NCT01326546

Brief Summary

The purpose is to evaluate efficacy and safety of therapeutic hepatitis B virus (HBV) vaccine (mimogen-based)) Joint entecavir treatment in chronic hepatitis B patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
378

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2010

Typical duration for phase_2

Geographic Reach
1 country

15 active sites

Status
completed

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

June 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 31, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

June 26, 2019

Completed
Last Updated

June 26, 2019

Status Verified

March 1, 2019

Enrollment Period

3.6 years

First QC Date

March 28, 2011

Results QC Date

March 31, 2019

Last Update Submit

March 31, 2019

Conditions

Chronic Hepatitis B

Keywords

Therapeutic HBV VaccineChronic Hepatitis BHBeAg positiveHBV-specific Cytotoxic T Lymphocyte

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With HBeAg Seroconversion at Week 48

    Primary endpoint data were summarised under "End of Study",using the last available post-baseline observation(Last Observation Carried Forward,LOCF)

    48 weeks

Secondary Outcomes (4)

  • Serological Response

    96 weeks

  • Virological Response

    96 weeks

  • Biochemistry Response

    96 weeks

  • Histological Response

    72 weeks

Study Arms (2)

Therapeutic HBV vaccine+Entecavir

EXPERIMENTAL

Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.

Biological: Therapeutic HBV vaccineDrug: entecavir

placebo+Entecavir

PLACEBO COMPARATOR

Placebo comparator: Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48 and Oral intake entecavir 0.5mg per day.

Drug: entecavirOther: placebo

Interventions

Therapeutic HBV vaccineBIOLOGICAL

Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.

Also known as: εPA-44
Therapeutic HBV vaccine+Entecavir
entecavirDRUG

0.5mg,per day,oral intake.

Also known as: Baraclude
Therapeutic HBV vaccine+Entecavirplacebo+Entecavir
placeboOTHER

Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.

Also known as: empty liposome
placebo+Entecavir

Eligibility Criteria

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

You may qualify if:

  • Aged 18-65 years, male or female;
  • Conforming to diagnosis standard of chronic hepatitis B according to " 2005 Guideline for Prevention and Treatment of Hepatitis B " , (with positive HBsAg for more than 6 months), never have systemic treatment of anti-HBV viral ,and
  • HBV-DNA ≥ 1.72×10\^4 IU/ml；
  • HBeAg (+), HBeAb (-)；
  • ALT within 2 to 10 times of ULN (upper limits of normal);
  • HLA-A2 positive;
  • Compensatory liver disease having following hematological and biochemical parameters:
  • WBC ≥ 3.5×10\^9/L;
  • ANC ≥ 1.5×10\^9/L;
  • PLT ≥ 80×10\^9/L;
  • Hb ≥ 100g/L;
  • TBil ≤ 1.5 ULN;
  • ALB not lower than low limit of normal value;
  • BUN no more than high limit of normal value;
  • Cr ≤ 1.5 ULN high limit of normal value;
  • +7 more criteria

You may not qualify if:

  • Antibodies of HCV, HDV or HIV is positive;
  • ANA titer \> 1:100;
  • Decompensated liver disease (such as gullet and pylorus varicose veins, hepatic encephalopathy);
  • Have the following illness or with severe disease inappropriate to participate in the study in the view of the investigator, in cardiovascular system: instable or significant cardiovascular illness such as angina pectoris, heart attack of myocardial infarction, congestive heart failure, severe hypertension, significant arrhythmia or abnormal ECG etc;
  • Respiratory system: bronchiectasia, bronchial asthma, chronic obstructive pulmonary disease, respiratory failure, etc;
  • Endocrine, metabolism diseases: diabetes mellitus, uncontrolled thyroid diseases, etc;
  • Others: autoimmune disorder, active tuberculosis, malignancies (e.g.: tumor), neuropathic, metal, acute or chronic pancreatitis illness history, etc.
  • Have used anti-HBV drug ( Interferon, Lamivudine, Adefovir Dipivoxil, Entecavir and Telbivudine ) and immunomodulator ( Thymic peptide, etc ) to the administration of study medication;
  • Have allergic diathesis or have suspected allergy to εPA-44;
  • Female in pregnancy, lactation or those who plan to pregnancy during the course of the study;
  • Have history of alcohol abuse (Alcohol consumption for more than 5 years, with daily consumption over 40g for males and over 20g for females) and known drug dependence;
  • Have history of organ transplantation (except corneal transplantation and hair transplantation);
  • Have participated in any other drug clinical investigations within 3 months;
  • Any other factors inappropriate for enroll in the study or study completion in the view of the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

The First Affiliated of Anhui Medical University

Hefei, Anhui, China

Location

Beijing Youan Hosptial,Capital Medical University

Beijing, Beijing Municipality, China

Location

The Third People's Hosptial of Shenzhen

Shenzhen, Guangdong, China

Location

Renmin Hosptial of Wuhan University

Wuhan, Hubei, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

81th Hospital of PLA

Nanjing, Jiangsu, China

Location

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Location

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

Location

TangDu Hospital

XiAn, Shanxi, China

Location

First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310006, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

302 Militray Hosptial of China

Beijing, China

Location

Southwest Hospital

Chongqing, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

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

Results Point of Contact

Title
Dr.Wu
Organization
Institute of Immunology，PLA
wuyuzhang@yahoo.com
02368752230

Study Officials

  • LanJuan Li, Ph.D.

    Zhejiang University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2011

First Posted

March 31, 2011

Study Start

June 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 26, 2019

Results First Posted

June 26, 2019

Record last verified: 2019-03

Locations

CN(15)