug: Sofosbuvir / Velpatasvir Oral Tablet
    Sofosbuvir/velpatasvir for 12 weeks
    Other Name: Epclusa
  • Drug: Sofosbuvir and Ledipasvir
    Sofosbuvir and ledipasvir for 12 weeks
    Other Name: Harvoni
  • Drug: Sofosbuvir Tablets
    Sofosbuvir plus ribavirin (RBV) or daclatasvir (DCV) for 12 weeks
    Other Name: Solvadi
  • Drug: Ombitasvir/paritaprevir/ritonavir
    Ombitasvir/paritaprevir/ritonavir for 12 weeks
    Other Name: Viekirax/exviera
  • Drug: Elbasvir / Grazoprevir Oral Tablet
    Elbasvir/grazoprevir for 12 weeks
    Other Name: Zepatier
  • Drug: Glecaprevir and Pibrentasvir
    Glecaprevir/pibrentasvir for 12 weeks
    Other Name: Maviret
Study Groups/Cohorts
  • SOF-based DAAs
    Patients receiving sofosbuvir (SOF)-based direct acting antiviral agents (DAAs) for 12 weeks
    Interventions:
    • Drug: Sofosbuvir / Velpatasvir Oral Tablet
    • Drug: Sofosbuvir and Ledipasvir
    • Drug: Sofosbuvir Tablets
  • SOF-free DAAs
    Patients receiving sofosbuvir (SOF)-free direct acting antiviral agents (DAAs) for 12 weeks
    Interventions:
    • Drug: Ombitasvir/paritaprevir/ritonavir
    • Drug: Elbasvir / Grazoprevir Oral Tablet
    • Drug: Glecaprevir and Pibrentasvir
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 5, 2019)
441
Original Actual Enrollment Same as current
Actual Study Completion Date June 2019
Actual Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04047680
Other Study ID Numbers 201509009RINB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators
Study Director: Jia-Horng Kao, PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date August 2019