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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01906580
Other study ID # 2011030D
Secondary ID
Status Recruiting
Phase Phase 4
First received May 30, 2013
Last updated August 14, 2015
Start date July 2011
Est. completion date July 2016

Study information

Verified date August 2015
Source Beijing 302 Hospital
Contact Sa Lv, MD
Phone 86-10-63879735
Email lvsa@sina.com
Is FDA regulated No
Health authority China: Ministry of Health
Study type Interventional

Clinical Trial Summary

Currently, seven medications are approved for the treatment of hepatitis B: two formulations of interferon and five nucleons(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.


Recruitment information / eligibility

Status Recruiting
Enrollment 105
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Peg-IFNa-2a
180ug peg-IFNa-2a, subcutaneous injection per week
Entecavir
0.5mg,oral administration every day

Locations

Country Name City State
China Research Center for Biological Therapy, The Institute of Translational Hepatology, Beijing 302 Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Ayoub WS, Keeffe EB. Review article: current antiviral therapy of chronic hepatitis B. Aliment Pharmacol Ther. 2011 Nov;34(10):1145-58. doi: 10.1111/j.1365-2036.2011.04869.x. Epub 2011 Oct 7. Review. — View Citation

Kuo A, Gish R. Chronic hepatitis B infection. Clin Liver Dis. 2012 May;16(2):347-69. doi: 10.1016/j.cld.2012.03.003. Review. — View Citation

Kwon H, Lok AS. Hepatitis B therapy. Nat Rev Gastroenterol Hepatol. 2011 May;8(5):275-84. doi: 10.1038/nrgastro.2011.33. Epub 2011 Mar 22. Review. — View Citation

Rehermann B, Nascimbeni M. Immunology of hepatitis B virus and hepatitis C virus infection. Nat Rev Immunol. 2005 Mar;5(3):215-29. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the rates of HBeAg seroconversion at week 72 No
Secondary normalisation of ALT at week 2?4?12?24?36?48?60?72?84?96 No
Secondary liver histological improvement at baseline and at week 72 No
Secondary The rates of HBsAg negative at week12?24?36?48?60?72?84?96 No
Secondary the rate of virological response at week 4?12?24?36?48?60?72?84?96 No
Secondary the rate of HBeAg negative at week 12?24?36?48?60?72?84?96 No
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