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Safety and Tolerability of TG1050: A Dose-finding Study

NCT02428400 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2018-11-27

No results posted yet for this study

Summary

Methodology:

This is a double-blind, randomized, placebo-controlled, multi-cohort Phase 1/1b study in patients that are currently being treated for chronic HBV infection. For all cohorts, patients must be receiving antiviral treatment with either tenofovir disoproxil fumarate (TDF) or entecavir (ENT) for at least two years, and have their HBV infection well-controlled

Conditions

Interventions

BIOLOGICAL

TG1050

TG1050: adenovirus serotype 5 vector based immunotherapeutic product in adenovirus reference material (ARM) buffer

BIOLOGICAL

Placebo

Placebo: adenovirus reference material (ARM) buffer

Sponsors & Collaborators

  • Transgene

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2018-11-30
Completion
2018-11-30

Countries

  • Canada
  • France
  • Germany

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02428400 on ClinicalTrials.gov