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NCT00128544 Clinical Trial

Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients With Chronic Hepatitis B

Hepatitis B Clinical Trial

Official title:
A Randomized, Blinded, Phase IIb Trial of Telbivudine (LdT) Versus the Combination of Telbivudine and Valtorcitabine (Val-LdC) in Patients With Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00128544
Other study ID # NV-02C-004
Secondary ID
Status Completed
Phase Phase 2
First received August 8, 2005
Last updated June 15, 2017
Start date May 2005
Est. completion date May 2007

Study information
Verified date June 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study is being conducted to compare the effectiveness of the combination of valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date May 2007
Est. primary completion date May 2007
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Clinical history compatible with compensated chronic hepatitis B

Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Patient is pregnant or breastfeeding

- Patient is co-infected with hepatitis C virus, hepatitis D virus or HIV

- Patient has previously received lamivudine, adefovir dipivoxil or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide at anytime.

Other protocol-defined exclusion criteria may apply.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• telbivudine

• valtorcitabine

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Novartis Novartis Pharmaceuticals

Countries where clinical trial is conducted

Hong Kong,  New Zealand,  Singapore, 

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