Status:
UNKNOWN
TDF Dose Adjustment VS. Switching to TAF in TDF-experienced CHB Patients With Renal Impairment
Lead Sponsor:
Mahidol University
Conditions:
Renal Insufficiency
Tenofovir
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Tenofovir is a nucleotide analog drug that works against both Human immunodeficiency virus (HIV) and HBV. TDF and TAF are prodrug of Tenofovir. TAF has a higher plasma stability than TDF, which makes ...
Detailed Description
Hepatitis B virus is a global public health problem. More than 250 million people are infected worldwide. These infections lead to chronic hepatitis, cirrhosis and liver cancer. According to past stat...
Eligibility Criteria
Inclusion
- Age between 18 - 75 years old
- Chronic hepatitis B virus infection
- Reduced renal function and need to adjust the dose of TDF
- Have an eGFR of \> 15 ml / min.
- HBV DNA viral load levels \< 10 U/mL in the last 3 months before participating in the project
- No HCC by Ultrasonography of the upper abdomen or CT 3-phase of liver or MRI liver in the 3 months before participating in the project.
Exclusion
- HIV infection or hepatitis C or hepatitis D co-infection
- Decompensated cirrhosis, including variceal bleeding, ascites, hepatic encephalopathy
- Active hepatocellular carcinoma or during the 3 years after treatment
- Solid organ transplantation or Bone marrow transplantation
- Chronic kidney disease caused by glomerulonephritis, tubulo-interstitial nephritis), Obstructive uropathy or autosomal dominant polycystic kidney, and Kidney disease from other causes
- Diabetes with HbA1c\> 8 or uncontrollable hypertension
- Active malignancy of cancer in other organs in the last 3 years
- History of receiving non-steroidal anti-inflammatory drugs (NSAIDs) or other nephrotoxic drugs within the past 1 month (except tenofovir) (For patients receiving NSAIDS after participating in this study, patients were advised to stop taking NSAIDs but not exclude from the study)
- Receive immunosuppressive drug
- Pregnancy
Key Trial Info
Start Date :
November 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04391608
Start Date
November 9 2019
End Date
July 31 2022
Last Update
March 8 2022
Active Locations (1)
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1
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, Thailand, 10700