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Trial record 108 of 340 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

Change of Renal Function and Bone Mineral Density in CHB Patients Switch From TDF to TAF vs. Maintaining TDF (SWITAF)

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ClinicalTrials.gov Identifier: NCT03356834
Recruitment Status : Recruiting
First Posted : November 29, 2017
Last Update Posted : February 2, 2018
Sponsor:
Information provided by (Responsible Party):
George Lau, Humanity and Health Research Centre

Brief Summary:
In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs), majority of these CHB patients experienced drug resistance and switched to Tenofovir disoproxil fumaratate(TDF). However, some of patients on long term TDF experienced impairment of renal function and bone mineral density. After Tenofovir alafenamide(TAF) was in clinical practice, these group of patients got an clinical option to switch from TDF to TAF. The investigators designed a prospective cohort study to evaluate the real life effectiveness and safety in participants with chronic HBV infection switch from TDF to TAF vs. maintaining on TDF.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Tenofovir alafenamide(TAF) Drug: Tenofovir disoproxil fumarate(TDF) Phase 4

Detailed Description:
Tenofovir disoproxil fumarate(TDF) have been associated with renal toxicity and reduced bone mineral density. Tenofovir alafenamide(TAF) is a novel tenofovir prodrug that reduces tenofovir plasma concentrations by 90%, thereby decreasing off-target side-effects. The investigators aimed to assess whether efficacy, safety, and tolerability were non-inferior in participants switched to TAF versus in those remaining on TDF. This is a prospective clinical study.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching From TDF to TAF vs. Maintaining TDF
Actual Study Start Date : December 1, 2017
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2023


Arm Intervention/treatment
Experimental: TDF switch to TAF
Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Tenofovir Alafenamide(TAF) 25mg daily
Drug: Tenofovir alafenamide(TAF)
25 mg tablet administered orally once daily
Other Name: VEMLIDY®
Active Comparator: Maintaining on TDF
Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily
Drug: Tenofovir disoproxil fumarate(TDF)
300 mg tablet administered orally once daily
Other Name: VIREAD®



Primary Outcome Measures :
  1. Antiviral response of TAF [ Time Frame: 60 months ]
    Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients


Secondary Outcome Measures :
  1. Improvement of renal function and bone mineral density in CHB patients switching to TAF [ Time Frame: 60 months ]
    Change of renal function and bone mineral density from baseline in CHB patients of TAF a group compared with TDF group



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chronic hepatitis B,
  2. Antiviral experienced,
  3. Currently on long term TDF anti-HBV treatment,
  4. HBV DNA < 6 log IU/ml (LLOD)
  5. Able to sign the consent form of anticipating in the study

Exclusion Criteria:

  1. Co-infected with HCV, HIV or other viral hepatitis,
  2. Diagnosis of HCC

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 ClinicalTrials.gov identifier (NCT number): NCT03356834


Contacts
Contact: Cheng Wang, M.D. PhD 21539831 wangcheng@hnhmgl.com
Contact: Yudong Wang, PhD 21539831 dannywang@hnhmgl.com

Locations
Hong Kong
Humanity and Health GI and Liver Centre Recruiting
Hong Kong, Hong Kong, 00852
Contact: George KK Lau, MD    (852)28613777    gkklau@netvigator.com   
Contact: Cheng Wang, M.D, PhD    21539831    wangcheng@hnhmgl.com   
Principal Investigator: George KK Lau, MD         
Sponsors and Collaborators
Humanity and Health Research Centre

Responsible Party: George Lau, Humanity & Healthy Medical Group President, Humanity and Health Research Centre
ClinicalTrials.gov Identifier: NCT03356834     History of Changes
Other Study ID Numbers: HumanityHGLC
First Posted: November 29, 2017    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by George Lau, Humanity and Health Research Centre:
Chronic hepatitis B
Efficacy, safety, and tolerability
Tenofovir alafenamide

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
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