Lamivudine has been approved in the United States and in the European Union and in the Other Countries

Studies listed may include approved and non-approved uses, formulations or treatment regimens. Before prescribing any product mentioned in this Register, healthcare Professionals should consult prescribing information approved in their country (view UK and US information for Healthcare Professionals).

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lamivudine studies

Select the study ID number to view the trial summary

Study IDPhaseTitle
105698 IV A post-marketing surveillance to monitor the safety of Zeffix(Lamivudine) administered in Korean chronic hepatitis B virus infection subjects according to the prescribing information
EPV40001 IV Open-Label, Pilot Study To Explore The Early Antiviral Activity And Tolerability Of Abacavir And Epivir When Each Is Administered Once-Daily Within A Triple Combination Regimen Including Abacavir, Epivir And Retrovir Compared to The Triple Combination Regimen Administered Twice-Daily In Antiretroviral Naïve, HIV-1 Infected Subjects (48 Week Report).
KOREA105816 IV A post-marketing surveillance to monitor the safety of 3TCTM (Lamivudine 150mg) administered in Korean subjects according to the prescribing information
LAMPOL 4001 IV Multicentre, open study to determine the effect of Lamivudine on HBV DNA clearance and to assess the safety of the regimen in patients with chronic hepatitis B infection
LAMPOL 4003 IV Open study to determine the effect of Lamivudine on liver histology and DNA HBV suppression in patients after seroconversion in HBeAg and with HBsAg present
LAMPOL4002 IV A multicentre, open study to estimate the effect of Lamivudine on liver histology and HBV DNA clearance in patients with chronic hepatitis B
NUC30925 IV An open-label, Phase-IV study to demonstrate the efficacy and safety of locally manufactured (Suzhou, China) Lamivudine tablets (100mg) in Chinese patients with chronic hepatitis B (CHB)
NUC30937 IV An open label one year study of lamivudine in patients with chronic hepatitis.
NUC30944 IV A study of the safety and efficacy of Lamivudine 100 mg QD in patients with HBeAg negative (presumed pre-core mutant) chronic hepatitis B virus infection.
NUC30956 IV An Open Study of Lamivudine Treatment in Adult HBeAg Negative (presumed pre-core mutant) Chronic Hepatitis B genotype D Patients in Iran.
NUC40019 IV An open study to determine the safety and efficacy of lamivudine in subjects with chronic hepatitis B
NUC40021 IV A Stratified, Partially Randomised (Stratum B only), Double Blind, Multicentre Trial of Lamivudine and Adefovir Dipivoxil Treatment for Patients with Chronic Hepatitis B Who Have Shown Disease Progression by Reaching a Clinical Endpoint
NUC40032 IV Pre-emptive Lamivudine and Chemotherapy-induced Hepatitis B Virus Reactivation in Patients with Hematologic Malignancies
NUC40036 IV An open-label, Phase IV study to examine whether the duration of lamivudine treatment following HBeAg seroconversion affects the durability of the HBeAg seroconversion response in Asian patients.
NUC40040 IV An Extended, Observational Study in Pediatric Patients with Chronic Hepatitis B Who Have Previously Received Long-Term Lamivudine Treatment
WE066, EPI40007 IV The Antiretroviral Pregnancy Registry (APR, Registry)
WE490 IV Lactic acid levels in children prenatally and perinatally treated with antiretrovirals to prevent HIV transmission.
ADF30003 III Clinical Evaluation of Adefovir Dipivoxil (GW284873X) in Patients with chronic hepatitis B (including cirrhosis B) who have signs of clinical deterioration associated with the replication of YMDD variant HBV following lamivudine therapy – A follow-up long term study of ADF30002 (a 16 week open label study).
LAM-EG-18 (NUC30933) III A Study of the Safety and Efficacy of Lamivudine 100 mg OD in Egyptian Patients with Chronic Replicating Hepatitis B Virus (CHB).
