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Hepatitis C, ChronicPhase 1NCT00529321

Immunotherapy With TG4040 in Treatment-naïve Patients Chronically Infected With Hepatitis C Virus

A Phase 1 study testing MVA-HCV (Immunotherapy) in people with Hepatitis C, Chronic, run by Transgene at 6 sites in France.

Completed

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

Official record
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Trial summary

The primary objective is to determine the safety of sub-cutaneous (SC) injections of TG4040 in non-cirrhotic, treatment-naïve patients chronically infected with HCV (genotype 1). Patients will be sequentially treated at an escalting dose of TG4040. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
MVA-HCV (Immunotherapy)
How many people
42 participants
Where
6 sitesFrance
Study dates
Dec 2006to Sep 2010
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

  • Informed consent obtained and signed;
  • Male or female patients;
  • With chronic hepatitis C (genotype 1) evidenced by HCV positive serology detectable for more than 6 months;
  • Patients with fibrosis status graded F0 or F1 according to the METAVIR grading system; patients with a F2 fibrosis stage could be enrolled on a case-by-case basis after being sure that they have a contraindication to be treated with an IFN-based standard HCV treatment; patients with F3 or F4 fibrosis stage will not be enrolled; this will be assessed either on the liver biopsy performed less than 18 months prior to baseline or on a FibroTest® and a FibroScan® performed within 2 months prior to first TG4040 injection; in case of discordant results, a liver biopsy will be performed prior to TG4040 treatment;;
  • Treatment-naïve patients: patients who have never received IFN-based treatment;
  • Patients must have compensated liver disease, with:
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  • No history of ascites, hepatic encephalopathy or bleeding from esophageal varices;
  • Laboratory tests values:
  • Serum alanine aminotransferase (ALT)less then 2 folds the Upper Limit of Normal (ULN);
  • Serum bilirubin and international normalized ratio (INR) values within normal range (except in patients with Gilbert syndrome where serum bilirubin may be as high as 3.0 mg/dL); and
  • Other laboratory parameters of grade 0 or 1 (CTC criteria);
  • For women of child-bearing potential, i.e. with no history of hysterectomy or tubal ligation, a negative pregnancy test at study entry and adequate protection against pregnancy during the conduct of the study and until 3 months after last TG4040 injection.
  • Additionnal cohorts:
  • Patients with high ALT level (2 folds ULN<ALT<5 folds ULN in the 2 months before inclusion) and fibrosis not higher than F2.

Who cannot join

  • Patients will be excluded from the study for any of the following reasons:
  • Co-infection with HBV (indicated by the presence of Hepatitis B Surface Antigen (HBsAg) in serum; patients with anti-hepatitis B core antibody response (anti-HBc) will not be excluded) or HIV (anti-HIV antibodies in serum); patients with HIV positive sexual partner (by history) will not be included;
  • Current HCV therapies;
  • Active IV drug or alcohol abuse;
  • Serious, concomitant disorder, including:
  • primary biliary cirrhosis or sclerosing cholangitis;
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  • auto-immune disease such as symptomatic cryoglobulinemia, polyarthritis, multiple sclerosis; a broad auto-immune testing will be performed at baseline;
  • proven or suspected immunosuppressive disorder;
  • active systemic infection; if the patient has acute febrile illness ( > 38°C) on the day of vaccination, it will be delayed by at least one week after complete recovery;
  • Malignancy within the last 5 years; patients with history of squamous cell skin cancer or basal cell skin cancer will be enrolled, unless the history of skin cancer is at the vaccination site;
  • Systemic corticosteroid therapy or other immunosuppressive/immunomodulating drugs (e.g. Cyclosporine) within 2 months prior to first study drug injection; corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are permissible;
  • Participation in another experimental protocol during the study period (last intake of investigational drug within 6 months prior to baseline);
  • Breast-feeding women;
  • Receipt of any inactivated vaccine 14 days prior to vaccination or for the duration of the study; receipt of any live attenuated vaccine within 30 days prior to vaccination or for the duration of the study;
  • Allergy to eggs;
  • Patient unable to comply with the protocol requirements;
  • Any condition that, in the opinion of the investigator, might interfere with study objectives.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

