Clinical Trials Logo
  1. Home
  2. Chronic Hepatitis B
  3. NCT02355951
  4. Details
NCT02355951 Clinical Trial

Non-investigational Study to Evaluate Adenovirus Serotype 5 (Ad5) Neutralizing Antibodies (nAb) in Patients With Chronic Hepatitis B Virus (HBV) Mono-infection

Chronic Hepatitis B Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02355951
Other study ID # TG1050.01
Secondary ID
Status Completed
Phase N/A
First received January 21, 2015
Last updated February 1, 2016
Start date December 2014
Est. completion date February 2016

Study information
Verified date February 2016
Source Transgene
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial Summary

Objectives:

Primary Objective:

To identify and preselect patients with chronic HBV mono infection, who are undetectable for anti-Ad5 nAb, currently being treated with nucleo(t)sides, for participation in the TG1050.02 Phase1/1b First in Man (FIM) study.

Secondary Objectives:

To assess the prevalence of undetectable anti-Ad5 nAb in chronic HBV mono-infected patients.

Methodology:

Patients with chronic HBV mono-infection, who are currently being treated with nucleo(t)sides for their HBV infection, will be enrolled in this study to measure Ad5 nAb levels. A single peripheral blood collection (4 mL) will be obtained and Ad5 nAb titers will be measured by a central laboratory using a newly validated assay.

Recruitment information / eligibility
Status Completed
Enrollment 166
Est. completion date February 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- 18 through 65 years of age, inclusive

- Patients mono-infected with HBV and currently on HBV treatment for at least 2 years with either the nucleos(t)ide tenofovir (TDF) or entecavir (ENT)

- HBV DNA < lower limit of quantification (LLOQ) (eg, HBV deoxyribonucleic acid (DNA) < 20 IU/mL using the Roche COBAS TaqMan assay) within 6 last months

- Signed, written Independent Ethics Committee (IEC)-approved informed consent

Exclusion Criteria:

- Patients with either medical history or evidence of cirrhosis, as documented in the medical source, who had: a) any biopsy showing cirrhosis; or b) any transient elastography score of = 10.5 kPa or Fibrosure® / FibroTest ® score of = 0.48 with either test result within past 2 years.

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

Intervention

Other:
• blood draw

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Transgene

Countries where clinical trial is conducted

Canada,  France,  Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Immunology analysis: Serum titers of Adenovirus serotypes 5 (Ad5) neutralizing antibodies (nAb) Day 1 No
See also
  Status Clinical Trial Phase
Recruiting NCT04496882 - Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue Phase 4
Completed NCT04083716 - A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults Phase 1
Not yet recruiting NCT03038802 - A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection Phase 1/Phase 2
Completed NCT05310487 - Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects Phase 1
Recruiting NCT06070051 - Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy Phase 1
Terminated NCT05001022 - A Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Doses in Healthy Volunteers and Multiple Doses in CHB Subjects Phase 1
Recruiting NCT04139850 - The Establishment of Korean Hepatitis B Patients Cohort
Recruiting NCT05343481 - Efficacy of VTP-300 in Chronic Hepatitis B Infection Phase 2
Not yet recruiting NCT05490836 - Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients N/A
Recruiting NCT04543565 - Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study Phase 3
Active, not recruiting NCT02894918 - A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs Phase 4
Not yet recruiting NCT02793791 - Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients N/A
Recruiting NCT02287857 - Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B N/A
Recruiting NCT01965418 - A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial Phase 4
Recruiting NCT01491295 - Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients Phase 4
Terminated NCT01872988 - Tenofovir Antiviral Therapy Following Transarterial Chemoembolization for HBV Related Hepatocellular Carcinoma Phase 3
Recruiting NCT01487876 - Efficacy and Safety of Dual-plasmid Hepatitis B Virus DNA Vaccine in Chronic Hepatitis B Patients Phase 2
Completed NCT01531166 - A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon N/A
Not yet recruiting NCT01436539 - Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients Phase 4
Recruiting NCT01360892 - Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography N/A