Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients

Hepatitis B, Chronic Clinical Trial

Official title:

Emtricitabine Plus Adefovir Dipivoxil for Naive Chinese HBV Related Cirrhosis Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02327689
• Other study ID #: FTC-01-cirrhosis patients
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 23, 2014
• Last updated: December 29, 2014
• Start date: January 2015
• Est. completion date: July 2017

Study information

• Verified date: December 2014
• Source: Asian-Pacific Alliance of Liver Disease, Beijing
• Contact: Jun Cheng, M.D.
• Phone: +86 10 84322116
• Email: jun.cheng.ditan[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

This study evaluates generic emtricitabine(FTC) plus adefovir dipivoxil in Chinese naive HBV related cirrhosis patients. Patients were divided into 2 groups: compensated HBV related cirrhosis patients and decompensated HBV related cirrhosis patients.

Description:

Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent plus adefovir dipivoxil in cirrhosis patients. The investigators design this trial to test the effect of FTC plus adefovir dipivoxil in Chinese naive compensated and decompensated HBV related cirrhosis patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: July 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Dignosed cirrhosis patients

• HBsAg positive for more than 6 months

• HBV DNA detectable

• Nucleoside/nucleotide naive patients

Exclusion Criteria:

• Diagnosed HCC with AFP and ultrasound, CT or MRI

• Creatine >130µmol/L or Ccr < 70mL/min

• Hemoglobin <100g/L

• Coinfected with HAV,HEV,HCV,HDV or HIV

• ANA > 1:100

• Uncontrolled cardiovascular diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer;

• Drug abuse or alcohol addiction

• Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine

• Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial

• Underwent liver transplantation or liver transplantation in schedule

• Allergic to nucleoside or nucleotide analogues

• Pregnancy or in breastfeeding

Study Design

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

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• Emtricitabine plus adefovir dipivoxil
emtricitabine plus adefovir dipivoxil were given to each patients for 96 weeks

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Asian-Pacific Alliance of Liver Disease, Beijing	Beijing Ditan Hospital, Hebei Medical University Pharmaceutical Factory, National Health and Family Planning Commission, P.R.China

References & Publications (2)

Gish RG, Leung NW, Wright TL, Trinh H, Lang W, Kessler HA, Fang L, Wang LH, Delehanty J, Rigney A, Mondou E, Snow A, Rousseau F. Dose range study of pharmacokinetics, safety, and preliminary antiviral activity of emtricitabine in adults with hepatitis B virus infection. Antimicrob Agents Chemother. 2002 Jun;46(6):1734-40. — View Citation

Lim SG, Ng TM, Kung N, Krastev Z, Volfova M, Husa P, Lee SS, Chan S, Shiffman ML, Washington MK, Rigney A, Anderson J, Mondou E, Snow A, Sorbel J, Guan R, Rousseau F; Emtricitabine FTCB-301 Study Group. A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B. Arch Intern Med. 2006 Jan 9;166(1):49-56. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	virological response rate	HBV DNA < 500 copies/ml	week 96	No
Secondary	HBV DNA negativity rate	HBV DNA < 500 copies/ml	week 24, 48 and 72	No
Secondary	HBV DNA decrease level	HBV DNA decrease compared with baseline(log10 copies/ml)	week24, 48, 72 and 96	No
Secondary	biochemical response	ALT normalization	week 24,48,72 and 96	No
Secondary	HBeAg loss	HBeAg loss in HBeAg positive group	week 24,48,72 and 96	No
Secondary	HBeAg seroconversion	HBeAg seroconversion in HBeAg positive group	week 24,48,72 and 96	No
Secondary	HBeAg reversion	HBeAg positive in Baseline HBeAg negativie group patients	week 24,48,72 and 96	No
Secondary	HBsAg loss	HBsAg loss in both group	week 24,48,72 and 96	No
Secondary	HBsAg seroconversion	HBsAg loss and anti-HBs positive	week 24,48,72 and 96	No
Secondary	HBV genetic resistance to emtricitabine and adefovir	HBV genetic resistance to emtricitabine and adefovir	week 24,48,72 and 96	No
Secondary	adverse event	type and rate of adverse events;type and rate of severe adverse event	week 24,48,72 and 96	Yes
Secondary	incidence of HCC	incidence of HCC in both groups	week 24,48,72 and 96	No
Secondary	change of MELD score and Child-Pugh score	change of MELD score and Child-Pugh score in both groups	week 24,48,72 and 96	No