Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Institute of Liver and Biliary Sciences, India.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01260610
First received: December 14, 2010
Last updated: June 28, 2011
Last verified: June 2011

December 14, 2010
June 28, 2011
June 2011
January 2013   (final data collection date for primary outcome measure)
Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone [ Time Frame: 6 Months and 2 Years ] [ Designated as safety issue: No ]
Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01260610 on ClinicalTrials.gov Archive Site
  • Percentage change in serum HBV DNA levels [ Time Frame: Baseline and 2 Years ] [ Designated as safety issue: No ]
  • Percentage of patients with ALT normalization [ Time Frame: Baseline and 2 Years ] [ Designated as safety issue: No ]
  • Percentage of patients with reduction in HBsAg concentration by >50% [ Time Frame: Baseline and 2 Years ] [ Designated as safety issue: No ]
  • Percentage of patients with virological breakthrough [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with primary treatment failure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
  • Percentage change in serum HBV DNA levels [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Percentage of patients with ALT normalization [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Percentage of patients with reduction in HBsAg concentration by >50% [ Time Frame: 2 Years ] [ Designated as safety issue: No ]
  • Percentage of patients with virological breakthrough [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Percentage of patients with primary treatment failure [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Occurance of adverse events [ Time Frame: 2 Years ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients
An Exploratory, Randomized, Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug Alone in HBeAg Negative Chronic Hepatitis B Patients

Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. Thus this study is carried out to determine the efficacy and safety of combination of tenofovir plus telbivudine (two most potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week open labelled, prospective, randomized, multicentric study. The patient will receive either tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the non-responders (ie HBV-DNA > 300 copies/ ml) will be switched to combination arm and will continue receiving tenofovir plus telbivudine for 104 weeks.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: Tenofovir
    300 mg of Tenofovir daily
  • Drug: Telbivudine
    600 mg of Telbivudine daily
  • Drug: Tenofovir plus Telbivudine
    Tenofovir (300 mg daily) plus Telbivudine (600 mg daily)
  • Active Comparator: Tenofovir
    Intervention: Drug: Tenofovir
  • Active Comparator: Telbivudine
    Intervention: Drug: Telbivudine
  • Experimental: Tenofovir plus Telbivudine
    Intervention: Drug: Tenofovir plus Telbivudine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
90
August 2013
January 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • HBeAg negative at screening
  • Documented chronic Hepatitis B
  • Treatment naive
  • Compensated liver disease

Exclusion Criteria:

  • Chronic Hepatitis B with Child Pugh B & C
  • HBeAg positive
  • Decompensated liver disease
Both
18 Years to 65 Years
No
Contact: Dr Manoj Kumar, MD, DM +91-11-64659881 manojkumardm@gmail.com
Contact: Dr Tarandeep Singh, MBBS, PhD +91-11-64659881 drtarandeep@gmail.com
India
 
NCT01260610
CLDT600AIN05T
No
Dr Manoj Kumar, Institute of Liver & Biliary Sciences
Institute of Liver and Biliary Sciences, India
Not Provided
Principal Investigator: Dr S. K. Sarin, MD, DM Institute of Liver & Biliary Sciences
Institute of Liver and Biliary Sciences, India
June 2011

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