Combination or Sequential Therapy of Peginterferon Alfa-2a and Entecavir for Patients With Chronic Hepatitis B

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Beijing 302 Hospital
Sponsor:
Information provided by (Responsible Party):
Beijing 302 Hospital
ClinicalTrials.gov Identifier:
NCT01906580
First received: May 30, 2013
Last updated: July 21, 2013
Last verified: July 2013

May 30, 2013
July 21, 2013
July 2011
July 2013   (final data collection date for primary outcome measure)
the rates of HBeAg seroconversion [ Time Frame: at week 72 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01906580 on ClinicalTrials.gov Archive Site
  • normalisation of ALT [ Time Frame: at week 2、4、12、24、36、48、60、72、84、96 ] [ Designated as safety issue: No ]
  • liver histological improvement [ Time Frame: at baseline and at week 72 ] [ Designated as safety issue: No ]
  • The rates of HBsAg negative [ Time Frame: at week12、24、36、48、60、72、84、96 ] [ Designated as safety issue: No ]
  • the rate of virological response [ Time Frame: at week 4、12、24、36、48、60、72、84、96 ] [ Designated as safety issue: No ]
  • the rate of HBeAg negative [ Time Frame: at week 12、24、36、48、60、72、84、96 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Combination or Sequential Therapy of Peginterferon Alfa-2a and Entecavir for Patients With Chronic Hepatitis B
Combination or Sequential Therapy of Peginterferon Alfa-2a and Entecavir for Hepatitis B e Antigen-positive Patients With Chronic Hepatitis B

Currently, seven medications are approved for the treatment of hepatitis B: two formulations of interferon and five nucleos(t)ide analogues. The current treatment strategy of chronic hepatitis B is now standard: initial selection of entecavir, tenofovir, or peginterferon alfa-2a (peg-IFNα-2a). Interferon is administered for a finite duration while nucleotide analogues are usually administered for many years. But among hepatitis B e antigen (HBeAg) positive patients with high serum hepatitis B virus DNA levels, the rates of virological response are poor. And antiviral drug resistance is a major limiting factor to the success of nucleotide analogue treatment. Therefore, combination therapy using peginterferon with an oral agent with a high genetic barrier to resistance might be superior to standard current monotherapy. However, the addition of lamivudine to peg-IFNα-2a therapy led to a greater decrease in serum HBV DNA levels during treatment but did not increase the rate of HBeAg sero¬conversion. Entecavir is a nucleoside analogue superior to lamivudine and adefovir in achieving higher virological response, histological improvement and normalisation of ALT. Moreover, Entecavir has a high genetic barrier with a very low incidence of drug resistance. This study is aimed to investigate the efficacy of combination or sequential therapy using peg-IFNα-2a and entecavir in HBeAg-positive chronic hepatitis B(CHB) patients.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
  • Drug: Peg-IFNα-2a
    180ug peg-IFNα-2a, subcutaneous injection per week
    Other Name: peginterferon alfa-2a
  • Drug: Entecavir
    0.5mg,oral administration every day
    Other Name: Baraclude
  • Experimental: Peg-IFNα-2a monotherapy
    Participants will receive 180ug peg-IFNα-2a therapy for 72 weeks, and then followed to 96 weeks.
    Intervention: Drug: Peg-IFNα-2a
  • Experimental: Sequential therapy
    Participants will receive entecavir monotherapy for 12 weeks, and 180ug peg-IFNα-2a therapy is added for the following 12 weeks. After that, entecavir will be stopped and 180ug peg-IFNα-2a monotherapy for the following 48 weeks. All participants will followed to 96 weeks.
    Interventions:
    • Drug: Peg-IFNα-2a
    • Drug: Entecavir
  • Experimental: Combination therapy
    Participants will receive 180ug peg-IFNα-2a combined with entecavir therapy for 72 weeks, and then followed to 96 weeks.
    Interventions:
    • Drug: Peg-IFNα-2a
    • Drug: Entecavir

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
105
July 2014
July 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age≥16 years
  2. HBsAg positive for more than 6 months, and HBeAg detection is positive for two times in 6 months before enrollment
  3. Serum HBVDNA >2×10^4IU/ml
  4. 80U/L < serum ALT < 400U/L, and TBIL < 34 umol/L
  5. Serum ALT < 80U/L, but hepatic inflammation scores ≥ G2 or hepatic fibrosis stage ≥ S3

Exclusion Criteria:

  1. Co-infected with HCV, HDV or HIV, or autoimmune liver diseases combined
  2. Hepatic decompensation
  3. received antiviral therapy or immunosuppressant drugs before 6 months prior to enrollment
  4. Blood routine examination: WBC <3×10^9/L,neutrophile granulocyte < 1.5×10^9/L,PLT <80×10^9/L
  5. Renal function: creatinine >1.5 times of upper normal limit
  6. Alcoholism or a history of addiction and abuse
  7. Combined with hepatocarcinoma
Both
16 Years to 60 Years
No
Contact: Sa Lv, MD 86-10-63879735 ext 2014.12 lvsa@sina.com
China
 
NCT01906580
2011030D
Yes
Beijing 302 Hospital
Beijing 302 Hospital
Not Provided
Principal Investigator: Fu-Sheng Wang, Professor Beijing 302 Hospital
Beijing 302 Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP