To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00537537
• Date of registration: 27/09/2007
• Prospective Registration: No
• Primary sponsor: Novartis Pharmaceuticals
• Public title: To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB)
• Scientific title: An Open Label, Response Adaptive Study of Telbivudine in Adults With HBeAg Positive Compensated CHB
• Date of first enrolment: August 2007
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00537537
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

India

Contacts

• Name: Novartis
• Affiliation: Novartis

Key inclusion & exclusion criteria

Inclusion Criteria:

Male or female, at least 18 yrs of age; HBsAg positive, HBeAg positive and anti-HBe
negative at the time of screening; Quantifiable serum HBV DNA levels of >105copies/ml; ALT
levels any level; Treatment naïve; Baseline liver histology in case of ALT levels within
normal limits performed within last 12 months) indicative of chronic hepatitis B changes
Metavir score F >2; Willing and able to comply with the study drug regimen and all other
study requirements; The patient or guardian is willing and able to explore written informed
consent to participate in the study. Exclusion Criteria:

Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative
serum beta-human chorionic gonadotropin (HCG) at Screening visit; Patient is of
childbearing potential (men and women) and unwilling to use a barrier method of
contraception. It is required that a barrier method of contraception be used (i.e. condom
with spermicide or diaphragm with spermicide) by patients of childbearing potential (men
and women) regardless of whether a hormonal agent also is used as a method of
contraception; Patient is co infected with hepatitis C virus (HCV), HIV. Patients will be
tested for antibodies to HCV & HIV in the Screening assessments;Patient has a medical
condition that requires prolonged or frequent use of systemic acyclovir or famciclovir;
Patient is currently abusing alcohol or illicit drugs, or has a history of alcohol abuse or
illicit substance abuse within the preceding two years; Patient has a medical condition
that requires frequent or prolonged use of systemic corticosteroids; Patients who has been
on warfarin or other anticoagulants during 30 days prior to screening or if expected during
the present study; Patient has any other concurrent medical condition, at clinician's
discretion, likely to preclude compliance with the schedule of evaluations in the protocol,
or likely to confound the efficacy or safety observations of the study Other protocol
defined inclusion/exclusion criteria may apply



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hepatitis B, Chronic

Intervention(s)

Drug: Telbivudine

Primary Outcome(s)

Antiviral efficacy with adefovir combination assessed by HBV DNA non-detectability (PCR <300 copies/ml) by week 104.

Secondary Outcome(s)

Viral breakthrough, defined as increase of HBV DNA by 1 log10 copies/ml from treatment nadir, at any point after week 24.

HBeAg loss & HBeAg seroconversion (defined as a loss of HBeAg and a gain of detectable level of HBeAb).

Alanine Transaminase (ALT) normalization, in patients with raised levels at baseline.

Antiviral efficacy with telbivudine alone assessed by HBV DNA non-detectability (PCR <300 copies/ml) at week 24 and 36.

Change in HBV DNA level (log10 copies/ml) from baseline to week 4, 8, 12, 24, 36, 52, 76 and 104.

Secondary ID(s)

CLDT600AIN01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors