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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01260610
Recruitment Status : Withdrawn (lack of funds)
First Posted : December 15, 2010
Last Update Posted : June 16, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Chronic Hepatitis B Drug: Tenofovir Drug: Telbivudine Drug: Tenofovir plus Telbivudine

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : June 2011
Primary Completion Date : June 2011
Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone [ Time Frame: 6 Months and 2 Years ]

Secondary Outcome Measures :
  1. Percentage change in serum HBV DNA levels [ Time Frame: Baseline and 2 Years ]
  2. Percentage of patients with ALT normalization [ Time Frame: Baseline and 2 Years ]
  3. Percentage of patients with reduction in HBsAg concentration by >50% [ Time Frame: Baseline and 2 Years ]
  4. Percentage of patients with virological breakthrough [ Time Frame: 24 weeks ]
  5. Percentage of patients with primary treatment failure [ Time Frame: 12 weeks ]
  6. Occurrence of adverse events [ Time Frame: 2 Years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01260610


Locations
India
Institute of Liver & Biliary Sciences
New Delhi, India
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

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01260610     History of Changes
Other Study ID Numbers: CLDT600AIN05T
First Posted: December 15, 2010    Key Record Dates
Last Update Posted: June 16, 2015
Last Verified: June 2011

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

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
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
Telbivudine
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents