Tubular Function in Asian-American Patients Receiving TDF or ETV for HBV Treatment

Stopped early

Conditions studied: Hepatitis B

In brief

Nucleotide anti-viral analogues, including adefovir and TDF, have demonstrated kidney toxicity in HIV/HBV co-infected patients and HBV mono-infected European patients. Investigators suspected similar kidney proximal tubular injury can also occur in HBV mono infected Asian patients receiving TDF treatment.

Key facts

Study ID

NCT01715987

Run by

New Discovery LLC

People needed

48

Starts

2012-10-01

Expected to finish

2016-05-01

Last updated by the study team

2017-09-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 18-70 year-old Asian-American male or female patients with HBeAg+ or HBeAg-CHB
• On TDF or ETV mono-therapy for 12-24 months, not previously exposed to other oral HBV drugs, nor received any type of interferon treatment in the past 12 months
• Be willing to participate
• Continuation of HBV treatment is medically indicated. That is for HBeAg-positive subjects, HBeAg remain positive or HBeAg becomes negative but still has detectable DNA by the PCR method; and for HBeAg-negative subjects, HBV DNA is either detectable or undetectable by the PCR method
• No clinical or virologic evidence of anti-HBV resistance to TDF treatment at the time of entering tests
• Serum creatinine < 1.5 mg/L and estimated glomerular filtration rate (creatinine clearance) ≥ 60 mL/min/1.73m2 by the Cockcroft-Gault equation:
• (140-age in years)(body weight [kg] )/((72)(serum creatinine [mg/dl]) ) [Note: multiply estimated rate 0. by 85 for women; use actual body weight]
• Adequate hematologic function (absolute neutrophil count ≥ 1,500/mm3; hemoglobin ≥ 10.0 g/dL)
• To assure all the subjects will be regularly followed per study protocol and minimize the drop off rate, the subjects have to have documented pre-treatment full evaluation and necessary blood tests, medical adherence to HBV treatment, and regular follow-up (i.e., on HBV treatment not missing HBV medication (TDF or ETV) for more than a week, with medical follow-up for HBV treatment at least every 6 month and had all the necessary labs performed.
• In the absence of exclusion criteria.

You may not qualify if…

• Ethnicity: Non-Asian CHB patients
• Age: >70 years old
• Body weight and height: BMI ≥ 30
• Concomitant nephrotoxic agents - record all prescription and nonprescription items including herbs and natural remedies, NSAIDs, acyclovir, statins, ACEI or ARBs, Valproate
• Any other antiretroviral meds, antibiotic exposure during study to be noted
• History of HCV, HDV, or HIV co-infection
• Prior history of clinical hepatic decompensation defined as direct (conjugated) bilirubin ≥ 1.2 ULN; PT ≥ 1.2 ULN, platelets ≤ 50,000/mm3, or serum albumin ≤ 3.5 g/dL, ascites, jaundice, encephalopathy, or variceal hemorrhage
• Serum α-fetoprotein ≥ 50 ng/mL
• Evidence of hepatocellular carcinoma (HCC)
• History of solid organ or bone marrow transplantation
• History of malignancies in the past 5 years
• Pregnant women, and women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
• Males and females of reproductive potential who are not willing to use an effective method of contraception during the study. For males, condoms should be used and for females, a barrier contraception method should be used in combination with one other form of contraception.
• History of significant renal disease
• History of significant bone disease
• History of HTN or DM on medical treatment
• Ongoing therapy with any of the following:
• Nephrotoxic agents
• Parenteral aminoglycoside antibiotics
• Cidofovir
• Cisplatin
• Foscarnet
• IV amphotericin B
• IV pentamidine
• Oral or IV ganciclovir

Where it is running

• Asian Pacific Liver Center at St. Vincent Medical Center — Los Angeles, California, United States
• New Discovery LLC — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.