A Randomized, Double-Blind Trial of Telbivudine (LdT) versus Lamivudine in Adults with Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
- Conditions
- Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
- Registration Number
- EUCTR2004-000443-17-ES
- Lead Sponsor
- Idenix Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
1. Male or female, 16 to 70 years of age.
2. Documented decompensated chronic hepatitis B defined by all of the following:
• Clinical history compatible with decompensated chronic hepatitis B related cirrhosis
• Child-Turcotte-Pugh score > 7 points.
• Evidence of hepatic cirrhosis or portal hypertension, documented by at least one of the following six methods:
i. Evidence of cirrhosis by previous liver biopsy within 5 years prior to Screen,
OR
ii. Evidence of cirrhosis by liver biopsy prior to randomization,
OR
iii. Evidence of cirrhosis by ultrasound, CT, or MRI imaging within 2 years prior to Screen,
OR
iv. Evidence of cirrhosis by ultrasound, CT, or MRI imaging prior to randomization (for patients who are considered high-risk for liver biopsy, due to thrombocytopenia or bleeding diatheses),
OR
v. Evidence of portal hypertension by previous endoscopy demonstrating grade III or IV esophageal varices within 5 years prior to Screen,
OR
vi. Evidence of portal hypertension by documented previous history of related clinical complications (i.e., one or more previous episodes of clinically significant upper gastrointestinal hemorrage related to esophageal varices, or previous episode(s) of spontaneous bacterial peritonitis);
OR
vii. Evidence of portal hypertension by previously measured hepatic venous pressure gradient > 15 mmHg within 2 years prior to Screen
• Detectable serum HBsAg at the Screening visit
• Elevated serum ALT level (1.2 – 10 x ULN) at the Screening visit
3. Serum HBV DNA level = 5 log10 copies/mL, as determined by the PCR assay at the central study laboratory at Screen.
4. Patient is ambulatory.
5. Patient is willing and able to comply with the study drug regimen and all other study requirements.
6. The patient is willing and able to provide written informed consent to participate in the study.
Are the trial subjects under 18? yes
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
1. Patient is pregnant or breastfeeding. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-HCG) at Screen.
2. Patient is of childbearing potential (men and women) and unwilling to use double barrier method of contraception.
3. Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), or HIV.
4. Patient previously received lamivudine, adefovir, or an investigational anti-HBV nucleoside or nucleotide analog at any time. Precluded therapies include, but are not limited to, the following: any previous exposure to lamivudine, adefovir or other PMEA analogs (tenofovir, MCC-478), lobucavir, entecavir, emtricitabine (FTC), L-FMAU, L-Fd4C, or other investigational anti-HBV nucleosides/nucleotides.
5. Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before Screening for this study. Precluded therapies include, but are not limited to, interferon agents (alpha-, beta- or gamma-interferons), thymosin, IL-12, or other putative systemic immunomodulators.
6. Patient has a medical condition that requires prolonged or frequent use of systemic acyclovir or famciclovir (e.g., for recurrent herpes virus infections, etc). Prolonged use means episodic treatment with these agents for periods exceeding 10 days every 3 months, or chronic suppressive therapy.
12. Patient has evidence of renal insufficiency defined as patient requires dialysis or has an estimated creatinine clearance, below 70 mL/min, as estimated by the Cockcroft-Gault formula:
21. Patient has any of the following laboratory values at Screening:
? Hemoglobin < 9 g/dL for men or < 8 g/dL for women
? Total WBC < 1,500/ mm3
? Absolute neutrophil count (ANC) < 1,000/mm3
? Platelet count < 50,000/mm3
? Serum amylase or lipase = 1.5 x ULN
? Serum albumin < 2.5 g/dL
? Total bilirubin = 3 x ULN
? Serum creatinine > ULN
? AFP > 50 ng/mL (requires further work up)
As requested, the most important exclusion criteria are listed here. Other exclusion criteria are detailed in the protocol.
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