An open label trial of Telbivudine (LdT) in adults with chronic hepatitis B previously treated in Idenix-sponsored Telbivudine studies - NV-02B-022

• Conditions: Chronic Hepatitis B; MedDRA version: 14.1Level: PTClassification code 10019731Term: Hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2004-004274-87-IT
• Lead Sponsor: OVARTIS PHARMA AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-18
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Patients must meet all of the following inclusion criteria:
1. Patient completed a previous qulaifyng Idenix-sponsored Phase IIb, III, or IIIb trial in the telbivudine clinical development program, and with be available to immediately rollover into this study with no discontinuation of study drug. For patients who have achieved efficacy responses in their previous trial and are eligible to enter Group C in this study, rollover into the present study should be immediate whenever possible and in any case must be within 30 days of completion of the previous trial.
2. Patient was no discontinued from the previous Idenix-sponsored study due to a serious adverse event (SAE), other adverse event, laboratory abnormality, disease progression, virologic breakthrough, or treatment failure.
3. Patients in group A and B must be HBsAg positive.
4. Patient is willing and able to comply with the study drug regimen and all other study requirements.
5. The patient is willing and able to provide written informed consent to partecipate in the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study for any of the following reasons:
1. Patient is pregnant or breastfeeding.Women of childbearing potential must have a negative urine pregnancy test at Baseline.
2. Patient is childbearing potential (men and woman) and unwilling to use double barrier method of contaception. It is required that double barrier method of contaception be used (i.e. condom with spermicide or diaphragm with spermicide)by patient of childbearing potential (men and woman)regardless of whether a hormonal agent also is used as a method of contaception.
3. Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV. Patients will be tested for antibodies to HCV, HIV, and HDV in the BAseline assessments performed at the central laboratory. If the patient is found to be coinfected with HDV, HCV, or HIV they will be discontinued from the study at or before the next scheduled study visit.
4. Patient has evidence of renal insifficency defined as patient requiring dialysis or having an estimated creatinine clearance below 50 mL/min, as estimated by the Cockcroft-Gault formula:
Calculation for Males:
CrCl(mL/min)=(140-age in yr)x(wt in Kg)/(serum creatinine in g/dL)x(72)
Calculation for females:
CrCl(mL/min)=0.85x(140-age in yr)x(wt in Kg)/(serum creatinine in g/dL)x(72)

For further Exclusion criteria please refer to the Protocol version 3 18 may 2005 pag. 40

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified