PRELIMINARY EVALUATION OF SECURITY AND ANTIVIRAL ACTIVITY OF OPEN TREATMENT WITH ENTECAVIR IN PATIENTS WITH CHRONIC HEPATITIS B AFTER HAVING RECEIVED ENTECAVIR AS MONOTHERAPY IN OTHER CLINICAL TRIALS

Not Applicable

• Conditions: -K753 Granulomatous hepatitis, not elsewhere classified; Granulomatous hepatitis, not elsewhere classified; K753

• Registration Number: PER-043-03
• Lead Sponsor: BRISTOL MYERS SQUIBB COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-08-13
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Men and women> 16 years of age
- Failed adefovir therapy (ie, experienced viremia according to the definition of AI463048 protocol:> 104 copies / ml of HBV serum DNA using the PCR technique and a reduction <2 log10 from baseline in the serum DNA of HBV determined by technique
RCP) on the basis of the results of the laboratory samples of roalized or doped patients for at least 24 weeks of treatment;
- Demonstrated intolerance to adefovir, for which both the investigator and the Central Medical Monitor of BMS agree that this prevents the continuation of adefovir treatment;
- They have a partial response (<104 copies / ml of serum HBV DNA using the PCR technique, or a reduction> 2 logio from baseline in the serum DNA of the HBV determined by the PCR technique, with persistence of HBeAg in subjects with positive results in the visit
baseline and / or abnormal ALT (> 1.25 X ULN)) after completing 96 weeks of therapy.

Exclusion Criteria

• Concomitant infection by human immunodeficiency virus (HIV).
• Therapy with nephrotoxic agents (excluding immunosuppressive agents in transplant recipients) or hepatotoxic agents, such as aminoglycosides, amphotericin B, foscamet, carbamazepine.
• Hemoglobin <11.0 g / dl (<110 g / 1) except for those coming from study AI463048. For AI463048 subjects, cases with hemoglobin <8.0 g / dl (<80 g / 1) should be consulted with the Medical Monitor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified