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

Information source: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis B

Intervention: Tenofovir (Drug); Telbivudine (Drug); Tenofovir plus Telbivudine (Drug)

Phase: N/A

Status: Withdrawn

Sponsored by: Institute of Liver and Biliary Sciences, India

Official(s) and/or principal investigator(s):
Dr S. K. Sarin, MD, DM, Principal Investigator, Affiliation: Institute of Liver & Biliary Sciences

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone

Secondary outcome:

Percentage change in serum HBV DNA levels

Percentage of patients with ALT normalization

Percentage of patients with reduction in HBsAg concentration by >50%

Percentage of patients with virological breakthrough

Percentage of patients with primary treatment failure

Occurrence of adverse events

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Institute of Liver & Biliary Sciences, New Delhi, India
Additional Information

Starting date: June 2011
Last updated: June 15, 2015

Page last updated: August 23, 2015

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