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

NCT01715987 | Terminated

• 1 other identifier: BMS AI463-254
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hepatitis B

Keywords

Hepatitis B; Antiviral; Tubular dysfunction; Entecavir; Tenofovir

Outcome Measures

Primary Outcomes (1)

• renal tubular dysfunction

  renal tubular dysfunction as determined by (1) 24 hours Urine phosphate (wasting is \>1200 mg daily); (2) 24 hours β2-microglobulinuria (NL β2-microglobulin level, \<1 mg daily); (3) fractional excretion of uric acid, and (4) fractional tubular reabsorption of phosphorus.

  at 144 week after treatment with antiviral

Study Arms (2)

Tenofovir Disoproxil Fumarate

Patients who are taking Tenofovir Disoproxil Fumarate.

Drug: Tenofovir Disoproxil Fumarate

Entecavir

Patients who are taking Entecavir.

Drug: Entecavir

Interventions

Tenofovir Disoproxil Fumarate DRUG

300mg, oral daily for two years

Also known as: Viread

Tenofovir Disoproxil Fumarate

Entecavir DRUG

0.5mg oral daily for two years.

Also known as: Baraclude

Entecavir

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Asian Americans with hepatitis B taking Entecavir or Tenofovir.

You may qualify if:

• 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.

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

Sponsors & Collaborators

• New Discovery LLC: lead

Study Sites (2)

Asian Pacific Liver Center at St. Vincent Medical Center

Los Angeles, California, 90057, United States

Location

New Discovery LLC

New York, New York, 11355, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Urine

MeSH Terms

Conditions

Hepatitis B

Interventions

Tenofovir; entecavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Calvin Q Pan, M.D.

  Mount Sinai School of Medicine, New York

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2012
• First Posted: October 29, 2012
• Study Start: October 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 6, 2017

Record last verified: 2015-06

Locations

US (2)