Clinical trial NCT00537537: To Evaluate Antiviral Efficacy of Telbivudine in Hepatitis B Antigen Positive (HbeAg-positive) Compensated Chronic Hepatitis B (CHB)
Official title: An Open Label, Response Adaptive Study of Telbivudine in Adults With HBeAg Positive Compensated CHB
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis B, Chronic
Keywords: Hepatitis B, Chronic, Hepatitis B e Antigen positive, Adults, Telbivudine, Adefovir
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the antiviral efficacy of add-on adefovir to telbivudine in non-responders to telbivudine monotherapy after 24 and 36 initial weeks. Antiviral efficacy is assessed by hepatitis B virus (HBV) DNA non-detectability (PCR \<300 copies/ml) by week 104 with CHB.


Eligibility 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

Primary outcomes:
measure: Antiviral efficacy with adefovir combination assessed by HBV DNA non-detectability (PCR <300 copies/ml) by week 104.
Secondary outcomes:
measure: Antiviral efficacy with telbivudine alone assessed by HBV DNA non-detectability (PCR <300 copies/ml) at week 24 and 36.
measure: HBeAg loss & HBeAg seroconversion (defined as a loss of HBeAg and a gain of detectable level of HBeAb).
measure: Alanine Transaminase (ALT) normalization, in patients with raised levels at baseline.
measure: Change in HBV DNA level (log10 copies/ml) from baseline to week 4, 8, 12, 24, 36, 52, 76 and 104.
measure: Viral breakthrough, defined as increase of HBV DNA by 1 log10 copies/ml from treatment nadir, at any point after week 24.
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: Novartis Investigative Site
city: Mumbai
country: India
facility: Novartis Investigative Site
city: Vellore
country: India
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References: