Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

NCT02327676 | Unknown Phase 4 DMC

• 1 other identifier: FTC-01-child patients
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis B, Chronic

Keywords

Hepatitis B, chronic; Emtricitabine; Child

Outcome Measures

Primary Outcomes (1)

• virological response rate

  HBV DNA \< 500 copies/ml

  week 48

Secondary Outcomes (10)

• HBV DNA negativity rate

  week 24

• HBV DNA decrease level

  week24 and 48

• biochemical response

  week 24 and 48

• HBeAg loss

  week 24 and 48

• HBeAg seroconversion

  week 24 and 48

Study Arms (1)

naive child CHB group

EXPERIMENTAL

200 patients take generic emtricitabine capsule(200 mg one time per day) for 48 weeks

Drug: Emtricitabine

Interventions

Emtricitabine DRUG

emtricitabine were given to each patients for 48 weeks

Also known as: Brand name：Huierding

naive child CHB group

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Asian-Pacific Alliance of Liver Disease, Beijing: lead
• Beijing Ditan Hospital: collaborator
• Hebei Medical University Pharmaceutical Factory: collaborator
• National Health and Family Planning Commission, P.R.China: collaborator

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

  PMID: 12019083 BACKGROUND

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Emtricitabine

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jun Cheng, M.D.

  Asian Pacific Alliance of Liver Diseases, Beijing

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Cheng, M.D.

CONTACT

+86 10 84322116; jun.cheng.ditan@gmail.com

Song Yang, M.D.

CONTACT

+86 15011210692; sduyangsong@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chaireman of Asian-Pacific Alliance of Liver Diseas,Beijing

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: December 30, 2014
• Study Start: January 1, 2015
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2016
• Last Updated: December 30, 2014

Record last verified: 2014-12