LB-02 III Phase III Study of Lamivudine - A Placebo-controlled, Double-blind Study of Lamivudine in Chronic Hepatitis B Patients - (Protocol No: LB-02)
LB-03 III Phase III Study of Lamivudine - A Long-term Study of Lamivudine in Chronic Hepatitis B Patients - (Protocol No: LB-03)
LB-04 III Phase III Clinical Trial of GG714 (Lamivudine): Histological Evaluation of Long-term Treatment - A Full Report of Extension Study - (Protocol No. LB-04)
LB-06 III Phase III Study of Lamivudine - Follow-up Investigation after Double-blind Study (LB-02) and Long-term Study (LB-03) - (Protocol No.: LB-06)
NUC30902 III A multicenter, prospective, descriptive study to compare the efficacy of lamivudine alone versus lamivudine plus anti-HB hyperimmune gammaglobulin in the prevention of hepatitis B virus reinfection after liver transplant.
NUC30903 III A Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of 52 Weeks Lamivudine Treatment at a Dose of 3 mg/kg in Paediatric Subjects with Chronic Hepatitis B
NUC30907 III A randomized, double-blind, placebo-controlled study of the treatment of HBsAg positive patients after stable renal transplantation with lamivudine
NUC30914 III A multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of recombinant HBV vaccine and hepatitis B immunoglobulin (HBIg) plus lamivudine versus recombinant HBV vaccine and HBlg plus placebo for the prevention of mother-to-child transmission of HBV.
NUC30926 III An Extended, Stratified Follow-on Study In Paediatric Subjects With Chronic Hepatitis B Who Have Completed Previous Lamivudine Studies
NUC30928 (NUCPT01) III A multicentre, single-arm, non-randomised trial to evaluate the efficacy and safety of lamivudine 100mg once a day in patients with chronic hepatitis B virus infection.
NUC30935 III A Randomised, Multicenter, Placebo-Controlled Study to Assess the Efficacy and Optimal Duration of Lamivudine Treatment in Patients with Pre-core Mutant HBV
NUC30958 (714LC-02) III A Phase III Clinical Study of GG714 (Lamivudine) Tablet -A study of extended GG714 treatment for subjects with hepatitis B-related Cirrhosis (long-term study)
NUC40040 III An Extended, Observational Study in Pediatric Patients with Chronic Hepatitis B Who Have Previously Received Long-Term Lamivudine Treatment
NUCA/B3016 III A Five Year Final Study Report for NUCA/B3016 - A Long-Term Epidemiologic Study of Subjects Who Have Evidence of Possible Durable Response to Lamivudine in Phase II or Phase III Trials of Lamivudine
NUCA2010/LAM-COMP III Lamivudine Compassionate Use for Patients with Decompensated Liver Injury Secondary to Hepatitis B Infection
NUCA3002 III A Randomized 3TCTM, ddC Double-Blind (ZDV Open-labeled) Multi-center Trial to Evaluate the Safety and Efficacy of 3TCTM (low dose) Administered Concurrently with Zidovudine (ZDV) versus 3TCTM (high dose) Administered Concurrently with ZDV Versus Dideoxycytidine (ddC) Administered Concurrently with ZDV in the Treatment of HIV-1 Infected ZDV-experienced (?24 Weeks) Patients with CD4 Cell Counts of 100/mm3 to 300/mm3.
NUCA3010 III A Study of Lamiviudine or Placebo in Patients with Chronic Hepatitis B Infection Who are Treatment Naive
NUCA3021 III Lamivudine Compassionate Use Treatment Program for Subjects with Three Life-Threatening Forms of Hepatitis B Infection
NUCAB3011 III A Placebo Controlled Study of Lamivudine and Intron A® in Patients with Chronic Hepatitis B Infection Who are Interferon a Non-Responders
NUCAB3017 III A Study of Extended Lamivudine Treatment for Hepatitis B Subjects Previously Enrolled in Phase II or Phase III Lamivudine Trials
NUCB2015 III A Study of the Immunobiology of Patients with Chronic Hepatitis B Infection Treated with Lamivudine. Extensive searching has revealed that no clinical study report is available for this study. The Clinical trial results were reported via publication; see citation below.
NUCB3001 III A Randomized, Controlled 3TCTM Double-Blinded Trial to Compare the Safety and Efficacy of 3TCTM in Combination with Zidovudine (ZDV) Versus Zidovudine Monotherapy in Treating HIV-1 Infected Patients Who Are Zidovudine Therapy-Naïve With a CD4 Cell Count Between 100 - 400 cells/mm3.
NUCB3002 III A Randomized, Controlled, Lamivudine (3TCTM) Double-Blinded Trial to Compare the Safety and Efficacy of Zidovudine (ZDV) Monotherapy Versus Lamivudine Plus ZDV in Combination in Treating HIV-1 Infected Patients who are Zidovudine Therapy-Experienced With a CD4+ Cell Count Between 100cells/mm3 to 400cells/mm3
NUCB3007 III A Randomized, Controlled, Double-Blinded, Clinical End-Point Trial to Compare the Efficacy and Safety of 3TC Versus 3TC + Loviride Versus Placebo in the Treatment of HIV-1 Infected Persons Taking Concurrent Zidovudine-Containing Treatment Regimens With CD4 Counts Between 25cells/mm3 to 250cells/mm3
NUCB3009 III A Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Two Dosage Regimens of Lamivudine in Patients with Chronic Hepatitis B Infection
NUCB3010 III A Study of Lamivudine and Alpha-Interferon in Patients with Chronic Hepatitis B Infection Who are Interferon Treatment Naive
NUCB3014 III A Study of Lamivudine in Patients With HBeAb Positive Chronic Hepatitis B Infection; Week 52 (End of Treatment) Analysis
NUCB3018 III A Follow-On Study to Determine the Safety and Efficacy of Long-Term Lamivudine Treatment in Patients with Chronic Hepatitis B Infection (5 Year Treatment Plus 6 Months Off-treatment Follow-Up)
NUCB3026 III A Double-Blind, Placebo-Controlled Study Of Lamivudine In Subjects In China With Chronic Hepatitis B Infection Followed By Long-Term (5 Years) Lamivudine Treatment
NUCB4006 III A Double-blind Placebo Controlled Clinical End-points Trial of Lamivudine in Patients with Hepatitis B Related Cirrhosis
ZEFT01 III A double blind randomised multicentre study of lamivudine added to the current treatment in the therapy of chronic hepatitis B in HBV-DNA/anti-HBe positive Subjects.
ZEFT02 III Open-label study of lamivudine in combination with interferon in treating chronic hepatitis B, anti HBe positive patients who are interferon-therapy naïve.
ZEFT03 III Open label treatment with lamivudine in patients with chronic hepatitis B, Anti HBe (Hepatitis B envelope) Positive, who have not responded to previous treatment with interferon. Study of lamivudine added to the interferon treatment in comparison to the sequential treatment
COLA4005 II A Phase II, Open-Label, Randomized Study of the Efficacy and Safety of EPIVIR 150mg Twice-Daily Versus EPIVIR 300mg Once-Daily When Administered for 24 Weeks in Combination with FDA-Approved Dosage Regimens of ZERIT and Either CRIXIVAN or VIRACEPT in Subjects with HIV-1 Infection
EPV20001 II A Phase II/III 48-Week, Randomized, Double-Blind, Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Lamivudine 300mg QD vs Lamivudine 150mg BID in Combination with Zidovudine 300mg BID and Efavirenz 600mg QD in Antiretroviral-Naïve Adults with HIV-1 Infection. 48-Week Report
LB-01 II Dose Finding Study on Lamivudine in Chronic Hepatitis B Patients (Protocol LB01)
M00026/012 II An open, randomised, multicentre, phase II study to evaluate the safety and therapeutic efficacy of an investigational vaccination regimen versus Lamivudine in adult patients with HBeAg positive chronic Hepatitis B. Lamivudine (Lam): GlaxoSmithKline (GSK) Biologicals’ cytosine nucleoside analogue with anti-HIV and anti-hepatitis B activity. HBeAg: hepatitis B e antigen; HIV: human immunodeficiency virus.
