DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



EFFicacy Optimization Research of Telbivudine Therapy

Information source: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B, Chronic

Intervention: telbivudine (Drug); telbivudine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Nanfang Hospital of Southern Medical University

Official(s) and/or principal investigator(s):
Jinlin Hou, MD, Principal Investigator, Affiliation: Nanfang Hospital of Southern Medical University

Summary

The purpose of this trial is to prove that the strategy of treatment adjustment at W24 according to virological response based on ROADMAP concept is better than standard of care strategy.

Clinical Details

Official title: A Two-year, Randomized, Controlled, Open-label, Virologic Response Adaptive Design, Multicenter Study to Optimize Antiviral Efficacy of Telbivudine in Adult Patients With HBeAg Positive Chronic Hepatitis B (EFFORT Study)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II

Secondary outcome:

Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52

Serum HBV DNA reduction from baseline at week 104

Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline

Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline

Serum HBV DNA reduction from baseline at week 52

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female, from 18 (inclusive) to 65 (inclusive) years of age

- HBsAg and HBeAg positive for over six months

- Patient is willing and able to comply with the study drug regimen and all other study

requirements

- Patients must give written informed consent before any assessment is performed

Exclusion Criteria:

- Detected M204I/V, N236T, A181V/T mutation in patient serum HBV DNA at Screening visit

- Patient has a history of or clinical signs/symptoms of hepatic decompensation

- Patient has a history of hepatocellular carcinoma (HCC) or findings suggestive of

possible HCC

- Other protocol-defined inclusion/exclusion criteria may apply

Locations and Contacts

302 Military Hospital of China, BeiJing, Beijing, China

Beijing Ditan Hospita, Beijing, Beijing, China

Beijing Friendship Hospital Attached to the Capital Medical University, Beijing, Beijing, China

BeiJing YouAn Hospital ,Capital Medical University, BeiJing, Beijing, China

Department of infectious disease, First Hospital of Peking University, Beijing, Beijing, China

People'S Hospital Under Beijnig University, Beijing, Beijing, China

The Second Affiliated of ChongQing University of Medical Science, ChongQing, Chongqing, China

Department of infectious disease, Nanfang Hospital, Guangzhou, Guangdong, China

No. 8 People's Hospital In GuangZhou, GuangZhou, Guangdong, China

The Third Hospital of Sun Yat-Sen University, GuangZhou, Guangdong, China

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China

Xiangya Hospital Central-South Univrsity, ChangSha, Hunan, China

No.81 Hospital of PLA, NanJing, Jiangsu, China

First Hospital .Jilin Unniversity, ChangChun, Jilin, China

ShengJing Hospital of China Medical University, ShenYang, Liaoning, China

JiNan Infectious Diseases Hospital, JINan, Shandong, China

Changhai Hospital affiliated to Second Military Medical University, ShangHai, Shanghai, China

Huashan Hospital,Fudan University, ShangHai, Shanghai, China

No.85 Hospital of PLA, ShangHai, Shanghai, China

Shanghai Ruijin Hospital, ShangHai, Shanghai, China

Tangdu Hospital, XiAn, Shanxi, China

West China Hospital.SiChuan University, ChengDu, Sichuan, China

The First Affiliated Hospital of College of Medicine ,Zhejiang University, HangZhou, Zhejiang, China

The Sixth People's Hospital of Hangzhou, Hangzhou, Zhejiang, China

Additional Information

Related publications:

Keeffe EB, Zeuzem S, Koff RS, Dieterich DT, Esteban-Mur R, Gane EJ, Jacobson IM, Lim SG, Naoumov N, Marcellin P, Piratvisuth T, Zoulim F. Report of an international workshop: Roadmap for management of patients receiving oral therapy for chronic hepatitis B. Clin Gastroenterol Hepatol. 2007 Aug;5(8):890-7. Epub 2007 Jul 13. Review.

Starting date: August 2009
Last updated: January 29, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017