Efficacy of Peginterferon Alpha 2a Therapy in Chronic Hepatitis B Patients Being Treated With Nucleoside(Acid) Analogues

NCT02362490 | Unknown Phase 4

• 1 other identifier: DTXY004
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Antiviral therapy is the most important method to slow and stop the progress of the disease in patients with chronic hepatitis B (CHB). Nucleoside (acid) analogues (NA) can Effectively suppress HBV replication, but it should be continue used and relapse would happen in most patients after withdrawal of therapy. However, long-term use of NA could induce viral resistance mutation lead to loss of efficacy. Interferon treatment can enhance specific and non-specific immune function in chronic hepatitis B patients, make patients get immune control to HBV infection and obtain sustained response after treatment. Thus the CHB patients on the treatment of NA should be stop NA treatment after interferon treatment. In this study, the effects of interferon treatment in CHB patients who were on the NA treatment and obtained HBsAg level≤250 IU/ml.

Conditions

Chronic Hepatitis B

Keywords

chronic hepatitis B; interferon; Nucleotide analogues; HBsAg

Outcome Measures

Primary Outcomes (1)

• rate of HBsAg loss

  the effects of peginterferon alpha 2a will be evaluated by HBsAg loss defined as HBsAg level lower than 0.05 IU/ml after 72 week treatment,compared control group.

  72 weeks

Secondary Outcomes (1)

• decline of HBsAg level

  72 weeks

Study Arms (2)

peginterferon alpha 2a

EXPERIMENTAL

in this group, patients who were on treatment of Nucleoside (Acid) Analogues and had achieved HBsAg level ≤250 IU/ml will switch to treatment of peginterferon alpha 2a for 72 week.

Drug: peginterferon alpha 2a

control group

NO INTERVENTION

in this group, patients who were on treatment of Nucleoside(Acid) Analogues and had achieved HBsAg level ≤250 IU/ml will be continue to treatment of Nucleoside(Acid) Analogues for 72 week.

Interventions

peginterferon alpha 2a DRUG

in this group,patients will receive 180 ug of peginterferon alpha 2a injection weekly for 72 weeks

Also known as: PEG-IFN a-2a

peginterferon alpha 2a

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patients who were chronic hepatitis B and had achieved HBsAg level ≤250 IU/ml on treatment of Nucleoside (acid) Analogues

You may not qualify if:

• Active consumption of alcohol and/or drugs
• Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
• History of autoimmune hepatitis
• Psychiatric disease
• Evidence of neoplastic diseases of the liver

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Beijing Ditan hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yao Xie, MD

CONTACT

8610-84322489; xieyao00120184@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: liver diseases center

Study Record Dates

• First Submitted: February 9, 2015
• First Posted: February 13, 2015
• Study Start: January 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: September 13, 2016

Record last verified: 2016-08

Locations

CN (1)