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

Chronic Hepatitis B Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01260610
• Other study ID #: CLDT600AIN05T
• Status: Withdrawn
• Phase: N/A
• First received: December 14, 2010
• Last updated: June 15, 2015
• Start date: June 2011
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Tenofovir
300 mg of Tenofovir daily
• Telbivudine
600 mg of Telbivudine daily
• Tenofovir plus Telbivudine
Tenofovir (300 mg daily) plus Telbivudine (600 mg daily)

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of combination of telbivudine plus tenofovir vs monotherapy with either drug alone		6 Months and 2 Years	No
Secondary	Percentage change in serum HBV DNA levels		Baseline and 2 Years	No
Secondary	Percentage of patients with ALT normalization		Baseline and 2 Years	No
Secondary	Percentage of patients with reduction in HBsAg concentration by >50%		Baseline and 2 Years	No
Secondary	Percentage of patients with virological breakthrough		24 weeks	No
Secondary	Percentage of patients with primary treatment failure		12 weeks	No
Secondary	Occurrence of adverse events		2 Years	Yes