AzTrials
AzTrials

Chronic Hepatitis BPhase 1NCT02428400

Safety and Tolerability of TG1050: A Dose-finding Study

A Phase 1 study testing TG1050 in people with Chronic Hepatitis B, run by Transgene at 12 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis B
What is being tested?
TG1050
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
12 sitesin 3 countries
Study dates
Oct 2015to Nov 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18 through 65 years of age, inclusive
  • Patients must be undetectable for neutralizing antibodies to Adenovirus serotype 5 (Ad5) (PART A ONLY)
  • Negative serum β-HCG (for women of childbearing potential only; women of non-childbearing potential are defined as a woman who has been postmenopausal for ≥ 2 years or who had had a hysterectomy, bilateral oophorectomy, or medically documented ovarian failure)
  • Female patients of childbearing potential must be willing to use double effective methods of contraception (e.g. two of the following: hormonal contraception, condom or occlusive cap, intrauterine device (IUD) or intrauterine system (IUS), male sterilisation, or true abstinence) through 3 months after the last IMP administration; male patients must agree to use a double effective method of contraception (e.g. two of the following: hormonal contraception, condom or occlusive cap, IUD or IUS, male sterilisation, or true abstinence) during heterosexual intercourse with a partner capable of becoming pregnant throughout 3 months after the last IMP administration
  • Currently on treatment for HBV monoinfection (any HBV genotypes) for at least 2 years with either the nucleos(t)ide analogue TDF or ENT
  • A history of HBV DNA < 20 IU/mL for at least 6 months before entry and HBV DNA < 20 IU/mL at screening.
Show all 13Show fewer
  • HBsAg positive
  • HBeAg positive or HBeAg negative patients with HBV infection
  • Compensated liver disease; defined as direct or conjugated bilirubin ≤ 1.2 × ULN, PT/INR ≤ 1.2 × ULN, platelets ≥ 150,000/mm3, serum albumin ≥ 3.5 g/L, and no prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage)
  • ALT ≤ 1.5 x ULN. Due to its biological variability, a re-test of the ALT parameter is allowed if the ALT value at screening does not exceed 10% of the 1.5 x ULN value and all other eligibility criteria are met. In this case, the ALT re-test can be performed no more than one month after the initial ALT screening assay and has to be confirmed within 2 weeks. Values of the two ALT assays re-tests have to be below 1.5 x ULN to include the patient. In case of re-test of the ALT parameter, all hematology and biochemistry parameters will be reassessed in parallel of the second ALT re-test to ensure that they are still matching TG1050.02 eligibility criteria.• Hemoglobin ≥ 10 g/L
  • Creatinine clearance > 50mL/min
  • Neutrophils ≥ 1,500/mm3
  • Signed, written Independent Ethics Committee (IEC)-approved informed consent

