Long-term Study on Anti-HBV Effect of Tenofovir and Resistance Surveillance in Asian-American Adult Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01267162
• Date of registration: 23/12/2010
• Primary sponsor: Medical Procare PLLC
• Public title: Long-term Study on Anti-HBV Effect of Tenofovir and Resistance Surveillance in Asian-American Adult Patients
• Scientific title: Long-term Observational Study on Anti-HBV Effect of Tenofovir Disoproxil Fumarate (TDF) and Resistance Surveillance in Asian-American Adult Patients Formerly Participating Gilead 123 Studies
• Date of first enrolment: September 2010
• Target sample size: 50
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01267162
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective

Countries of recruitment

United States

Contacts

• Name: Calvin Pan, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female, Asian-American, who have participated and completed the study,
qualify the following criteria, and remain on TDF treatment without severe
treatment-related AEs, and with available retrospective lab results as summarized in
Appendix 2.

- 18 through 75 years of age, inclusive

- Willing to participate in the present study and able to provide written informed
consent

- Continuation of HBV treatment is 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 (i.e., TDF treatment week 48 lab tests by the 123 study)

- 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)

Exclusion Criteria:

- 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.

- Willing and able to provide written informed consent

- Decompensated liver disease defined as direct (conjugated) bilirubin = 1.2 ULN; PT =
1.2 ULN, platelets = 150,000/mm3, or serum albumin = 3.5 g/dL

- Prior history of clinical hepatic decompensation (e.g., ascites, jaundice,
encephalopathy) or variceal hemorrhage

- Serum a-fetoprotein = 50 ng/mL

- Evidence of hepatocellular carcinoma (HCC)

- Co-infection with HIV, HCV, or HDV

- History of significant renal disease (e.g., nephrotic syndrome, renal dysgenesis,
polycystic kidney disease, congenital nephrosis, acute tubular necrosis, other renal
disease)

- History of significant bone disease (e.g., osteomalacia, chronic osteomyelitis,
osteogenesis imperfecta, osteochondroses, multiple bone fractures)

- Significant cardiovascular, pulmonary or neurological disease

- Evidence of a gastrointestinal malabsorption syndrome that may interfere with
absorption of orally administered medications

- History of solid organ or bone marrow transplantation

- Ongoing therapy with any of the following: Nephrotoxic agents

- Parenteral aminoglycoside antibiotics (e.g., gentamicin, tobramycin, amikacin)

- Cidofovir

- Cisplatin

- Foscarnet

- IV amphotericin B

- IV pentamidine

- Oral or IV ganciclovir

- Cyclosporine

- Tacrolimus

- IV vancomycin

- Chronic daily non-steroidal anti-inflammatory drug therapy

- Competitors of renal excretion (e.g., probenecid) Systemic chemotherapeutic agents

- Systemic corticosteroids

- Interleukin-2 (IL-2) and other immunomodulating agents

Investigational agents (except with the expressed approval of the lead investigators)
Administration of any of the above medications must be discontinued at least 30 days prior
to the Baseline Visit and for the duration of the study period.

- Known hypersensitivity to the study drugs, the metabolites or formulation excipients

- Any other condition (including alcohol or substance abuse) or prior therapy that, in
the opinion of the Investigators, would make the subject unsuitable for the study or
unable to comply with dosing requirements



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Hepatitis B

Secondary ID(s)

IN-US-174-0156

Source(s) of Monetary Support

Please refer to primary and secondary sponsors