Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients
Information source: Asian-Pacific Alliance of Liver Disease, Beijing
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B, Chronic
Intervention: Emtricitabine (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: Asian-Pacific Alliance of Liver Disease, Beijing Official(s) and/or principal investigator(s): Jun Cheng, M.D., Principal Investigator, Affiliation: Asian Pacific Alliance of Liver Diseases, Beijing
Overall contact: Jun Cheng, M.D., Phone: +86 10 84322116, Email: jun.cheng.ditan@gmail.com
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.
Clinical Details
Official title: Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: virological response rate
Secondary outcome: HBV DNA negativity rateHBV DNA decrease level biochemical response HBeAg loss HBeAg seroconversion HBeAg reversion HBsAg loss HBsAg seroconversion HBV genetic resistance to emtricitabine adverse event
Detailed 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.
Eligibility
Minimum age: 2 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jun Cheng, M.D., Phone: +86 10 84322116, Email: jun.cheng.ditan@gmail.com Additional Information
Related publications: 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.
Starting date: January 2015
Last updated: December 29, 2014
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