A Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Adults With Compensated Chronic Hepatitis B

Conditions

Chronic Hepatitis B

Brief summary

This study is being conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) with 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.

Shen S, Liang X, Hamed K, Tanaka Y, Omagari K, Fan R, Xie Q, Tan D, Zhou B, Jia JD, Hou J, Sun J.

2017-06-0611 citations

10.1111/hepr.12907

Long-Term Telbivudine Treatment Results in Resolution of Liver Inflammation and Fibrosis in Patients with Chronic Hepatitis B

Jinlin Hou, Daozheng Xu, Guangfeng Shi, Mobin Wan, Zachary Goodman et al. (18 authors)

Advances in Therapy2015-08-0122 citations

10.1007/s12325-015-0232-2

52-week efficacy and safety of telbivudine with conditional tenofovir intensification at week 24 in HBeAg-positive chronic hepatitis B.

Piratvisuth T, Komolmit P, Tanwandee T, Sukeepaisarnjaroen W, Chan HL, Pessôa MG, Fassio E, Ono SK, Bessone F, Daruich J, Zeuzem S, Cheinquer H, Pathan R, Dong Y, Trylesinski A.

2013-02-0428 citations

10.1371/journal.pone.0054279

Telbivudine versus lamivudine in patients with chronic hepatitis B.

Lai CL, Gane E, Liaw YF, Hsu CW, Thongsawat S, Wang Y, Chen Y, Heathcote EJ, Rasenack J, Bzowej N, Naoumov NV, Di Bisceglie AM, Zeuzem S, Moon YM, Goodman Z, Chao G, Constance BF, Brown NA, Globe Study Group.

2007-12-01525 citations

10.1056/nejmoa066422

Interventions

DRUGtelbivudine or lamivudine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

16 Years to 70 Years

Inclusion criteria

* Chronic Hepatitis B, documented by Clinical history compatible with chronic HBV Other protocol-defined inclusion criteria may apply.

Exclusion criteria

* Patient is pregnant or breastfeeding * Patient is co infected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV-1 or HIV-2. * Patient previously received lamivudine or an investigational anti-HBV nucleoside or nucleotide analog at any time * Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study Other protocol defined

Design outcomes

Primary

Measure	Time frame
Primary efficacy endpoint: therapeutic response, defined as reduction of serum HBV DNA to below 5 log10 copies/mL, coupled with normalization of serum alanine aminotransferase levels OR loss of detectable serum HBeAg.	—

Secondary

Measure	Time frame
Secondary efficacy endpoints: Improvement of liver histology, serum HBV DNA changes, normalization of serum alanine aminotransferase levels, HBeAg and HBsAg loss and seroconversion.	—

Countries

South Korea, Spain, Thailand, Turkey (Türkiye), United Kingdom, United States

Outcome results

None listed