A randomized, open-label, controlled, multi-center two-year study comparing efficacy and safety of telbivudine (LDT600) 600 mg PO in combination with peg alpha-2a sq 180 µg with peg alpha-2a monotherapy, and with telbivudine monotherapy in treatment naïve patients with HBeAg-positive CHB.
- Conditions
- hepatitis B10047438liver inflammation
- Registration Number
- NL-OMON30611
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 10
1. Male or female, at least 18 years of age.
2. Documented Cronic Hepatitis B (CHB) defined by all of the following:
*Clinical history compatible with CHB
*Detectable serum HBsAg at the Screening visit and at least 6 months prior
*HBeAg-positive at the Screening visit
*HBeAb-negative at the Screening visit
*Documented history of evidence of chronic liver inflammation,
*Elevated serum ALT level (1.3 * 10 x upper limit of normal (ULN)) at screening
*Serum HBV DNA level * 6 log10 copies/mL (central lab), at screening
*Documented chronic liver inflammation on previous liver biopsy within the previous 24 months
1. History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures or their excipients.
2. Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or Human immunodeficiency virus (HIV).
3. Current or passed use of excluded drug therapy e.g. other investigational therapy, immunomodulatory treatment, nucleoside or nucleoitide therapy
4. Medical condition requiring prolonged use of corticosteroids, hepatotoxic drugs or nephrotoxic drugs.
5. Alcohol or illicit drug abuse within the preceding 2 years
6. Patient is on thyroid therapy and dose is not stable for at least 5 weeks prior to Visit 2/Baseline
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary efficacy variable of this study is the proportion of patients who<br /><br>will achieve HBV DNA non-detectability by PCR at Week 52.<br /><br><br /><br>The proportion of patients (response rate) who will achieve HBV DNA<br /><br>non-detectability at Week 52 and ALT normalization after 52 weeks* treatment<br /><br>will be tested using the CMH test, stratified by country and/or baseline HBV<br /><br>DNA level. The ratio of the response rates and the difference of the response<br /><br>rates for combination therapy vs. peginterferon alfa-2a monotherapy will be<br /><br>provided along with a 95% confidence interval.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The proportion of patients (response rate) who will achieve HBV DNA<br /><br>non-detectability at Week 52 and ALT normalization after 52 weeks* treatment<br /><br>will be tested using the CMH test.</p><br>