NCT01464281

Brief Summary

A Randomized, open-label, multicenter study. The patients after 1-3 years NAs treatment and having achieved HBeAg loss and HBV DNA \<200IU/ml will be switched to Pegasys for 48 or 96 weeks (with a 12 weeks period of overlap with the NA for safety reasons). The subjects will be randomized into 2 groups: Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week. All the patients will be followed up for 48 weeks after discontinuation of the study medication. Note: NAs will be stratified LAM, ETV and ADV, with the ratio 1:1:1.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

October 19, 2011

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 3, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 3, 2011

Status Verified

November 1, 2011

Enrollment Period

4.7 years

First QC Date

October 19, 2011

Last Update Submit

November 1, 2011

Conditions

Chronic Hepatitis B

Keywords

nucleosidepeginterferon alfa-2a

Outcome Measures

Primary Outcomes (1)

  • determine the response rate (HBsAg clearance at Week 48 and 96)

    To determine the response rate (HBsAg clearance at Week 48 and 96) in subjects who are being treated by NAs and achieved a combined response which consists of both HBeAg loss and HBV DNA \<1000 copies/ml

    1 year

Secondary Outcomes (1)

  • HBsAg/HBeAg/HBV DNA changes/ALT normalization /HBsAg seroconversion at EOT and EOF

    1 year

Study Arms (2)

48-week standard treatment

EXPERIMENTAL

48-week standard treatment by Peginterferon alfa 2a 180µg/week

Drug: Peginterferon alfa 2a

96-week prolonged treatment

ACTIVE COMPARATOR

96-week prolonged treatment by Peginterferon alfa 2a 180µg/week

Drug: Peginterferon alfa 2a

Interventions

Peginterferon alfa 2aDRUG

Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week.

48-week standard treatment96-week prolonged treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients on-treatment with NAs (ADV, ETV or LAM) for 1-3 years, having achieved HBeAg loss at screening, and HBV DNA \<200IU/ml for at least 48 weeks
  • Male and female patients ≥ 18 to 65 years of age
  • Chronic hepatitis B (positive HBsAg for at least 6 months prior to NA therapy start)
  • Compensated liver disease (Child-Pugh \<6)
  • Absence of hepatocellular carcinoma on liver imaging and/or alfa fetoprotein \< 50 ng/ml
  • Negative urine or blood pregnancy test for women of childbearing potential within 24 hours of first PEG IFN study medication administration
  • Able and willing to provide informed consent and abide by the requirements of the study

You may not qualify if:

  • Neutrophil count \<1.5 x 109cells/L or platelet count \<90 x 109cells/L
  • Co-infections with HIV, HAV, HCV, HDV or HEV
  • Women with ongoing pregnancy or breast feeding, or wishing to become pregnant during the study period
  • Prolonged and excessive alcohol intake (\> 40g/day for men and \> 30g/day for women)
  • Active intravenous drug abuse
  • History or current treatment with telbivudine
  • Treatment with immunomodulators (e.g. Interferon) for less than one year before study enrollment
  • Treatment with immunosuppressors (including systemic corticosteroids) or anti-neoplastic treatment (including radiation therapy) \<=6 months prior to the first dose of study drug or the expectation that such treatment will be needed at any time during the study
  • Serum concentrations of ceruloplasmin or alfa-antitrypsin consistent with an increased risk of metabolic disease
  • History or other evidence of chronic pulmonary disease associated with functional limitation
  • History of severe cardiac disease
  • History of the severe seizure disorder or current anticonvulsivant use
  • History of thyroid disease poorly controlled on prescribed medications. Patients with elevated thyroid stimulating hormone concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
  • History or other evidence of severe retinopathy
  • History of autoimmune disease or presence of a significant level of auto-antibodies
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 2nd affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Related Publications (2)

  • Hu P, Shang J, Zhang WH, Gong GZ, Li YG, Chen XY, Jiang JN, Xie Q, Dou XG, Sun YT, Li YF, Liu YX, Liu GZ, Ma DW, Chi XL, Tang H, Li XO, Xie Y, Chen XP, Jiang JJ, Zha P, Hou JL, Gao ZL, Fan HM, Ding JG, Zhang DZ, Ren H. [HBsAg loss with Pegylated-interferon alfa-2a in hepatitis B patients with partial response to nucleos(t)-ide analog: new switch study]. Zhonghua Gan Zang Bing Za Zhi. 2018 Oct 20;26(10):756-764. doi: 10.3760/cma.j.issn.1007-3418.2018.10.005. Chinese.

    PMID: 30481882DERIVED

  • Hu P, Shang J, Zhang W, Gong G, Li Y, Chen X, Jiang J, Xie Q, Dou X, Sun Y, Li Y, Liu Y, Liu G, Mao D, Chi X, Tang H, Li X, Xie Y, Chen X, Jiang J, Zhao P, Hou J, Gao Z, Fan H, Ding J, Zhang D, Ren H. HBsAg Loss with Peg-interferon Alfa-2a in Hepatitis B Patients with Partial Response to Nucleos(t)ide Analog: New Switch Study. J Clin Transl Hepatol. 2018 Mar 28;6(1):25-34. doi: 10.14218/JCTH.2017.00072. Epub 2018 Mar 17.

    PMID: 29577029DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hong Ren

    The 2nd affiliated Hospital of Chongqing Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 19, 2011

First Posted

November 3, 2011

Study Start

October 1, 2011

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

November 3, 2011

Record last verified: 2011-11

Locations

CN(1)