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Trial record 66 of 362 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

New Strategy Study of Functional Cure of Chronic Hepatitis B

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2016 by Xiang Zhu, Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Information provided by (Responsible Party):
Xiang Zhu, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT02605252
First received: November 8, 2015
Last updated: September 19, 2016
Last verified: September 2016
  Purpose
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 Intervention
Hepatitis B, Chronic Drug: Peginterferon alfa-2b

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Xiang Zhu, Third Affiliated Hospital, Sun Yat-Sen University:

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

Estimated Enrollment: 120
Study Start Date: March 2016
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
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: 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
Study First Received: November 8, 2015
Last Updated: September 19, 2016
Individual Participant Data  
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

ClinicalTrials.gov processed this record on June 22, 2017