Optimization of Antiviral Therapy of Chronic HBV Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LiangXS, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT01623778
First received: June 16, 2012
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

Along with the improvement of the accuracy of detection of HBV serological markers, the optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection becomes feasible. Currently, the recommendation of optimized treatment especially interferon therapy are mainly based on retrospective studies, it still lacks prospective evidence. This study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg positive CHB with inadequate response to 24 weeks interferon treatment.


Condition Intervention
Australia Antigen Positive
Hepatitis B
Adverse Effects
Drug: Interferon Alfa-2a add on ADV

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observation Study of Different Optimized Therapy Method of Patients With Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • HBeAg seroconversion rate [ Time Frame: 48weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • HBV DNA decline [ Time Frame: 48weeks ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood samples were retented at 12w,24w and 48w after optimized therapy


Enrollment: 67
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Add on ADV
Patients with inadequate response to interferon at 24 weeks received interferon add on ADV optimized therapy
Drug: Interferon Alfa-2a add on ADV
Interferon add on ADV for 48 weeks
Other Names:
  • Response guild treatment
  • optimized therapy
  • Chronic HBV infection
Switch to LDT
Patients with inadequate response to interferon at 24 weeks received switching to LDT therapy
Drug: Interferon Alfa-2a add on ADV
Interferon add on ADV for 48 weeks
Other Names:
  • Response guild treatment
  • optimized therapy
  • Chronic HBV infection

Detailed Description:

Patients with inadequate response to interferon therapy at 24 weeks were enrolled in this study and accepted the optimized therapy (add on ADV or switch to LDT) for 48weeks. All these patients were followed for 48 weeks and the HBeAg seroconversion and HBV DNA level were observed. Safety and the economic effect of the two optimized therapy methods also were observed.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

cases of HBeAg-positive CHB with inadequate response to 24 weeks Peg interferon alpha-2a were enrolled.

Criteria

Inclusion Criteria:

patients receiving Peg interferon α-2a with inadequate response at 24 weeks (HBeAg titer ≥ 100Paul Ehrlich Institute Unit (PEIU)/ml and HBV DNA ≥ 5.0 Log copies/ml or HBV DNA titer decline <1 Log copies/ml) were enrolled into this study.

Exclusion Criteria:

  • no decompensated cirrhosis,
  • no hepatitis C, hepatitis D or human immunodeficiency virus (HIV) co-infection,
  • no hepatocellular carcinoma and other tumors or history of severe hepatitis,
  • no other systems diseases, such as a history of cardiopulmonary diseases, thyroid disorders, immune system disorders, epilepsy or mental illness (such as severe depression).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01623778

Locations
China, Shanghai
Changhai hospital
Shanghai, Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Investigators
Study Director: Wan Mo Bin, Dr Changhai Hospital affiliated to the Second Military Medical University
  More Information

No publications provided

Responsible Party: LiangXS, Assistant Professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT01623778     History of Changes
Other Study ID Numbers: HBV2012
Study First Received: June 16, 2012
Last Updated: June 19, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Changhai Hospital:
HBeAg seroconversion
Peginterferon alfa-2a
chronic hepatitis B(CHB
Optimal therapy
Response guild treatment(RGT);

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferon-alpha
Interferons
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 14, 2014