EFFicacy Optimization Research of Telbivudine Therapy

Hepatitis B, Chronic Clinical Trial

— EFFORT  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962533
• Other study ID #: MOH-01
• Status: Completed
• Phase: Phase 4
• First received: August 18, 2009
• Last updated: January 29, 2013
• Start date: August 2009
• Est. completion date: August 2012

Study information

• Verified date: March 2012
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 606
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• telbivudine
telbivudine, 600mg, oral, daily
• telbivudine
telbivudine, 600mg, oral, daily

Locations

Country	Name	City	State
China	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	First Hospital .Jilin Unniversity	ChangChun	Jilin
China	Xiangya Hospital Central-South Univrsity	ChangSha	Hunan
China	West China Hospital.SiChuan University	ChengDu	Sichuan
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	The First Affiliated Hospital of College of Medicine ,Zhejiang University	HangZhou	Zhejiang
China	The Sixth People's Hospital of Hangzhou	Hangzhou	Zhejiang
China	JiNan Infectious Diseases Hospital	JINan	Shandong
China	No.81 Hospital of PLA	NanJing	Jiangsu
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	ShengJing Hospital of China Medical University	ShenYang	Liaoning
China	Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Tangdu Hospital	XiAn	Shanxi

Sponsors (3)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Major Science and Technology Special Project of China Eleventh Five-year, Novartis

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate the percentage of patients achieving HBV DNA< 300copies/mL at Week 104 in Group I is superior than that in Group II		Week 104	No
Secondary	Percentage of patients achieving HBV DNA <60IU/mL (300copies/mL) at Week 52		week 52	No
Secondary	Serum HBV DNA reduction from baseline at week 104		week 104	No
Secondary	Percentage of patients with HBeAg loss & HBeAg seroconversion at week104 in patients with HBeAg positive at baseline		week 104	No
Secondary	Percentage of patients with HBV DNA<300copies/mL AND HBeAg loss or seroconversion at Week 104 in patients with positive HBeAg at baseline		week 104	No
Secondary	Serum HBV DNA reduction from baseline at week 52		week 52	No