Try our beta test site
Trial record 82 of 351 for:    hepatitis b | Open Studies

The Optimizing Treatment of PegIFN Alfa in HBeAg-negative CHB Patients With Low Level HBsAg

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Collaborators:
Peking University
Huazhong University of Science and Technology
Nanchang University
Huizhou Municipal Central Hospital
First People's Hospital, Shunde China
Shenzhen Third People's Hospital
First People's Hospital of Foshan
Tang-Du Hospital
The First Affiliated Hospital of Kunming Medical College
Yuebei People's Hospital
Information provided by (Responsible Party):
Zhiliang Gao, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT02745704
First received: April 11, 2016
Last updated: August 27, 2016
Last verified: August 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 and NAs.

Condition Intervention Phase
Chronic Hepatitis B
Drug: Peginterferon alfa
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Optimizing Treatment of PegIFN Alfa in HBeAg-negative Chronic Hepatitis B Patients With Low Level HBsAg

Resource links provided by NLM:


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

Primary Outcome Measures:
  • HBsAg Clearance [ Time Frame: 72 weeks ]
    Percentage of Participants with HBsAg negative.

  • HBsAg Seroconversion [ Time Frame: 72 weeks ]
    Percentage of Participants with HBsAg negative and anti-HBsAg positive.


Estimated Enrollment: 200
Study Start Date: April 2016
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEG-IFN group
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-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks.
Drug: Peginterferon alfa
peginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week
No Intervention: NAs group
Patients do not need to change their NAs treatment.

Detailed Description:
In order to optimize HBsAg clearance in CHB patients with low level HBsAg, the investigators enrolled patients who had received, and responded to, NAs for more than 12 months(see the inclusion criteria), and patients are switched to receive peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week for 48 weeks and follow up for 24 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(Roche Cobas).

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: NCT02745704

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
Peking University
Huazhong University of Science and Technology
Nanchang University
Huizhou Municipal Central Hospital
First People's Hospital, Shunde China
Shenzhen Third People's Hospital
First People's Hospital of Foshan
Tang-Du Hospital
The First Affiliated Hospital of Kunming Medical College
Yuebei People's Hospital
  More Information

Responsible Party: Zhiliang Gao, chief director of department of infectious disease, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02745704     History of Changes
Other Study ID Numbers: 3rd-SYSU-I-Cure 
Study First Received: April 11, 2016
Last Updated: August 27, 2016
Individual Participant Data  
Plan to Share IPD: Undecided

Keywords provided by Third Affiliated Hospital, Sun Yat-Sen University:
chronic hepatitis B
peginterferon alfa

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Peginterferon alfa-2b
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 17, 2017