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Switching to Tenofovir Versus Continuing Entecavir in Chronic Hepatitis B Patients With Partial Virologic Response During Entecavir Therapy: STEEP Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Korea University
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Hyung Joon Yim, Korea University
ClinicalTrials.gov Identifier:
NCT01711567
First received: October 17, 2012
Last updated: February 26, 2014
Last verified: February 2014

October 17, 2012
February 26, 2014
April 2013
December 2014   (final data collection date for primary outcome measure)
Virologic response rate at year 1 (12 months) (HBV DNA < 20 IU/mL) [ Time Frame: up to the end of year 1 (12 months) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01711567 on ClinicalTrials.gov Archive Site
-Degree of HBV DNA reduction, mean HBV DNA, biochemical and serologic response rates, resistance, and adverse events at year 1 [ Time Frame: up to the end of year 1 (12 months) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Switching to Tenofovir Versus Continuing Entecavir in Chronic Hepatitis B Patients With Partial Virologic Response During Entecavir Therapy: STEEP Study
Not Provided

Entecavir, a potent antiviral agent, has been widely used for treatment-naïve chronic hepatitis B patients. However, about 20% of patients showed partial virologic response after 2 year of entecavir therapy (33% in HBeAg positive, 10% in HBeAg negative patients). Tenofovir is a nucleotide analogue with more potent antiviral activity. In addition, there is no cross resistance between the two drugs. Therefore it is assumed that tenofovir would be effective in the treatment of chronic hepatitis B patients who shows partial virologic response (detectable HBV DNA by real time PCR after 12 months of treatment) despite treatment with entecavir. In this study, we will compare the efficacy of switching to tenofovir with continuing entecavir in patients who shows partial virologic response to entecavir.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: tenofovir
    tenofovir 300 mg qd
    Other Name: tenofovir (viread)
  • Drug: entecavir
    entecavir 0.5 mg qd
    Other Name: entecavir(baraclude) 0.5 mg qd
  • Active Comparator: entecavir
    standard drugs
    Intervention: Drug: entecavir
  • Active Comparator: tenofovir
    study drugs
    Intervention: Drug: tenofovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
110
December 2015
December 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. CHB patients (positive HBsAg more than 6 months)
  2. Age 19 years old
  3. HBeAg positive or negative patients
  4. Patients receiving entecavir 0.5 mg more than 12 months
  5. Detectable HBV DNA by real time PCR (HBV > 60 IU/mL)
  6. Compensated liver function (Child-Pugh-Turcotte score ≤7, prothrombin time 3 sec above ULN or INR ≤1.5, serum albumin >3 g/dL, total bilirubin <2.5 mg/dL, no history of variceal bleeding, diuretics or ascites requiring paracentesis, hepatic encephalopathy)

Exclusion Criteria:

  1. History of treatment with nucleotide analogue
  2. Detectable entecavir resistant mutation by RFMP
  3. Decompensated cirrhosis (CTP score >7)
  4. Patients with HCC
  5. Seropositivity to HCV, HDV or HIV
  6. Pregnant and lactating woman
Both
19 Years and older
No
Contact: Hyung Joon Yim, M.D. 82-31-412-5583 gudwns21@medimail.co.kr
Contact: Sang Jun Suh, M.D. 82-31-412-4926 mothpickle@naver.com
Korea, Republic of
 
NCT01711567
STEEP study
Yes
Hyung Joon Yim, Korea University
Korea University
Gilead Sciences
Principal Investigator: Hyung Joon Yim, M.D. Korea University
Korea University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP