Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery.

Study Overview

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

Detailed Description

Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery, which include HBeAg positive and negative 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• HBsAg positive for more than 6 months
• HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml
• HBeAg postive 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 postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
• Nucleoside/nucleotide naive patients
• Diagnosed as ≥ 12 weeks pregnancy

Exclusion Criteria:

• Diagnosed HCC with AFP and ultrasound, CT or MRI
• Creatine >130μmol/L or Ccr < 70mL/min
• Hemoglobin <100g/L
• Coinfected with HAV,HEV,HCV,HDV or HIV
• ANA > 1:100
• Uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer
• Drug abuse or alcohal 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
• Family history of genetic defects disease
• Abnormal results in fatal defects screening
• HBsAg positive sperm provider pregnancy

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: Chinese naive pregnant chronice hepatitis B; Chinese naive pregnant chronice hepatitis B were enrolled to take emtricitabine (200 mg one time per day) till 48 weeks after delivery.	Drug: Emtricitabine; emtricitabine were given to each patients at baseline till 48 weeks after delivery; 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 after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HBV DNA decrease level	HBV DNA decrease compared with baseline（log10 copies/ml）	week 24 and 48 after delivery
virological response rate	HBV DNA < 500 copies/ml	week 24 after delivery
biochemical response	ALT normalization	week 24 and 48 after delivery
HBeAg loss	HBeAg loss in HBeAg positive group	week 24 and 48 after delivery
HBeAg seroconversion	HBeAg seroconversion in HBeAg positive group	week 24 and 48 after delivery
HBeAg reversion	HBeAg positive in Baseline HBeAg negativie group patients	week 24 and 48 after delivery
HBsAg loss	HBsAg loss	week 24 and 48 after delivery
HBsAg seroconversion	HBsAg loss and anti-HBs positive	week 24 and 48 after delivery
HBV genetic resistance to emtricitabine	HBV genetic resistance to emtricitabine	week 24 and 48 after delivery
adverse event	type and rate of adverse events;type and rate of severe adverse event;	week 24 and 48 after delivery
birth defect in newborns	birth defect in newborns	0 weeks, week24 and week48 after delivery
HBsAg positive rate in newborns	HBsAg positive rate in newborns	0 weeks, week24 and week48 after delivery

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

• Lim SG, Ng TM, Kung N, Krastev Z, Volfova M, Husa P, Lee SS, Chan S, Shiffman ML, Washington MK, Rigney A, Anderson J, Mondou E, Snow A, Sorbel J, Guan R, Rousseau F; Emtricitabine FTCB-301 Study Group. A double-blind placebo-controlled study of emtricitabine in chronic hepatitis B. Arch Intern Med. 2006 Jan 9;166(1):49-56. doi: 10.1001/archinte.166.1.49.
• 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, 2017

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: Pregnancy; 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-02-pregnant CHB patients