Emtricitabine for Naive Child Chinese Chronic Hepatitis B... | NCT02327676

Studies
Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

NCT02327676

Sponsor

Asian-Pacific Alliance of Liver Disease, Beijing

Status

Unknown status

Last Update Posted

Dec 30, 2014Estimated

Enrollment

200Estimated

Phase

Phase 4

Conditions

Hepatitis B, Chronic

Interventions

Emtricitabine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Jul 2015Estimated

Completion Date

Jul 2016Estimated

First Submitted Date

Dec 23, 2014

First Submission Date that Met QC Criteria

Dec 29, 2014

First Posted Date

Dec 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 29, 2014

Last Update Posted Date

Dec 30, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jun Cheng, chaireman of Asian-Pacific Alliance of Liver Diseas,Beijing, Asian-Pacific Alliance of Liver Disease, BeijingPrincipal Investigator

Lead Sponsor

Asian-Pacific Alliance of Liver Disease, BeijingOTHER

Collaborators

Name	Class
Beijing Ditan Hospital	OTHER
Hebei Medical University Pharmaceutical Factory	INDUSTRY
National Health and Family Planning Commission, P.R.China	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
naive child CHB group	Experimental	200 patients take generic emtricitabine capsule(200 mg one time per day) for 48 weeks	Drug: Emtricitabine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Emtricitabine	Drug	emtricitabine were given to each patients for 48 weeks	naive child CHB group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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）

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jun Cheng, M.D.	Contact	+86 10 84322116		jun.cheng.ditan@gmail.com
Song Yang, M.D.	Contact	+86 15011210692		sduyangsong@163.com

Overall Officials

Name	Affiliation	Role
Jun Cheng, M.D.	Asian Pacific Alliance of Liver Diseases, Beijing	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
12019083	Background	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.

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

ID	Term
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines