Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

Pregnancy Clinical Trial

Official title:

Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02327702
• Other study ID #: FTC-02-pregnant CHB patients
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 23, 2014
• Last updated: December 29, 2014
• Start date: January 2015
• Est. completion date: July 2017

Study information

• Verified date: December 2014
• Source: Asian-Pacific Alliance of Liver Disease, Beijing
• Contact: Jun Cheng, M.D.
• Phone: +86 10 84322116
• Email: jun.cheng.ditan[@]gmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery, which include HBeAg positive and negative patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 2017
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Pregnancy

Intervention

Drug:
• Emtricitabine
emtricitabine were given to each patients at baseline till 48 weeks after delivery

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Asian-Pacific Alliance of Liver Disease, Beijing	Beijing Ditan Hospital, Hebei Medical University Pharmaceutical Factory, National Health and Family Planning Commission, P.R.China

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	virological response rate	HBV DNA < 500 copies/ml	week 48 after delivery	No
Secondary	HBV DNA decrease level	HBV DNA decrease compared with baseline(log10 copies/ml)	week 24 and 48 after delivery	No
Secondary	virological response rate	HBV DNA < 500 copies/ml	week 24 after delivery	No
Secondary	biochemical response	ALT normalization	week 24 and 48 after delivery	No
Secondary	HBeAg loss	HBeAg loss in HBeAg positive group	week 24 and 48 after delivery	No
Secondary	HBeAg seroconversion	HBeAg seroconversion in HBeAg positive group	week 24 and 48 after delivery	No
Secondary	HBeAg reversion	HBeAg positive in Baseline HBeAg negativie group patients	week 24 and 48 after delivery	No
Secondary	HBsAg loss	HBsAg loss	week 24 and 48 after delivery	No
Secondary	HBsAg seroconversion	HBsAg loss and anti-HBs positive	week 24 and 48 after delivery	No
Secondary	HBV genetic resistance to emtricitabine	HBV genetic resistance to emtricitabine	week 24 and 48 after delivery	No
Secondary	adverse event	type and rate of adverse events;type and rate of severe adverse event;	week 24 and 48 after delivery	Yes
Secondary	birth defect in newborns	birth defect in newborns	0 weeks, week24 and week48 after delivery	Yes
Secondary	HBsAg positive rate in newborns	HBsAg positive rate in newborns	0 weeks, week24 and week48 after delivery	No