Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01341743
First received: February 16, 2011
Last updated: October 28, 2013
Last verified: September 2013

February 16, 2011
October 28, 2013
December 2010
June 2014   (final data collection date for primary outcome measure)
proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01341743 on ClinicalTrials.gov Archive Site
  • serum HBV DNA reduction from baseline at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with ALT normalization at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with HBeAg loss and seroconversion at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
  • The proportion of subject with HBsAg loss and seroconversion at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
  • serum HBV DNA reduction from baseline at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with ALT normalization at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with HBeAg loss and seroconversion at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
  • The proportion of subject with HBsAg loss and seroconversion at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
  • The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
  • serum HBV DNA reduction from baseline at week 12 [ Time Frame: week 12 ] [ Designated as safety issue: No ]
  • serum HBV DNA reduction from baseline at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • serum HBV DNA reduction from baseline at week 36 [ Time Frame: week 36 ] [ Designated as safety issue: No ]
  • serum HBV DNA reduction from baseline at week 48 [ Time Frame: week 48 ] [ Designated as safety issue: No ]
  • serum HBV DNA reduction from baseline at week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • serum HBV DNA reduction from baseline at week 64 [ Time Frame: week 64 ] [ Designated as safety issue: No ]
  • serum HBV DNA reduction from baseline at week 76 [ Time Frame: week 76 ] [ Designated as safety issue: No ]
  • serum HBV DNA reduction from baseline at week 88 [ Time Frame: week 88 ] [ Designated as safety issue: No ]
  • The proportion of subjects with ALT normalization at week 24 [ Time Frame: week 24 ] [ Designated as safety issue: No ]
  • The proportion of subjects with ALT normalization at week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • The proportion of subjects with HBeAg loss and seroconversion at week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • The proportion of subject with HBsAg loss and seroconversion at week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
  • The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 52 [ Time Frame: week 52 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
A Multi-center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Generic Entecavir Monotherapy or in Combination With Adefovir for Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hepatitis B
  • Drug: Entecavir
    patients will receive oral entecavir 1mg, daily for 104 weeks.
  • Drug: Entecavir, Adefovir
    patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
  • Drug: Entecavir, Adefovir
    patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
  • Active Comparator: A
    oral entecavir 1mg daily for 104 weeks
    Intervention: Drug: Entecavir
  • Active Comparator: B
    oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
    Intervention: Drug: Entecavir, Adefovir
  • Active Comparator: C
    oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
    Intervention: Drug: Entecavir, Adefovir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
360
December 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female aged 18-65 years;
  • Capable of understanding and signing the informed consent. Willing to comply with the study requirements;
  • Serum HBsAg positive and ALT<10ULN at study screening;
  • Patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;

Exclusion Criteria:

  • History of viral breakthrough or genotypic resistance on previous therapy;
  • History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;
  • Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of possible HCC;
  • Other protocol defined exclusion criteria.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01341743
MOH-04
Yes
Nanfang Hospital of Southern Medical University
Nanfang Hospital of Southern Medical University
JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
Principal Investigator: JinLin Hou, MD Nanfang Hospital of Southern Medical University
Nanfang Hospital of Southern Medical University
September 2013

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