Trials / Completed
CompletedNCT02428400
Safety and Tolerability of TG1050: A Dose-finding Study
A Phase I/IB Randomized, Double-blind, Placebo Controlled, Dose-finding Study to Evaluate Safety, Tolerability of TG1050 Single/Multiple Doses, and Evaluation of TG1050 Immunologic/Antiviral Activity in Patients With Chronic Hep B Infection
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Transgene · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | TG1050 | TG1050: adenovirus serotype 5 vector based immunotherapeutic product in adenovirus reference material (ARM) buffer |
| BIOLOGICAL | Placebo | Placebo: adenovirus reference material (ARM) buffer |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2018-11-01
- Completion
- 2018-11-01
- First posted
- 2015-04-28
- Last updated
- 2018-11-27
Locations
12 sites across 3 countries: Canada, France, Germany
Source: ClinicalTrials.gov record NCT02428400. Inclusion in this directory is not an endorsement.