An Open Label Trial of Telbivudine (LdT) in Adults with Chronic Hepatitis B Previously Treated in Idenix-Sponsored Telbivudine Studies
- Conditions
- chronic hepatitis BMedDRA version: 9.1Level: LLTClassification code 10008910Term: Chronic hepatitis B
- Registration Number
- EUCTR2004-004274-87-CZ
- Lead Sponsor
- ovartis Pharma Services AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2000
The study population will comprise patients with chronic hepatitis B who have successfully completed a previous Idenix-sponsored study, as follows. Patients must meet all of the following inclusion criteria:
1. Patient completed a previous qualifying Idenix-sponsored Phase IIb, III, or IIIb trial in the telbivudine clinical development program, and will 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. The previous qualifying trials include the following:
Phase IIB trial
1. NV-02B-010
Phase IIb extension trial Phase III-IIIb trials
1. NV-02B-007 trial, for patients with compensated chronic hepatitis B
2. NV-02B-011 trial, for patients with decompensated HBV cirrhosis
3. NV-02B-015 trial, supplemental Phase III trial in China
4. NV-02B-018 trial, telbivudine vs. adefovir
5. NV-02B-019 trial, switch” trial for lamivudine-treated patients
(Other qualifying trials may be added by amendment, as the telbivudine global clinical development program advances).
2. Patient was not 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 Groups 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 participate in the study
Are the trial subjects under 18? no
Number of subjects for this age range:
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
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 test at Baseline.
2. Patient is of reproductive potential (men and women) and unwilling to use double barrier method of contraception. It is required that double barrier method of contraception be used (i.e. condom with spermicide or diaphragm with spermicide) by patients of reproductive potential (men and women) regardless of whether a hormonal agent also is used as a method of contraception.
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 insufficiency 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)×(wt. in kg)]/[(serum creatinine in g/dL)×(72)] • Calculation for Females: CrCl (mL/min) = 0.85 x [(140-age in yr)×(wt. in kg)]/[(serum creatinine in mg/dL)×(72)]
5. Since entry into the qualifying prior study, patient has developed a concurrent medical or psychosocial condition that will confound the efficacy or safety assessments in the current study, or may preclude the patient’s compliance with the visit schedule or study drug regimen in the present study. Examples of such intercurrent conditions include, but are not limited to: unstable cardiovascular or pulmonary disease; active malignancy requiring intensive surgical or medical management; unstable diabetes or other poorly controlled endocrine disease; poorly controlled seizure disorder, neuropsychiatric disorder associated with severe depression, suicidal ideation, or psychosis; or change in social or geographic circumstances that would likely interfere with compliance with the protocol requirements.
6. Patient is currently abusing alcohol or illicit drugs. For the purposes of the present study, alcohol abuse is defined as frequent consumption of alcoholic beverages with an average daily intake of more than 40g of ethanol or any lesser amount that would, in the investigator’s opinion, interfere with the study evaluations.
7. Patient is enrolled or plans to enroll in another clinical trial of an investigational agent while participating in this study.
8. All other treatments for hepatitis B, including commercially available treatments indicated for conditions other than chronic hepatitis B that are being investigated to treat or may have activity against HBV (e.g., ribavirin, famciclovir, ganciclovir, etc).
9. Prolonged use of systemic acyclovir or famciclovir defined as episodic treatment with these agents for periods exceeding 10 days every 3 months, or chronic suppressive therapy.
10. Systemic immunomodulators of any type.
11. Systemic corticosteroids (topical and inhaled corticosteroids are permitted).
12. Herbal medications known to cause hepatotoxicity ( e.g., St. John’s Wart, Kava, Jin Bu Huan, Yuzhitang, germander, chaparral, shark cartilage, mistletoe, slim 10, Lipokinetix, etc.).
13. Patient has any of the following laboratory values: • Hemoglobin < 9 g/dL for men or < 8 g/dL for women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method