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

This study is currently recruiting participants.
Verified June 2011 by Institute of Liver and Biliary Sciences, India
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
History of Changes
  Purpose

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.


Condition Intervention
Chronic Hepatitis B
 Drug: Tenofovir
Drug: Telbivudine
Drug: Tenofovir plus Telbivudine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory, Randomized, Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug Alone in HBeAg Negative Chronic Hepatitis B Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: June 2011
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Tenofovir Drug: Tenofovir
300 mg of Tenofovir daily
Active Comparator: Telbivudine Drug: Telbivudine
600 mg of Telbivudine daily
Experimental: Tenofovir plus Telbivudine Drug: Tenofovir plus Telbivudine
Tenofovir (300 mg daily) plus Telbivudine (600 mg daily)

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01260610

Contacts
Contact: Dr Manoj Kumar, MD, DM +91-11-64659881 manojkumardm@gmail.com
Contact: Dr Tarandeep Singh, MBBS, PhD +91-11-64659881 drtarandeep@gmail.com

Locations
India
Institute of Liver & Biliary Sciences Recruiting
New Delhi, India
Contact: Dr Manoj Kumar, MD, DM     +91-11-64659881     manojkumardm@gmail.com    
Contact: Dr Tarandeep Singh, MBBS, PhD     +91-11-64659881     drtarandeep@gmail.com    
Sub-Investigator: Dr Manoj Kumar, MD, DM            
Sub-Investigator: Dr Tarandeep Singh, MBBS, PhD            
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India
Investigators
Principal Investigator: Dr S. K. Sarin, MD, DM Institute of Liver & Biliary Sciences
  More Information

No publications provided

Responsible Party: Dr Manoj Kumar, Institute of Liver & Biliary Sciences
ClinicalTrials.gov Identifier: NCT01260610     History of Changes
Other Study ID Numbers: CLDT600AIN05T
Study First Received: December 14, 2010
Last Updated: June 28, 2011
Health Authority: India: Ministry of Health

Keywords provided by Institute of Liver and Biliary Sciences, India:
Hepatitis B, Tenofovir, Telbivudine

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
 DNA Virus Infections
Tenofovir
Tenofovir disoproxil
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 16, 2013