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Efficacy and Safety of Peginterferon a-2a in Patients of Chronic Hepatitis B With Spontaneous Decline of HBV DNA

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ClinicalTrials.gov Identifier: NCT01892241
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : October 1, 2013
Sponsor:
Information provided by (Responsible Party):
Cai Qingxian, Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary:
Patients with spontaneous decline of HBV DNA were non-randomly assigned to accept peginterferon alfa-2a or entecavir therapy, or didn't accept any antiviral regiment.

Condition or disease Intervention/treatment Phase
Antiviral Treatment of Chronic Hepatitis B Drug: Pegasys(Roche) Drug: Entecavir Phase 3

Detailed Description:
It was a prospective, non-randomized, open-label study that evaluated the efficacy and safety of pegasys treatment in chronic hepatitis B patients with spontaneous HBVDNA decline after acute exacerbation.Patients with spontaneous decline of HBV DNA(a decrease of HBV DNA levels of more than 2 log(10) IU/mL as compared to baseline before antiviral treatment) after acute exacerbation (ALT was 10-30ULN,TBIL was 2-20mg/ml,PTA>60%)were non-randomly divided into 3 groups: group A, B and C. Before treatment, the patients were counselled on the advantages and disadvantages of taking peginterferon or nucleos(t)ide analogue, and the subsequential treatment were decided by themselves. Cases in group A receive 180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks. Group B and C were control group, cases in group B received an continual entecavir therapy(0.5 mg orally once daily) and those in group C didn't accept any antiviral regiment.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : January 2010
Actual Primary Completion Date : November 2012
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 180µg of peginterferon alfa-2a
Cases in group A receive 180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.
Drug: Pegasys(Roche)
180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.
Other Name: peginterferon alfa-2a

Active Comparator: Entecavir
cases in group B received an continual entecavir therapy(0.5 mg orally once daily)
Drug: Entecavir
continual entecavir therapy(0.5 mg orally once daily)

No Intervention: Control group
Those in group C didn't accept any antiviral regiment .



Primary Outcome Measures :
  1. Complete viralogic response [ Time Frame: week 96 ]
    Complete viralogic response was defined as suppression of HBV DNA to the level below 60IU/mL(detected by Cobas Amplicor HBV Monitor Test, Roche Diagnostics).


Secondary Outcome Measures :
  1. HBsAg loss and seroconversion [ Time Frame: week 24,48,72 and 96 ]
    HBsAg loss was defined as HBsAg titre less than 0.05 IU/mL and the HBsAg seroconversion was defined as the loss of HBsAg and the presence of anti-HBs antibody. HBeAg seroconversion was defined as disappearance of HBeAg and appearance of anti-HBe antibody, while HBeAg loss was defined as disappearance of HBeAg only.

  2. ALT normalization [ Time Frame: week 24,48,72 and 96 ]
    ALT normalization was defined as ALT level less than 40 IU/L(determined by a sequential multiple autoanalyzer).

  3. Sick leave in patients in different groups [ Time Frame: week 48,72 and 96 ]


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Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

This study focused on the subsequential antiviral therapeutic strategies for chronic hepatitis B patients with spontaneous decline of HBV DNA after acute exacerbation. Patients fullfilled the following criterias were chosen for screening: They were antiviral treatment naı¨ve and had been positive for hepatitis B surface antigen (HBsAg) for at least 6 months, were positive for HBeAg and had an HBV DNA Level of more than 500,000IU/ml. Their serum alanine aminotransferase level was greater than 2 but less than or equal to 30 times the upper limit of the normal range, their peak value of total bililubin ranged from 2mg/ml to 20mg/ml and the prothrombin time activity was greater than 60%.

ALL of these patients were hospitalized and pretreated with anti-inflammation and liver protection agents such as Stronger Neo-Minophagen C, Polyunsaturated phosphatidylcholine (Essentiale), Ursodeoxycholic Acid and L-Glutathione reduced, without any nuclutide of nucleoside. Their ALT、TBIL and PTA were monitor weekly and HBVDNA level were measured every two weeks. Patients were eligible if their HBVDNA declined spontaneously by 2 log(10) IU/mL while their ALT falled below 10 ULN and TBIL falled below 2mg/ml within 8 weeks of pretreatment.

Patients with advanced fibrosis, cirrhosis and hepatoma were excluded. Other cause of chronic liver disease should be systematically checked to exclude co-infection with HDV, HCV and HIV, comorbidities with alcoholism, autoimmune and metabolic liver disease. Serious medical or psychiatric illnesses that had usage of corticosteroid or immunosup-pressive agents at the time of study were excluded. All patients in this study lived in Guangdong, a province of 100,000,000 populations, with same demographics. Owing to patients fear or refusal of liver biopsy, no patients had the liver biopsy and the rest relied on other clinical methods to obtain equivalent information of patient conditions. In our cases, ultrasonorgraphy helped to filter out patients with advanced fibrosis.The liver sonar examination was performed by two experi-enced hepatologists at least three times on each patient.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01892241


Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
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Study Chair: Gao Zhiliang, doctor The Third Affliated Hospital of Sun Yat-sen University
Study Director: Zhao Zhixin, doctor The Third Affliated Hospital of Sun Yat-sen University

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Responsible Party: Cai Qingxian, Doctor, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT01892241     History of Changes
Other Study ID Numbers: ATFSHBVD
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: October 1, 2013
Last Verified: September 2013
Keywords provided by Cai Qingxian, Third Affiliated Hospital, Sun Yat-Sen University:
Chronic hepatitis B,Spontaneous Decline of HBV DNA,Peginterferon a-2a, entecavir
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Peginterferon alfa-2a
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs