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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02327689
Other study ID # FTC-01-cirrhosis patients
Secondary ID
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


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
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