France6 sites

  • Hôpital Henri Mondor

    Créteil, 94010

  • Hopital A. Michallon

    La Tronche, 38700

  • Hopital de l'Hotel-Dieu

    Lyon, 69288

  • Hôpital de l'Hôtel Dieu

    Nantes, 44000

  • Hopital Civil

    Strasbourg, 67091

  • Hôpital de Brabois

    Vandœuvre-lès-Nancy, 54500

Other trials in France

About this study

Official title: Open-label, Dose-escalating, Phase I Study of TG4040 (MVA-HCV) in Treatment-naïve Patients Chronically Infected With Hepatitis C Virus (HCV Genotype 1)

The primary objective is to determine the safety of sub-cutaneous (SC) injections of TG4040 in non-cirrhotic, treatment-naïve patients chronically infected with HCV (genotype 1).

Patients will be sequentially treated at an escalting dose of TG4040. All patients will be followed up to at least 6 months after his/her first injection. In addition, all patients treated at the highest dose will receive a TG4040 boost injection 6 months after the first injection, and will be followed up during an additional 6-month period.

Read the detailed description

The first nine patients will be sequentially treated in three cohorts of three patients, i.e. they will receive 3 SC injections of TG4040 on Days 1, 8 and 15, at the dose of 10e6 pfu (first cohort), 10e7 pfu (second cohort), or 10e8 pfu (third cohort).

There will be a one-week safety interval between the first injection of the patients of a given cohort, and a two-week safety interval between the last injection of the last patient of a given cohort and the first injection of the first patient of the next one. There will be also a two-week safety observation period after the last injection of the last patient of the third cohort. If the dose of 10e8 pfu does not raise safety problems, then 6 patients will be further enrolled, without safety intervals between patients. They will receive 3 SC injections of TG4040 at the dose of 10e8 pfu, on Days 1, 8 and 15.

All patients will be followed up to at least 6 months after his/her first injection. In addition, all patients treated at the dose of 10e8 pfu will receive a TG4040 boost injection 6 months after the first injection, and will be followed up during an additional 6-month period.

Three additional cohorts of 9 patients will receive a boost injection either at 2, 4 or 6 months.

Being tested
MVA-HCV (Immunotherapy)
Medical subject headings
Hepatitis C, Chronic

What participants receive

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

  • MVA-HCV (Immunotherapy)Biological

    MVA-HCV

What is being measured

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

  1. Safety (adverse events, vital signs, physical examination, standard laboratory tests)

    Measured: regularly

Secondary outcomes (1)

  1. Virology (quantification of HCV-RNA), immunology (cellular-mediated and humoral immune responses)

    Measured: regularly

Timeline

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

  1. First posted14 Sep 2007 (estimated)
  2. Study startDec 2006
  3. Primary completionSep 2009
  4. Study completionSep 2010

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00529321
Sponsor's protocol ID
TG4040.01
Status last verified
Sep 2010
First submitted
7 Sep 2007
Last updated
3 Sep 2010
Results posted
No

Publications

  • Habersetzer F, Honnet G, Bain C, Maynard-Muet M, Leroy V, Zarski JP, Feray C, Baumert TF, Bronowicki JP, Doffoel M, Trepo C, Agathon D, Toh ML, Baudin M, Bonnefoy JY, Limacher JM, Inchauspe G. A poxvirus vaccine is safe, induces T-cell responses, and decreases viral load in patients with chronic hepatitis C. Gastroenterology. 2011 Sep;141(3):890-899.e1-4. doi: 10.1053/j.gastro.2011.06.009. Epub 2011 Jun 13.

    PubMed 21699798

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MVA-HCV (Immunotherapy) in people with Hepatitis C, Chronic, run by Transgene at 6 sites in France.

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 14 inclusion and 17 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 3 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. 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. 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 (adverse events, vital signs, physical examination, standard laboratory tests) (time frame: regularly). 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 NCT00529321, which also lists 1 linked publication.

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 3 Sep 2010.

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