NUC20904 II A randomised, stratified, double-blind, multicentre study of the safety and efficacy of 52 weeks treatment with adefovir dipivoxil and lamivudine for subjects with chronic hepatitis B who have developed hepatitis B virus variants and evidence of reduced therapeutic response to lamivudine
NUC20905 II A Multicentre, Double-blind, Randomised, Placebo-controlled Pilot Study to Evaluate the Effect of Lamivudine on Serum HDV RNA in Subjects Co-infected with Hepatitis B and Delta Virus
NUC20912 II A Phase II Study of Lamivudine Compared to Lamivudine Plus Adefovir Dipivoxil for Subjects With Chronic Hepatitis B
NUC20917 II A double-blind, active-controlled, randomized 52-week extended follow-on study to investigate the long-term efficacy and safety of adefovir dipivoxil 10mg and lamivudine 100mg treatment for subjects with hepatitis B who have completed the previous Phase II protocol NUC20904
NUC30910 II Lamivudine for Prevention of HBV Reactivation in HBsAg Seropositive Patients undergoing Cytotoxic Chemotherapy
NUCA2005 II A phase I/II study to evaluate the safety, toxicity and preliminary efficacy of combinations of lamivudine (3TC), Zidovudine (ZDV) and Didanosine (ddI) in children with HIV infection.
NUCA2006 II A Pilot Study to Assess the Safety and Efficacy of Lamivudine During the Course of Liver Transplantation for Patients with Chronic Hepatitis B Infection
NUCA2008 II A Continuation Study of Lamivudine in Patients with Chronic Hepatitis B Infection
NUCA3001 II A Randomized, Double-Blind, Multi-center Trial to Compare the Safety and Efficacy of 3TCTM Monotherapy Versus Zidovudine (ZDV) Monotherapy Versus 3TCTM Administered Concurrently with ZDV in the Treatment of HIV-1 Infected Patients who are ZDV-Naïve (=4 weeks) with CD4 Cell Counts of 200-500 cells/mm3
NUCA3005 II Lamivudine Open-label Protocol for Treatment of Patients with Hepatitis B Viral Infection After Liver Transplantation
NUCB2001 II A phase I/II study of the safety, pharmacokinetics and preliminary activity of 3TC (GR109714X) in HIV-positive, asymptomatic and mild ARC patients.
NUCB2002 II A Randomized, Multicentre, Single-blind (Patient), Placebo-controlled, Phase II, Dose-ranging Study to Determine the Pharmacokinetics, Safety and Preliminary Activity of Once Daily Lamivudine in Patients with Chronic Hepatitis B Infection
NUCB2003 II A Randomized, Multicentre, Single Blind (Patient) Study to Compare the Efficacy and Safety of 25 mg, 100 mg, and 300 mg Lamivudine, Once daily in patients with Chronic Hepatitis B Infection
NUCB2004 II A Randomized, Phase II, Single-blind (Patient), Placebo-controlled, Dose-ranging Study to Determine the Safety and Preliminary Activity of Lamivudine in Oriental Patients with Chronic Hepatitis B Infection
NUCB2005 II A Randomised, Phase II, Single-blind (Patient) Placebo-controlled, Dose-ranging Study to Determine the Safety and Preliminary Activity of Lamivudine in Oriental Patients with Chronic Hepatitis B Infection
NUCB2007 II A Double-blind, Placebo-controlled, Randomised, Parallel Group, Multicentre Study to Assess the Effect of Lamivudine on the Safety, Tolerability and Pharmacokinetics of Alpha-interferon in Patients Receiving Interferon for Chronic Hepatitis B Infection
NUCB2008 II An Open, Multicentre Study to Determine the Safety, Pharmacokinetics and Preliminary Efficacy of Lamivudine in Chronic Hepatitis B Patients in End Stage Liver Failure Undergoing Liver Transplantation
