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Trial record 67 of 314 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

New Strategy Study of Functional Cure of Chronic Hepatitis B

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ClinicalTrials.gov Identifier: NCT02605252
Recruitment Status : Recruiting
First Posted : November 16, 2015
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
As HBsAg clearance is uncommon in chronic hepatitis B (CHB) patients on nucleoside analogues (NAs) therapy. The purpose of this study is to optimize HBsAg clearance in CHB Patients with sequential treatment of pegylated interferon alpha-2b and NAs.

Condition or disease Intervention/treatment
Hepatitis B, Chronic Drug: Peginterferon alfa-2b

Detailed Description:
CHB Patients who had received, and responded to, NAs for more than 12 months are switched to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 48 weeks.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study on Optimizing HBsAg Clearance in CHB Patients With Sequential Treatment of Pegylated Interferon Alpha-2b and Nucleoside Analogues
Study Start Date : March 2016
Estimated Primary Completion Date : September 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: CHB patients
Hepatitis B e antigen (HBeAg)-negative CHB patients who had received NAs for more than 12 months, with HBsAg <1500 IU/ mL and Hepatitis B virus DNA not detectable, are to receive peginterferon alfa-2b 80 micrograms/week for 48 weeks.
Drug: Peginterferon alfa-2b
peginterferon alfa-2b 80 micrograms/week for 48 weeks


Outcome Measures

Primary Outcome Measures :
  1. HBsAg loss [ Time Frame: Week 48 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. CHB patients who had received NAs for more than 12 months.
  2. Hepatitis B e antigen (HBeAg)-negative and anti-HBeAg positive.
  3. Hepatitis B surface antigen (HBsAg) positive and <1500 IU/mL.
  4. Hepatitis B virus DNA not detectable.

Exclusion Criteria:

  1. Patients with liver cirrhosis, Hepatocellular Carcinoma or other malignancies.
  2. Patients with other factors causing liver diseases.
  3. Pregnant and lactating women.
  4. Patients with concomitant HIV infection or congenital immune deficiency diseases.
  5. Patients with diabetes, autoimmune diseases.
  6. Patients with important organ dysfunctions.
  7. Patients with serious complications ( e.g., infection, hepatic encephalopathy, hepatorenal syndrome, gastrointestinal bleeding. )
  8. Patients who receive antineoplastic or immunomodulatory therapy in the past 12 months.
  9. Patients who can't come back to clinic for follow-up on schedule.
Contacts and Locations

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): NCT02605252


Contacts
Contact: Xiang Zhu, Doctor +86-20-85252373 0628zhuxiang@163.com

Locations
China, Guangdong
The third affiliated hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510630
Contact: Xiang Zhu, Doctor    13826452564    0628zhuxiang@163.com   
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
Investigators
Principal Investigator: Xiang Zhu, Doctor Third Affiliated Hospital, Sun Yat-Sen University
More Information

Responsible Party: Xiang Zhu, Attending Physician, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02605252     History of Changes
Other Study ID Numbers: 3rd-sysu-hbv-functional cure
First Posted: November 16, 2015    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Xiang Zhu, Third Affiliated Hospital, Sun Yat-Sen University:
Chronic hepatitis B
Peginterferon alfa-2b
Nucleotide analogue

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Peginterferon alfa-2b
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferon-alpha
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs