A Clinical Study on Therapeutic Double-plasmid Hepatitis B Virus (HBV) DNA Vaccine in Patients With HBeAg-positive Chronic Hepatitis B

NCT01189656 | Unknown Phase 2 DMC

• 1 other identifier: 71007.02
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To preliminarily evaluate the efficiency and safety of therapeutic double- plasmid HBV DNA vaccine on HBeAg-positive, chronic hepatitis B patients, and provide evidence for the next dosing regimen.

Conditions

Chronic Hepatitis B Patients With HBeAg-positive

Keywords

Chronic hepatitis B patients

Outcome Measures

Primary Outcomes (1)

• The change of HBV DNA load at Week 72

  72 weeks

Secondary Outcomes (8)

• The rate of subjects with HBV DNA titer reducing > 2 logarithms .

  Every 12 weeks

• The change of HBeAg and HBsAg titer.

  Every 12 weeks

• The change of ALT.

  Every 12 weeks

• HBsAg/HBeAg serum conversion rate.

  Every 12 weeks

• The INF-gamma expression level in peripheral blood mononuclear cells (PBMC).

  Every 12 weeks

Study Arms (2)

Vaccine+Lamivudine group

EXPERIMENTAL

Subjects assigned into the experimental and the controlled groups with randomization and double-blindness by a ratio of 2:1

Biological: HBV DNA Vaccine

Placebo+Lamivudine group

PLACEBO COMPARATOR

Biological: HBV DNA Vaccine

Interventions

HBV DNA Vaccine BIOLOGICAL

HBV DNA Vaccine, 1mg/ml/syringe, formulation

Also known as: Therapeutic Double-plasmid HBV DNA Vaccine

Placebo+Lamivudine group; Vaccine+Lamivudine group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The following conditions must be met for all enrolled subjects:
• Aged 18-65 years with either sex;
• HBV serology meet the following criteria:
• HBsAg-positive lasting for at least 6 months at the time of screening;
• HBeAg-positive at the time of screening;
• Serum HBV DNA≥1.0×10E5 copies/ml at the time of screening
• U/L\<ALT\<400U/L;
• TBIL\<40μmol/L;
• No YMDD mutation of the HBV drug resistance gene
• Subjects agree not to participate in any other clinical trial or take any other anti-HBV therapeutics during the study;
• Subjects understand and sign the ICF which approved by EC, and are able to comply with the study procedures and complete the study.

You may not qualify if:

• Subjects meeting the following conditions will not be enrolled in the study:
• Was suspected with HCC by the following evidence:
• B-Ultrasound or imaging which shows occupying lesions;
• Continuingly elevating serum AFP level even if the B-Ultrasound is normal;
• AFP \>100ng/ml;
• With acute hepatic decompensation caused by liver disease aggravation or with clinical symptoms of decompensated liver disease at baseline;
• Serum Cr≥1.5mg/dl (≥130μmol/l) at the time of screening;
• Serum amylase \> two-fold of the upper limit of the normal reference value;
• Hb (male\<100g/ L, female\<90g/L), WBC\<3.5×10E9/L,PLT\<60×10E9/L (except hypersplenism and cirrhosis);
• Co-infection with HCV (anti-HCV positive), HIV and anti-HAV IgM positive, anti-HDV IgM positive, anti-HEV IgM positive, anti-CMV IgM positive and autoimmune hepatitis (e.g. antinuclear antibody titer\>1:160 ) or other active liver disease caused by known or unknown factors;
• Any other serious disease or active diseases other than hepatitis B that are considered by investigators to be potential factors that may interfere with the therapy, assessment or compliance with the protocol, including any uncontrolled diseases with clinical significance, e.g. kidney, heart, lung, blood vessel, neurogenic, digestive system and metabolic diseases (diabetes, hyperthyroidism, adrenal gland diseases), autoimmune dysfunctions, and tumors, etc;
• History of alcohol or drug abuse that is considered by investigators that could affect subject's compliance with the protocol or could influence the result of the analysis;
• Pregnant or breast-feeding female subjects, or those who plan to be pregnant during the course of the study or male subjects' companions who plan to be pregnant during the course of the study;
• Having used immunosuppressive agents, immunomodulators (thymosin), cytotoxic drugs within 6 months or transaminase-decreasing drugs within one month prior to the initiation of this study;
• Having used anti-HBV drugs (Lamivudine, interferon, adefovir, entecavir, or sebivo, etc.) within 6 months prior to the initiation of this study;

Sponsors & Collaborators

• The 458 Hospital of Chinese PLA: lead
• Guangzhou Baidi Biotechnology Co., Ltd: collaborator
• Guangzhou Pharmaceucal Company Limited: collaborator

Study Sites (1)

Department of Infections Disease of Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Study Officials

• Yu Yanyan, Professor

  SFDA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 25, 2010
• First Posted: August 27, 2010
• Study Start: January 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 27, 2010

Record last verified: 2009-02

Locations

CN (1)