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Trial record 59 of 348 for:    hepatitis b | Open Studies

TAF Switch Study in Hepatitis B Monoinfection

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2016 by Asian Pacific Liver Center at St. Vincent Medical Center
Sponsor:
Information provided by (Responsible Party):
Ho Bae, Asian Pacific Liver Center at St. Vincent Medical Center
ClinicalTrials.gov Identifier:
NCT02957994
First received: October 24, 2016
Last updated: November 4, 2016
Last verified: November 2016
  Purpose
To evaluate various markers of renal function and bone density after the switch to Tenofovir alafenamide fumarate (TAF) in chronic hepatitis B patients who are currently treated with Tenofovir disoproxil fumarate (TDF) .

Condition Intervention Phase
Hepatitis B
Drug: Tenofovir alafenamide fumarate
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Analysis of Proximal Renal Tubular Function of "Real World" Chronic Hepatitis B (CHB) Patients Who Are Suppressed on TDF and Switched to TAF

Resource links provided by NLM:


Further study details as provided by Asian Pacific Liver Center at St. Vincent Medical Center:

Primary Outcome Measures:
  • measure renal function after switch to TAF [ Time Frame: one year ] [ Designated as safety issue: No ]
    Kidney function will be measured by blood and urine to compare abnormal results before and after switching to TAF.

  • measure bone density after switch to TAF [ Time Frame: one year ] [ Designated as safety issue: No ]
    Bone density will also be measured to compare T score and Z score before and after switching to TAF


Estimated Enrollment: 80
Study Start Date: November 2016
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TAF Arm
Tenofovir alafenamide fumarate 25mg, 1 tablet once daily for 24 weeks
Drug: Tenofovir alafenamide fumarate
Patients on TDF will be switched to TAF
Other Name: TAF

Detailed Description:

The investigators have previously reported the prevalence of abnormal renal tubular reabsorption of phosphate among CHB patients treated with more than 18 months of TDF to be 48%. Renal tubular dysfunction associated with TDF may be reversible when TDF is discontinued 4. Recently, TAF 25 mg daily was shown to have comparable efficacy to TDF 300 mg with respect to viral suppression in both HBeAg positive and HBeAg negative CHB patients (studies 110 and 108) at 48 weeks of therapy. As speculated, the systemic exposure to tenofovir was significantly less in patients exposed to TAF compared to those on TDF with strikingly less effects noted in a variety of renal and bone parameters for individuals receiving TAF. Notably, however, the question remains to what if any improvements may be seen in CHB patients switched from TDF to TAF.

The investigators propose a prospective open label study to evaluate various markers of renal function and bone density in 80 CHB patients who are currently treated with TDF who are switched to TAF.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with chronic hepatitis B (who are either HBeAg reactive or non-reactive)
  • Treated with TDF with unquantifiable Hepatitis B Virus (HBV) DNA by a sensitive Polymerase chain reaction (PCR) assay for a minimum of 6 months
  • No prior nucleos(t)ide exposure prior to treatment with TDF
  • Treatment with TDF for a minimum of 12 months

Exclusion Criteria:

  • HIV Infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Ho Bae, Medical Director, Asian Pacific Liver Center at St. Vincent Medical Center
ClinicalTrials.gov Identifier: NCT02957994     History of Changes
Other Study ID Numbers: IN-US-320-4200 
Study First Received: October 24, 2016
Last Updated: November 4, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Tenofovir
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

ClinicalTrials.gov processed this record on December 09, 2016