Ancillary study on a sub-population of the chronic hepatitis B patients enrolled in the TH HBV VV-001 study to investigate the potential shedding of ChAd155-hIi-HBV after intramuscular administratio

Phase 1

• Conditions: Chronic hepatitis B; MedDRA version: 20.1Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2017-002574-39-DE
• Lead Sponsor: GlaxoSmithKline Biologicals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-20
• Last Update Posted: 21 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

•Patients who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
•Written informed consent obtained from the patient prior to performance of any study specific procedure.
•Patients who met all inclusion criteria and were randomised to the Step B of the TH HBV VV-001 study.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 38

Exclusion Criteria

Patients met any exclusion criterion of the TH HBV VV-001 study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified