Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection
NCT00034359 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 79
Last updated 2021-02-18
Summary
The purpose of this study was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection.
Conditions
- Hepatitis B, Chronic
Interventions
- DRUG
-
ACH-126,443
- DRUG
-
Lamivudine
- DRUG
Sponsors & Collaborators
-
Achillion, a wholly owned subsidiary of Alexion
collaborator INDUSTRY -
Alexion Pharmaceuticals, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-02-28
- Primary Completion
- 2003-01-31
- Completion
- 2003-01-31
Countries
- Bulgaria
- Federal Republic of Yugoslavia
Study Locations
More Related Trials
-
A Trial To Study The Effect Of Lamivudine In Adult Patients Who Suffer From Chronic Hepatitis B Alone
NCT00354653 ·Status: COMPLETED ·Phase: PHASE4
-
Adefovir Dipivoxil In Compensated Chronic Hepatitis B Patients
NCT00316719 ·Status: COMPLETED ·Phase: PHASE3
-
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
NCT00076336 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Telbivudine Plus Adefovir With Lamivudine Plus Adefovir for the Treatment of Lamivudine-resistant Chronic Hepatitis B at 52 Weeks: A Pilot Study
NCT01804387 ·Status: UNKNOWN ·Phase: PHASE4
-
Lamivudine Plus Adefovir Versus Telbivudine Plus Adefovir in Lamivudine Resistant Chronic Hepatitis B
NCT01270165 ·Status: UNKNOWN ·Phase: PHASE3
-
A Study to Investigate the Safety, Efficacy and Pharmacokinetic Profile of Multiple Doses of QL-007 in Chronic Hepatitis B Patients
NCT03244085 ·Status: UNKNOWN ·Phase: PHASE1
-
Lamivudine and Adefovir to Treat Chronic Hepatitis B Infection in People With and Without HIV Infection
NCT00023153 ·Status: COMPLETED ·Phase: PHASE3
-
Comparison of Telbivudine Versus Lamivudine on the Early Dynamics and Kinetics of Viral Suppression in Chronic Hepatitis B
NCT00710216 ·Status: WITHDRAWN ·Phase: PHASE4
-
Efficacy of Clevudine Plus Lamivudine for Lamivudine-resistant Chronic Hepatitis B Patients
NCT00798460 ·Status: TERMINATED ·Phase: PHASE4
-
A Randomized Controlled Trial of Lamivudine in Acute Hepatitis B
NCT00380614 ·Status: COMPLETED ·Phase: PHASE4
-
Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial
NCT00362674 ·Status: COMPLETED
-
Trial of Lamivudine Treatment in HBeAg Negative Chronic Hepatitis B Patients (in Asia)
NCT00338780 ·Status: COMPLETED ·Phase: PHASE4
-
A Phase 1 Double-Blinded Study for Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of ATI-2173 in Healthy Subjects and Subjects With Chronic Hepatitis B Virus Infection
NCT04248426 ·Status: COMPLETED ·Phase: PHASE1
-
A Safety Study to Evaluate 12 Weeks of Treatment with Clevudine in Patients Infected with Hepatitis B Virus.
NCT00044135 ·Status: UNKNOWN ·Phase: PHASE2
-
An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B
NCT00124241 ·Status: COMPLETED ·Phase: PHASE2
-
Long-Term Lamivudine Therapy for Chronic Hepatitis B
NCT00120354 ·Status: COMPLETED ·Phase: PHASE4
-
A Randomized Study Comparing Lamivudine Versus Adefovir Dipivoxil for Prevention of zHBV Reactivation in HBsAg Seropositive Patients Undergoing Cytotoxic Chemotherapy
NCT00489151 ·Status: UNKNOWN ·Phase: NA
-
Efficacy of Telbivudine Treatment at Long Term on the Absence of Liver Inflammation in Patients With Compensated Chronic Hepatitis B
NCT00877149 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Assess the Safety, Pharmacokinetics, and Antiviral Activity of ABI-H3733 in Subjects With Chronic Hepatitis B Virus Infection
NCT05414981 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
NCT00095121 ·Status: COMPLETED ·Phase: PHASE3
-
Adefovir Dipivoxil to Treat Hepatitis B in HIV-Infected Patients
NCT00013702 ·Status: COMPLETED ·Phase: PHASE2
-
An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients With Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options
NCT00042393 ·Status: APPROVED_FOR_MARKETING
-
Telbivudine Versus Lamivudine for Maintenance Therapy of Patients With Chronic Hepatitis B and Negative HBV Viral Load After 6 Month of Treatment With Telbivudine
NCT01005238 ·Status: TERMINATED ·Phase: PHASE4
-
Safety and Efficacy Study of L-FMAU in Chronic HBV Patients of L-FMAU-201 Placebo Group
NCT00313261 ·Status: TERMINATED ·Phase: PHASE2
-
Safety and Efficacy Study of LB80380 in the Patients With Lamivudine-Refractory Chronic Hepatitis B
NCT00895596 ·Status: COMPLETED ·Phase: PHASE1/PHASE2