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Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir

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ClinicalTrials.gov Identifier: NCT03236584
Recruitment Status : Active, not recruiting
First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Chang Wook Kim, Uijeongbu St. Mary Hospital

Tracking Information
First Submitted Date  ICMJE July 28, 2017
First Posted Date  ICMJE August 2, 2017
Last Update Posted Date August 2, 2017
Actual Study Start Date  ICMJE September 1, 2015
Estimated Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2017)
SVR [ Time Frame: 48 WEEK ]
Proportion of patients with a sustained virological response (serum HBV DNA <20 IU/mL) at week 48
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tenofovir Monotherapy in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir
Official Title  ICMJE Investigation of Efficacy of Tenofovir Monotherapy in Comparison With Lamivudine Plus Adefovir in Patients With Chronic Hepatitis B Patients Who Had Achieved Complete Viral Suppression on Lamivudine Plus Adefovir Combination Therapy - Multicenter Randomized Open-label Controlled Trial
Brief Summary Little is known about efficacy of switching to tenofovir monotherapy for lam-resistant chronic hepatitis B patients who achieved a complete virological response to lamivudine plus adefovir. This study was to investigate the efficacy of switching to tenofovir monotherapy for lamivudine -resistant chronic hepatitis B patients with undetectable hepatitis B virus DNA while on lamivudine plus adefovir combination therapy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Proportion of Patients With a Sustained Virological Response (Serum HBV DNA <20 IU/mL) at Week 48
Intervention  ICMJE
  • Drug: lamivudine plus adefovir combination
    continuing lamivudine plus adefovir
  • Drug: Tenofovir Disoproxil Fumarate
    switching to tenofovir
Study Arms  ICMJE
  • Active Comparator: lamivudine adefovir
    Intervention: Drug: lamivudine plus adefovir combination
  • Experimental: tenofovir
    Intervention: Drug: Tenofovir Disoproxil Fumarate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 28, 2017)
76
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 30, 2019
Estimated Primary Completion Date March 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HBsAg (+) for > 6 months age >19 years antiviral resistance to LAM (rtL180M and/or M204V/I) currently receiving LAM plus ADV for more than 12 months HBV DNA levels <20 IU/ml on two consecutive tests of 3-month interval

Exclusion Criteria:

  • Cr ≥1.5 mg/dL Evidence of decompensated liver disease Malignant neoplasm Coinfection with HIV, HCV
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03236584
Other Study ID Numbers  ICMJE UC15MISI0099
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Chang Wook Kim, Uijeongbu St. Mary Hospital
Study Sponsor  ICMJE Uijeongbu St. Mary Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Uijeongbu St. Mary Hospital
Verification Date July 2017

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