NUCB2010 II An Open Phase II Pilot Study to Determine the Safety and Activity of Lamivudine in Patients with Chronic Hepatitis C Infection
NUCB2013 II An Open, Randomised, Multicentre Study to Compare the Safety and Efficacy of Lamivudine Versus Hepatitis B Immunoglobulin in the Prevention of Hepatitis B Reinfection After Liver Transplantation
NUCB2014 II Multicentre, Open Label Compassionate Use Programme for Patients Treated with 100 mg Lamivudine Once Daily for up to 5 Years
NUCB2018 II The Pharmacokinetics of Epivir (Lamivudine) When Co-Administered With Retrovir (Zidovudine) to HIV-1 Infected Pregnant Women and Their Offspring
NUCB2020 II A Phase II, Dose Ranging Study of the Pharmacokinetics of Lamivudine in Children and Adolescents with Chronic Hepatitis B Virus Infection
NUCB2021 II An Open, Single Centre Study to Determine the Safety, Pharmacokinetics and Preliminary Efficacy of Lamivudine in Chronic Hepatitis B Patients in End Stage Liver Failure (ESLF) Undergoing Liver Transplantation
C93-015 I A Study to Investigate the Pharmacokinetics of Lamivudine (GR109714X) in Patients with Impaired Hepatic Function
EPV10001 I An Open-Label, Randomized, 2-way Cross-over Study to Compare the Steady-State Pharmacokinetics of Lamivudine and Lamivudine Triphosphate Following Lamivudine 300mg Once Daily Versus EPIVIR 150mg Twice a Day in Healthy Volunteers
LB-05 I Comparison of Pharmacokinetic of Lamivudine Between Elderly Volunteers and Healthy Young Male Volunteers (Protocol LB-05)
M00026/016 I An open, randomised, multicentre, phase I/II study to evaluate the safety and therapeutic efficacy of an investigational vaccination regimen versus Lamivudine, in adult patients with HBeAg negative, anti-HBe antibody positive chronic Hepatitis B. Lamivudine (Lam): GlaxoSmithKline (GSK) Biologicals’ cytosine nucleoside analogue with anti-HIV and anti-hepatitis B virus (anti-HBV) activity. HBeAg: hepatitis B e antigen; HIV: human immunodeficiency virus.
NUC10901 I An Open Label Study of the Pharmacokinetics of Lamivudine (GR109714X) in Subjects Receiving Peritoneal Dialysis in Endstage Renal Failure
NUC10902 I A randomized, open-label, cross-over study in Chinese healthy subjects, to establish bioequivalence between two formulations of Lamivudine (GR109714X) clinical trail material
NUC10905 I A randomised, open label, cross-over study in Chinese healthy subjects, to establish bioequivalence between lamivudine oral solution and tablet (GR109714X) clinical trial material.
NUCA1004 I A Single-Dose Study of GR109714X (3TCTM) in HIV-Infected Patients with Impaired Renal Function
NUCA1006 I Bioequivalence of Lamivudine [GR109714X, 3TCTM] 75mg, 100mg, and 300mg Tablets in Asymptomatic HIV-Infected Male Patients
NUCA2002 I A Phase I/II Study of 3TC (GR109714X) in Children With HIV Infection
NUCB1002 I A Study to Investigate the Pharmacokinetics of Lamivudine (GR109714X) in Patients With Impaired Hepatic Function (Protocol No: C93-015)
NUCB1003 I A Study to Investigate the Pharmacokinetics of Lamivudine (GR109714X) Following Oral Dosing in Subjects With Impaired Renal Function
NUCB1004 (C93-086) I A study to investigate the comparative bioavailability of two oral formulations of GR109714X (Lamivudine).
NUCB1007 I A Study to Investigate the Pharmacokinetic Interaction Between Lamivudine and Alpha-Interferon in Healthy Subjects
NUCB1009 I A study to investigate the pharmacokinetics of lamivudine (GR109714X) in healthy male and female Chinese subjects.