Treatment Efficacy and Safety of TDF-TAF Switch Study in South Korea

NCT03559790 | Unknown FDA Drug

• 1 other identifier: Gilead IN-US-320-4407
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Recent TAF has introduced to have more safe profiles than TDF in clinical trials. Especially, TDF has the renal safety issue in high risk group including HIV, decompensated cirrhosis (ascites), uncontrolled DM etc. However, there is no available cohort data for treatment efficacy and safety in TDF-TAF switch therapy in treatment-naïve chronic hepatitis B. The aim of this study is to evaluate safety and efficacy of TAF switch therapy in patients with chronic hepatitis B who have been treated with TDF.

Conditions

Chronic Hepatitis b

Keywords

chronic hepatitis B; tenofovir alafenamide; tenofovir disoproxil fumarate; Safety; Efficacy

Outcome Measures

Primary Outcomes (3)

• Complete Virological response

  Portion of subjects with plasma HBV DNA levels below 116 copies/mL

  at Week 96.

• Incidence of of elevation of serum creatinine as a measure of renal safety

  Incidence of elevation of serum creatinine (\>0.5mg/dL) from baseline creatinine

  at Week 96

• Incidence of osteopenia and osteoporosis as a measure of bone safety

  Incidence of osteopenia and osteoporosis according to Bone Mineral Density

  at Week 96

Secondary Outcomes (4)

• Biochemical response

  at Week 48 and 96

• Serologic response

  at Week 48 and 96

• Serologic response

  at Week 48 and 96

• Incidence of treatment-emergent adverse events

  at Week 48 and 96

Interventions

tenofovir alafenamide DRUG

To evaluate of efficacy and safety in patients with TDF-TAF switch therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population that receive TDF-TAF switch therapy

You may qualify if:

• Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures.
• Adult male and non-pregnant, non-lactating female subjects, 18 years of age and older, based on the date of the screening visit. A negative serum pregnancy test at Screening is required for female subjects of childbearing potential (unless surgically sterile or greater than 2 years post-menopausal).
• Documented evidence of chronic HBV infection (e.g. HBsAg positive for more than 6 months)
• Previous TDF naïve treatment (more than 96 weeks) baseline status including chronic hepatitis B with the following:
• HBeAg-positive and HBeAb negative at Screening
• Screening HBV DNA ≥ 1x 105 copies/mL
• Screening serum ALT level ≥2×ULN(80 IU/L) and ≤ 10 ×ULN (by center laboratory range) OR
• HBeAg-negative and HBeAb positive at Screening
• Screening HBV DNA ≥ 1x 104 copies/mL
• Screening serum ALT level ≥2×ULN(80 IU/L) and ≤ 10 ×ULN (by center laboratory range) OR
• Cirrhosis at Screening
• Screening HBV DNA ≥ 1x 104 copies/mL regardless of HBeAg status
• Treatment naïve subjects defined as no history of antiviral therapy or \< 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue, including lamivudine or adefovir, clevudine, telbivudine, entecavir
• The decision is made by the provider and patient to switch from TDF to TAF prior to discussion of the study of enrollment
• Following the decision to switch therapy, signed written informed consent after being instructed about the objective and procedure of the clinical study

You may not qualify if:

• Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
• Co-infection with HCV, HIV
• Evidence of hepatocellular carcinoma (e.g. α-fetoprotein\> 50 ng/mL or as evidenced by recent ultrasound or other standard of care measure)
• Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible
• Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
• Currently receiving therapy with cytotoxic agent, nephrotoxic agents, or agents capable of modifying renal excretion
• Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.

Sponsors & Collaborators

• The Catholic University of Korea: lead

Study Sites (1)

The Catholic University of Korea, Daejeon St.Mary's Hosptial

Junggu, Daejeon, South Korea

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

tenofovir alafenamide

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Myeong Jun Song

  Daejeon St. Mary's hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Myeong Jun Song, Ph D

CONTACT

0422209291; mjsong95@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: June 18, 2018
• Study Start: July 18, 2018
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2021
• Last Updated: January 30, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)