Hepatitis B Clinical Trial
Official title:
Real-life Data of Switching From Tenofovir Disoproxi Fumarate (TDF) to Tenofovir Alafenamide (TAF) in Virologically Suppressed Chronic Hepatitis B Patients With Antiviral Resistance
Verified date | June 2018 |
Source | Yonsei University |
Contact | Mi Young Jeon |
Phone | +82-10-8028-2456 |
hyuk4385[@]yuhs.ac | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
- To evaluate the efficacy of switching to tenofovir alafenamide (TAF) 25 mg QD versus
continued tenofovir disoproxil fumarate (TDF) 300 mg QD in CHB patients with antiviral
resistance, as determined by the proportion of virologically suppressed patients at week
48
- To evaluate the safety and tolerability of switching to TAF 25 mg QD versus continuing
TDF 300 mg QD in antiviral-resistant subjects with chronic HBV at week 48
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | August 31, 2020 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures - Adult male and non-pregnant, non-lactating female subjects, =20 years of age based on the date of the screening visit. - Documented evidence of chronic HBV infection previously - TDF monotherapy, TDF-based combination therapy, or switching to TAF at least 4 weeks prior to screening in virologically suppressed chronic hepatitis B patients with multi-antiviral resistance - Must be willing and able to comply with all study requirements Exclusion Criteria: • Co-infection with HCV, HDV, HIV |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Yonsei University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum HBV DNA level | The proportion of subjects who achieve a sustained serum HBV DNA level < 20 IU/mL (undetectable serum HBV DNA by PCR) | at week 48 | |
Secondary | Serum HBV DNA level | The proportion of subjects who achieve a sustained serum HBV DNA level < 20 IU/mL (undetectable serum HBV DNA by PCR) | at week 96 | |
Secondary | Hip and spine BMD | The percent change in hip and spine BMD from baseline | at 48, 96 week | |
Secondary | Serum eGFR | The change in serum eGFR (Cockcroft-Gault method) from baseline | at 24, 48, 72, and 96 week | |
Secondary | Serum creatinine & PO4 level | The change in serum creatinine & PO4 from baseline | at 24, 48, 72, and 96 week |
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