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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01267162
Recruitment Status : Completed
First Posted : December 28, 2010
Last Update Posted : March 16, 2016
Information provided by (Responsible Party):
Medical Procare PLLC

Brief Summary:
This is a Phase IV, open-label, single-arm, 96 week community-based observational study evaluating the antiviral efficacy, safety, and tolerability of TDF in HBV mono-infected Asian-American adults who had completed 48 week treatment with Tenofovir in Gilead 174-0123 study. The primary objective of this study is to evaluate the long-term antiviral efficacy of tenofovir DF 300 mg once daily in these patients. The secondary objectives are to evaluate the safety and tolerability of TDF including the biochemical and virological responses to TDF, the incidence of drug resistance mutations in these patients The duration of treatment in this study is total of three Years (144 weeks) on TDF.

Condition or disease
Chronic Hepatitis B

Study Type : Observational
Actual Enrollment : 31 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : September 2010
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

TDF Treatment

Primary Outcome Measures :
  1. HBV DNA suppression [ Time Frame: in three years ]
  2. safety use of TDF [ Time Frame: in three years ]
    including elevation of creatine or decrease in GFR, TDF resistance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
adult infected with chronic hepatitis B

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 α-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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01267162

United States, California
Asian Pacific Liver Center of St. Vincent Medical Center
LA, California, United States, 90057
San Jose Gastroenterology
San Jose, California, United States, 95128
United States, New York
Dr. Calvin Pan's Flushing Office
Flushing, Queens, New York, United States, 11355
Dreamworks Endoscopy
Flushing, New York, United States, 11354
United States, Pennsylvania
Xiaoli Ma, PC
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Medical Procare PLLC

Responsible Party: Medical Procare PLLC Identifier: NCT01267162     History of Changes
Other Study ID Numbers: IN-US-174-0156
First Posted: December 28, 2010    Key Record Dates
Last Update Posted: March 16, 2016
Last Verified: March 2016

Keywords provided by Medical Procare PLLC:

Additional relevant MeSH terms:
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents