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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02327676
Other study ID # FTC-01-child 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 2016

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) in Chinese naive children chronic hepatitis B patients. Single group of child patients were enrolled, which include HBeAg positive and negative Chronic hepatitis B(CHB)group.


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 in children paitients. The investigators design this trial to test the effect of FTC in Chinese children CHB which including naive HBeAg positive and Negative CHB patients.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date July 2016
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 2 Years to 17 Years
Eligibility Inclusion Criteria:

- Children with body weight = 33 kg and who can swallow entire emtricitabine capsle(200mg)

- HBsAg positive for more than 6 months

- HBeAg positive patients: HBV DNA = 5log10 copies/ml

- HBeAg positive patients: ALT=2×ULN;or liver biopsy G=2;or liver biopsy S =2;or liver biopsy Knodell HAI = 4

- HBeAg negative patients: HBV DNA = 4log10 copies/ml

- HBeAg positive patients: ALT=2×ULN;or liver biopsy G=2;or liver biopsy S =2;or liver biopsy Knodell HAI = 4

- 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

- Neutrophils <1.5E+9/L

- PLT<80E+9/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: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Emtricitabine
emtricitabine were given to each patients for 48 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 (1)

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

Outcome

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