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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 rate

HBV 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

Page last updated: August 20, 2015

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