Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

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.

Study Overview

• Status: Unknown
• Conditions: Hepatitis B, Chronic
• Intervention / Treatment: Drug: Emtricitabine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jun Cheng, M.D.; Phone Number: +86 10 84322116; Email: jun.cheng.ditan@gmail.com
• Study Contact Backup: Name: Song Yang, M.D.; Phone Number: +86 15011210692; Email: sduyangsong@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: naive child CHB group; 200 patients take generic emtricitabine capsule(200 mg one time per day) for 48 weeks	Drug: Emtricitabine; emtricitabine were given to each patients for 48 weeks; Other Names: Brand name：Huierding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
virological response rate	HBV DNA < 500 copies/ml	week 48

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBV DNA negativity rate	HBV DNA < 500 copies/ml	week 24
HBV DNA decrease level	HBV DNA decrease compared with baseline（log10 copies/ml）	week24 and 48
biochemical response	ALT normalization	week 24 and 48
HBeAg loss	HBeAg loss in HBeAg positive group	week 24 and 48
HBeAg seroconversion	HBeAg seroconversion in HBeAg positive group	week 24 and 48
HBeAg reversion	HBeAg positive in Baseline HBeAg negativie group patients	week 24 and 48
HBsAg loss	HBsAg loss	week 24 and 48
HBsAg seroconversion	HBsAg loss and anti-HBs positive	week 24 and 48
HBV genetic resistance to emtricitabine	HBV genetic resistance to emtricitabine	week 24 and 48
adverse event	type and rate of adverse events;type and rate of severe adverse event	week 24 and 48

Collaborators and Investigators

• Sponsor: Asian-Pacific Alliance of Liver Disease, Beijing
• Collaborators: Beijing Ditan Hospital; National Health and Family Planning Commission, P.R.China; Hebei Medical University Pharmaceutical Factory
• Investigators: Principal Investigator: Jun Cheng, M.D., Asian Pacific Alliance of Liver Diseases, Beijing

Publications and helpful links

General 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. doi: 10.1128/AAC.46.6.1734-1740.2002.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): July 1, 2015
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: December 23, 2014
• First Submitted That Met QC Criteria: December 29, 2014
• First Posted (Estimate): December 30, 2014

Study Record Updates

• Last Update Posted (Estimate): December 30, 2014
• Last Update Submitted That Met QC Criteria: December 29, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Child; Emtricitabine; Hepatitis B, chronic
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis B, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-HIV Agents; Anti-Retroviral Agents; Emtricitabine
• Other Study ID Numbers: FTC-01-child patients