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Clinical Trail of Adoptive Transfer of Immunity to HBV though Infusing with Peripheral Blood Mononuclear Cells that Collected from HBV-Immune Donor

Clinical Trail of Adoptive Transfer of Immunity to HBV though Infusing with Peripheral Blood Mononuclear Cells that Collected from HBV-Immune Donor

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-TNC-09000334
Enrollment
Unknown
Registered
2009-02-22
Start date
2008-01-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis B

Interventions

Single group:Donor: to enhance immunity by recombinant HBsAg hepatitis B vaccine and arouse marrow by granulocyte colony-stimulating factor (GC-SF) before peripheral blood mononuclear cells (PBMC) acq

Sponsors

Southwest Hospital, Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: Recipients: 18-45years; chronic hepatitis B patients with HBsAg/HBeAg/HBcAb positive; serum alanine aminotransferase (ALT) level during 2-10 folds upper limits of normal, and serum total bilirubin normal; have no other viruses and bacterial infections, such as HAV, HCV, HDV, HEV, HIV, CMV, EBV, HSV, tubercle bacillus and treponema pallidum; No serious cardiovascular, renal, hematological, endocrine, neurological, respiratory and other vital organs disease and mental illness; without fertility requirements the next 2 to 3 years; Voluntary subjects and sign informed consent form.Donors: healthy, without chronic diseases; HBsAb/HBcAb positive or HBsAb/HBeAb/HBcAb positive; No long-term medication history; Voluntary to accept hepatitis B vaccine and PBMC collection, and sign informed consent.

Exclusion criteria

Exclusion criteria: Pregnant or lactating women; any use of immunosuppressant drugs within 6 months; suspicious or confirmed cirrhosis; have mental illness or epilepsy history; with severe cardiovascular, renal, hematological, endocrine, neurological, respiratory diseases or other vital organs diseases; malignant disease in the past 5 years; immunologic disease history and / or anti-nuclear antibody (ANA)> 1:160; long history of exposure to hepatotoxicity substances, such as alcoholism or drug addiction; any of co-infection with HAV, HCV, HDV, HEV, EBV, CMV, HSV or HIV, etc.; organ transplant history; Premonitory symptoms of acute infectious disease; participated in any other clinical trials within 3 months; compliance poor, who should not complete the course

Design outcomes

Primary

MeasureTime frame
Serum HBsAg, anti-HBs, HBeAg, anti-HBe and anti-HBc;

Secondary

MeasureTime frame
Serum HBV DNA level;Serum ALT, AST levels;

Countries

China

Contacts

Public ContactDeng Guohong
ghdengsnp@hotmail.com+86 023 68754141

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026