Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B

Chronic Hepatitis B Clinical Trial

— Chinese PAC  

Official title:

An Open-label, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00781105
• Other study ID #: CLDT600ACN03
• Status: Completed
• Phase: Phase 4
• First received: October 27, 2008
• Last updated: February 20, 2017
• Start date: August 1, 2008
• Est. completion date: September 16, 2010

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The "Chinese PAC" study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the proportion of patients achieving undetectable HBV DNA at week 52.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2200
• Est. completion date: September 16, 2010
• Est. primary completion date: September 16, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female 16 to 65 year of age

• Documented CHB defined by detectable serum HBsAg and serum HBV DNA level

• Willing and able to comply with the study drug regimen

• Written informed consent before any assessment

Exclusion Criteria:

• Patient has a history of/or clinical signs/symptoms of hepatic decompensation

• Patient has a history of HCC or findings suggestive of possible HCC

• Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time

• History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes

• Patient has received IFN or other immunomodulatory treatment with 12 months before screening

• Previous treatment history with NRTIs

Other protocol-defined inclusion/exclusion criteria may apply.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Telbivudine
600 mg/day, oral tablets, once daily, 52 weeks

Locations

Country	Name	City	State
China	Novartis Investigative Site	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV DNA PCR negativity rate		at 52 weeks
Secondary	HBV DNA PCR negativity rate		at week 24
Secondary	DNA reduction		from baseline to Weeks 12, 24, 36, 52
Secondary	HBeAg loss rate		at week 52
Secondary	HBeAg seroconversion rate		at week 52
Secondary	ALT normalization rate		at weeks 24 and 52
Secondary	Incidence of AE (SAE,etc), Graded lab abnormalities		at week 52

External Links

•   Results for CLDT600ACN03 from the Novartis Clinical Trials Website