Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-naïve Patients With Chronic Hepatitis B in Korea

Chronic Hepatitis B Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01776814
• Other study ID #: GAIRB2963-2012
• Status: Not yet recruiting
• Phase: N/A
• First received: January 18, 2013
• Last updated: January 25, 2013
• Start date: February 2013

Study information

• Verified date: January 2013
• Source: Gachon University Gil Medical Center
• Contact: Ju Seung Kim, Fellow
• Phone: +80+32 460 2792
• Email: joojoomj[@]gilhospital.com
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B virus infection. In this study, the investigators will try to make comparison between Entecavir and Tenofovir and investigate the efficacy.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 18 < Age < 70

• HBV DNA > 100,000 copies/mL and increased ALT over 2 times compared with normal range if HBsAg (+), HBeAg (+)

• HBV DNA > 10,000 copies/mL and increased ALT compared with normal range if HBsAg (+), HBeAg (-)

Exclusion Criteria:

• With HCV or other liver disease

• With kidney disease

• decompensated liver cirrhosis

• with hepatocellular carcinoma

• refuse this clinical trials

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center, Department of Gastroenterology	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	virologic response	Patients will check the HBV DNA level at 3, 6, 9, 12 months after taking entecavir and tenofovir	changes from baseline HBV DNA level at 3, 6, 9, 12 months after taking entecavir or tenofovir	Yes
Secondary	reduction of alanine transaminase	Patients will check the level of alanine transaminasel at 3, 6, 9, 12 months after taking entecavir and tenofovir	changes from baseline ALT level at 3,6,9,12 months after taking entecavir or tenofovir	Yes