Who cannot join

  • Patients with any evidence of hepatocellular carcinoma or any other liver cancer
  • Patients with α-fetoprotein > 50 ng/mL
  • Patients co-infected with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis Delta virus (HDV)
  • Patients with either a) medical history or evidence of cirrhosis who had any biopsy showing cirrhosis or any approved non-invasive test indicative of cirrhosis as documented in the medical source documents; OR b) either of the following at screening: transient elastography score ≥ 10.5 kPa OR a Fibrotest® Fibrosure® score of ≥ 0.48 and an aspartate aminotransferase platelet ratio Index (APRI) of ≥1. Note: If a biopsy or non-invasive test has never been performed or if a biopsy or non-invasive test has been performed but showed no cirrhosis, then b) must be followed at screening
  • Patients with a history of uncontrolled thyroid disease or abnormal thyroid stimulating hormone (TSH) levels at screening (defined as < 0.8 × lower limit of normal [LLN] or > 1.2 × ULN; patients are eligible with abnormal TSH levels if the free triiodothyronine (FT3) and free thyroxine (FT4) are within normal limits)
  • Significant concomitant medical disorder including active systemic infection or proven or suspected immunosuppressive disorder
Show all 15Show fewer
  • History of immunodeficiency or autoimmune disease (including autoimmune hepatitis, or preexisting autoimmune or antibody-mediated disease)
  • Current or history of clinically significant oncologic, pulmonary, hepatic, gastrointestinal, renal, cardiovascular, metabolic, endocrine, neurologic, hematologic illness, major organ transplantation, or any other major medical disorder that, in the judgment of the investigator, would interfere with patient treatment, or preclude patient participation in this study; should be discussed case by case with the Sponsor
  • Pregnant or breast-feeding women
  • Prior treatment with an experimental gene therapy product or a gene therapy product
  • Prior participation in another research protocol involving an investigation medicinal product (IMP) within 4 months prior to TG1050/placebo injection
  • History of substance abuse, including alcohol abuse that in the judgment of the investigator would deem the patient as not be suitable for participation in the study
  • Patients unable or unwilling to comply with the protocol requirements
  • All key inclusion and exclusion criteria remain the same for patients in Part A, MD Cohort and in Part B of the study except for the following:
  • Patients with detectable or undetectable anti-Ad5 neutralizing antibodies are eligible (i.e. regardless of their pre-immunity to Ad5 nAb).

Trial locations and contacts

12 sites in 3 countries.

12 sites in 3 countries

France5 sites

  • Study site

    Grenoble

  • Study site

    Lyon

  • Study site

    Nancy

  • Study site

    Paris

  • Study site

    Strasbourg

Other trials in France

Germany4 sites

  • Study site

    Freiburg im Breisgau

  • Study site

    Hamburg

  • Study site

    Hanover

  • Study site

    Mainz

Other trials in Germany

Canada3 sites

  • Study site

    Calgary

  • Study site

    Edmonton, Alberta

  • Study site

    Montreal

Other trials in Canada

About this study

Official title: 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

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

Being tested
TG1050, Placebo
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TG1050Biological

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

  • PlaceboBiological

    Placebo: adenovirus reference material (ARM) buffer

Study groups in NCT02428400
Study groupRoleWhat they receive
TG1050ExperimentalTG1050 SD cohort, administered SC as a single injection: 9.0 Log [10^9] 10.0 Log [10^10], 11.0 Log [10^11] virus particles TG1050 MD cohort, administered SC as 3 once weekly injections:9.0 Log [10^9] 10.0 Log [10^10], 11.0 Log [10^11] virus particles TG1050 Part B cohort, dose(s) and schedule to be determined
Receives: Biological: TG1050
PlaceboPlacebo comparatorPlacebo SD cohort, administered SC as a single injection: 9.0 Log [10^9] 10.0 Log [10^10], 11.0 Log [10^11] virus particles Placebo MD cohort, administered SC as 3 once weekly injections: 9.0 Log [10^9] 10.0 Log [10^10], 11.0 Log [10^11] virus particles Placebo Part B cohort, dose(s) and schedule to be determined
Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability of TG1050 administered as single or multiple doses: Overall number of AEs, including SAEs, Grade 3 or 4 AEs, Grade 3 or 4 laboratory abnormalities, and any AE leading to a permanent discontinuation of IMP for any reason.

    Measured: Week 54

  2. Dosage of TG1050/placebo administration for investigation in Part B of the study will be determined.

    Measured: Week 54

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionNov 2018
  4. Study completionNov 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02428400
Sponsor's protocol ID
TG1050.02
Status last verified
Nov 2018
First submitted
18 Mar 2015
Last updated
27 Nov 2018
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TG1050 in people with Chronic Hepatitis B, run by Transgene at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France, Germany, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of TG1050 administered as single or multiple doses: Overall number of AEs, including SAEs, Grade 3 or 4 AEs, Grade 3 or 4 laboratory abnormalities, and any AE leading to a permanent discontinuation of IMP for any reason. (time frame: Week 54). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02428400.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in