Cirrhosis Clinical Trial
Official title:
Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine.
Multicenter, multinational, randomized, double-blind study designed to compare the safety and efficacy of telbivudine (600 mg/day) versus lamivudine (100 mg/day) for 104 weeks in adults with decompensated chronic hepatitis B and evidence of cirrhosis. Patients were pre-stratified by screening Child-Turcotte-Pugh score (CTP score < 9 or ≥ 9) and ALT level (within normal limits (WNL) or > 1.0 x ULN) to help assure similar degrees of hepatic insufficiency and liver inflammation on both treatment arms. After 104 weeks of treatment, participants were followed-up with for an additional 16 weeks. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01884415 -
Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis
|
Phase 3 | |
Recruiting |
NCT05014594 -
Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT
|
Phase 2 | |
Not yet recruiting |
NCT03631147 -
The Effect of Rifaximin on Portal Vein Thrombosis
|
N/A | |
Completed |
NCT04939350 -
Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
|
||
Completed |
NCT02528760 -
To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis
|
N/A | |
Recruiting |
NCT05484206 -
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
|
Phase 1 | |
Not yet recruiting |
NCT05538546 -
Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
|
||
Not yet recruiting |
NCT04053231 -
Hepatocarcinoma Recurrence on the Liver Study - Part2
|
||
Recruiting |
NCT02983968 -
Use of the French Healthcare Insurance Database
|
||
Completed |
NCT02705534 -
Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1
|
Phase 3 | |
Completed |
NCT02596880 -
Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics
|
Phase 3 | |
Completed |
NCT02247414 -
Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection
|
Phase 4 | |
Completed |
NCT02016196 -
Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS
|
Phase 3 | |
Withdrawn |
NCT01956864 -
Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer
|
Phase 1 | |
Completed |
NCT02113631 -
Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir
|
N/A | |
Completed |
NCT01362855 -
Advance Care Planning Evaluation in Hospitalized Elderly Patients
|
||
Completed |
NCT01447537 -
Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis
|
N/A | |
Active, not recruiting |
NCT01205074 -
¹³C-Methacetin Breath Test (MBT) Methodology Study
|
Phase 2/Phase 3 | |
Completed |
NCT01476995 -
Prognostic Indicators as Provided by the EPIC ClearView
|
N/A | |
Completed |
NCT01231828 -
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.
|
N/A |