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The Impact of Tenofovir Alafenamide on Profiles of Body Weight and Metabolic Features in Chronic Hepatitis B Patients. (HBV)

11 maggio 2021 aggiornato da: National Cheng-Kung University Hospital

The Impact of Tenofovir Alafenamide on Profiles of Body Weight and Metabolic Features in Chronic Hepatitis B Patients

The aim of this study is to compare the BW and metabolic profiles of CHB patient before and after shifting to TAF therapy.

In this study, investigators will enroll 100 entecavir and 100 TDF treated CHB patients who will switch to TAF and then follow for one year. Demographic, liver function tests, sugar profiles, lipid profiles, ASCVD risk score, body weight, body weight, body height, and waist circumference will be checked and recorded periodically.

Investigators anticipated that body weight will change significantly after switching to TAF in both entecavir and TDF group and may associated with increased risk of cardiovascular risk.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Descrizione dettagliata

Currently, three oral nucleoside/tides analogues (NUC), including entecavir(ETV), tenofovir disoproxil fumarate (TDF), and tenofovir alafenamide (TAF), are available as the first line of treatment option for chronic hepatitis B (CHB) in Taiwan. Among them, TDF exhibits a greater decline of cholesterol, High-density lipoprotein(HDL), and low-density lipoprotein (LDL) levels than entecavir, while the impact of such general lipid-lowering effects on the risk of atherosclerotic cardiovascular diseases (ASCVD) remains unclear. For metabolic features, the evidence comes from HIV patients treated with TDF or TAF containing anti-retroviral therapy (ART). In one study revealed that a 0.45 kg/m2 increase of body mass index (BMI) and a 13% of increase in ASCVD risk score after switching from TDF-containing to TAF-containing ART. Weight gain after starting ART has been reported to associate with lower mortality in initial under-weight or normal-weight HIV patients. However, a study compared the efficacy and safety of dolutegravir/TAF/emtricitabine, dolutegravir/TDF/emtricitabine, and EFV/TDF/emtricitabine and revealed that patients receiving TAF and TDF containing regimens significantly increased body weight. The subsequent body composition analysis showed weight gain mainly resulted from increased lean muscle and fat of trunk and limb. A previous study also showed that the ART-associated increase in muscle area, regardless of regimen, is likely a reflection of increased fat within the muscle that may associate with weakness of muscle strength, risk of fall, and a decline of physical activities.

Overall, in HIV-infected patients, TAF-containing regimens had been shown to increase body weight resulting from increased fat and muscle of trunk and limb. However, it remains unknown whether all these findings in HIV infected patients could be similarly observed in CHB patient receiving TAF therapy, which is commonly encountered in Asia-Pacific region. Moreover, the mechanisms underlying these changes are still unclear. The long-term clinical impact of the BW gain and associated metabolic derangement is also unknown.

Tipo di studio

Osservativo

Iscrizione (Anticipato)

250

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Taiwan
      • Tainan, Taiwan, 704
        • Reclutamento
        • National Cheng-Kung University Hospital
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Pin-Nan Cheng

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 20 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

Sì

Sessi ammissibili allo studio

Tutto

Metodo di campionamento

Campione di probabilità

Popolazione di studio

Chronic hepatitis B patients who have been treated with TDF (n=100) or entecavir (n=100) will switch to TAF.

In entecavir switch group, at least 30 patients should have baseline BW data before entecavir treatment. The indications of entecavir switching to TAF include suboptimal HBV suppression (defined as detectable HBV DNA after at least one year of entecavir treatment), adverse events due to entecavir, patient's decision, and physician's judgement according to clinical conditions.

The scheduled treatment duration from enrolment should be greater than one year. Treatment indications for HBeAg-positive chronic hepatitis B, HBeAg-negative chronic hepatitis B and liver cirrhosis are based on reimbursement criteria of Taiwan government.

Descrizione

Inclusion Criteria:

  1. Age more than 20 years.
  2. Chronic hepatitis B virus infection defined as presence of positive HBsAg more than 6 months.
  3. TAF naïve.
  4. Patients already receiving TDF or entecavir treatment, and the scheduled NUC treatment from enrolment being greater than one year.

Exclusion Criteria:

  1. Other etiology of chronic hepatitis.
  2. Severe comorbid disorders.
  3. Patients with History of acute coronary syndrome, myocardial infarction, stable angina, coronary/other arterial revascularization, stroke, transient ischemic attack, or peripheral arterial disease from atherosclerosis.
  4. Uncontrolled diabetes mellitus (HBA1c > 8.5%).
  5. Current evidence or suspicious of malignancy.
  6. eGFR <50 ml/min/1.73m2.
  7. Any one of following hematology or biochemical or clinical abnormalities indicating the presence of liver decompensation: Albumin <3.5g/dL, Total Bilirubin >2.5mg/dL, prothrombin time prolongation >4 sec or INR >1.7, platelet count <100 x 103 uL, and history or presence of ascites or hepatic encephalopathy.
  8. Child-bearing age women without the willing to contraceptive control, or lactating or pregnant women.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Tenofovir Disoproxil Fumarate(TDF) switch to TAF
The indications of TDF switching to TAF due to adverse events of TDF or physician's judgement according to clinical conditions.
Entecavir(ETV)switch to Tenofovir Alafenamide(TAF)
In entecavir switch group, at least 30 patients should have baseline BW data before entecavir treatment. The indications of entecavir switching to TAF include suboptimal HBV suppression (defined as detectable HBV DNA after at least one year of entecavir treatment), adverse events due to entecavir, physician's judgement according to clinical conditions.
observation groups with take either entecavir (25patients) or TDF (25 patients).
observation groups with total 50 patients who continuously take either entecavir (25patients) or TDF (25 patients) will be enrolled.Examination schedules for these two additional groups are the same as switching groups.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
1.Body weight changes after shifting to TAF treatment.
Lasso di tempo: 48 weeks
Collection Body weight data before and after treatment.
48 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
2.Changes of lipid and sugar profiles before and after shifting to TAF treatment.
Lasso di tempo: 48 weeks.
Collection lipid( include TG<mg/dl>/Chol<mg/dl>,/LDL<mg/dl>/ HDL<mg/dl>) data and sugar profiles(include Insulin<uU/ml>, fasting sugar<mg/dl>, glycosylated hemoglobin<%>) data before and after treatment.
48 weeks.
3.Virologic responses following TAF treatment.
Lasso di tempo: 48 weeks.
Collection Virologic data (e.g HBV DNA<IU/ml>,)before and after treatment.
48 weeks.
4.Renal function after shifting to TAF treatment.
Lasso di tempo: 48 weeks.
Collection Renal function(include Cr<mg/dL>/eGFR<ml/min/1.73m2>)data before and after treatment.
48 weeks.
5. ASCVD score changes before and after shifting to TAF treatment.
Lasso di tempo: 48 weeks.
Collection ASCVD score before and after treatment.
48 weeks.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cheng-Kung University Hospital

Investigatori

  • Investigatore principale: Pin-Nan Cheng, PhD, National Cheng-Kung University Hospital

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

4 giugno 2020

Completamento primario (Anticipato)

31 dicembre 2022

Completamento dello studio (Anticipato)

31 dicembre 2022

Date di iscrizione allo studio

Primo inviato

5 maggio 2021

Primo inviato che soddisfa i criteri di controllo qualità

11 maggio 2021

Primo Inserito (Effettivo)

14 maggio 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

14 maggio 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

11 maggio 2021

Ultimo verificato

1 luglio 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • B-ER 109-100

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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