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Trial record 154 of 309 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

"Treatment of Active HBV With γδT Cells" Clinical Trial Protocol

This study is not yet open for participant recruitment.
Verified April 2017 by Zhinan Yin, Ph.D., Jinan University Guangzhou
Sponsor:
ClinicalTrials.gov Identifier:
NCT03113058
First Posted: April 13, 2017
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Guagnzhou Qiaokang Hospital
Information provided by (Responsible Party):
Zhinan Yin, Ph.D., Jinan University Guangzhou
  Purpose
To evaluate the safety and anti-HBV efficacy of γδT cells.

Condition Intervention Phase
Adoptive Treatment for Hepatitis B With γδT Cells Combination Product: Adoptive transfer of γδT cells Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "Treatment of HBeAg-positive Chronic Hepatitis B With γδT Cells" Clinical Trial Protocol

Resource links provided by NLM:


Further study details as provided by Zhinan Yin, Ph.D., Jinan University Guangzhou:

Primary Outcome Measures:
  • DNA copy number [ Time Frame: 6 months ]
    Whether or not the DNA copy number in patients can be lowered more faster than those do not received T cell treatment in 6 months.

  • Negative conversion rate of HbeAg [ Time Frame: 6 months ]
    We will evaluate whether or not γδT Cells treatment could speed up Negative conversion rate of HbeAg.


Estimated Enrollment: 60
Anticipated Study Start Date: May 2, 2017
Estimated Study Completion Date: November 1, 2018
Estimated Primary Completion Date: October 5, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: study group Combination Product: Adoptive transfer of γδT cells
Patients are treated via intravenous infusion of in vitro-activated allogeneic γδ Tcells every two weeks, 12 times in total (6 months).

Detailed Description:
In this clinical trial, we will thoroughly evaluate the safety of in vitro expanded γδT cells, including allogeneic originated γδT cells, in clinical treatment of active HBV. At the same time, we will carefully and thoroughly examine and evaluate the clinical efficacy of γδT cells against active HBV, including lowering speed of DNA copy number, and the transferring rate of HBeAg from positive to negative.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1. Aged 18-45 years old, male or female; 2. Informed consent; 3. Patient who were tested HBsAg and HBeAg positive; 4. HBV DNA loads>1 million copy/ml;5. Liver function test alanine aminotransferase (ALT) 160 IU/L≤400 IU/L; 6. No jaundice, total bilirubin is normal;7. For patients with new onset, oral antiviral drugs limited for Sebivo.

Exclusion Criteria:

  • 1. Pregnant women;2. Patients Complicated with other viruses, bacteria infections and other infectious diseases;3. With other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system disease, mental illness, neurological disease, vascular circulation system diseases and so on, and after clinical doctors diagnose, evaluate the immune cells are not suitable for treatment of patients;4. There is no immediate relatives, immediate family members suffering from infectious diseases including e antigen positive, or immediate family is not suitable for patients as white blood cells supplier;5. Other indications that is not suitable for the treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113058


Contacts
Contact: Zhinan Yin, Ph.D. (+86)18818801179 zhinan.yin@yale.edu
Contact: Yangzhe Wu, Ph.D. (+86)18826469480 190374157@qq.com

Locations
China, Guangdong
Guagnzhou Qiaokang Hospital Not yet recruiting
Guangzhou, Guangdong, China
Contact: Ren X Lai, bachelor    +86-15920368701    huitou_2007@163.com   
Sponsors and Collaborators
Jinan University Guangzhou
Guagnzhou Qiaokang Hospital
  More Information

Responsible Party: Zhinan Yin, Ph.D., Principal Investigator, Jinan University Guangzhou
ClinicalTrials.gov Identifier: NCT03113058     History of Changes
Other Study ID Numbers: GDT-HBV-01-QK
First Submitted: April 10, 2017
First Posted: April 13, 2017
Last Update Posted: April 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhinan Yin, Ph.D., Jinan University Guangzhou:
HBV infection,γδT cells,Adoptive treatment

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human