Chronic Hepatitis BPhase 1/2CONVERTNCT01027065
Dose Escalation of Interleukin-1 (IL-7) Added on Antiviral Treatment and Vaccination in HBeAg-negative Chronic Hepatitis B Virus (HBV) Infected Patients
A Phase 1/2 study testing CYT107+GenHevac+entecavir or tenofovir and CYT107+ entecavir or tenofovir in people with Chronic Hepatitis B, run by Cytheris SA at 8 sites in 2 countries.
Trial summary
This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with anti viral therapy and vaccine in patients with Hepatitis B chronic infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B
- What is being tested?
- CYT107+GenHevac+entecavir or tenofovir and CYT107+ entecavir or tenofovir
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Dec 2009to Mar 2013
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic HBV-infected patients
- HBeAg-negative patients
- Age > 18 years
- Patients with active chronic hepatitis at the start of the antiviral treatment
- Patient with a HBV DNA undetectable (<70 copies/ml) stable for at least 3 months under entecavir or tenofovir treatment.
- Ongoing treatment by entecavir or tenofovir at screening Note: previous treatment with pegylated IFN monotherapy, before the start of entecavir or tenofovir, is acceptable
Who cannot join
- Infection by HCV
- Infection by HIV-1 and /or HIV-2
- Apart from HBV infection, presence of active infection requiring a specific treatment or a hospitalization
- Previous treatment by lamivudine and/or nucleosides analogues
- Inactive carrier
- Cirrhosis
Show all 10Show fewer
- Other liver disease (notably from alcoholic, metabolic or immunological origin)
- History of clinical autoimmune disease or active auto-immune disease
- Type I diabetes mellitus
- Severe asthma, presently on chronic medications
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
France7 sites
Hopital Henri Mendor-Service d'HepatoGastroEnterologie
Créteil
Hopital Michallon
Grenoble
Hopital de l'Hotel Dieu
Lyon
Hopital Saint Joseph
Marseille
CHU l'Archet
Nice
Hopital Tenon
Paris
Hopital Civil
Strasbourg
Italy1 site
Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi
Bologna
About this study
Official title: A Phase Randomized Open Labelled Controlled Dose Escalation Study of Repeated Administration of "CYT107" (Glyco-r-hIL-7) Added on Antiviral Treatment and Vaccination in HBeAg-negative Chronic Hepatitis B-infected Patients
This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with anti viral therapy and vaccine in patients with Hepatitis B chronic infection.
Read the detailed description
This is a Phase I/IIa inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in HBeAg-negative chronic hepatitis B infected adult patients. The dose escalation is aimed at establishing the safety of a biologically active doses of CYT107 added to the current antiviral therapy with entecavir or tenofovir and vaccination or not. At each dose level, study patients will receive one subcutaneous administration of CYT107 per week for a total of 4.
Groups of 8 patients will be entered at each dose level of CYT107. Three dose levels are planned.
At each dose level, patients are randomized between 2 arms of treatment: tritherapy (CYT107, vaccine and antiviral treatment) or bitherapy (CYT107 and vaccine). Each treatment group is composed of 4 patients, 3 receiving experimental treatments, 1 just the current antiviral treatment (control patient).
According to the treatment arm, eligible patients initially receive a vaccine if in treatment group of tritherapy, thereafter, CYT107 is added for a cycle of four weekly injections (if not a control patient) at a defined dose level. If in treatment group of tritherapy, patients will receive 2 additional doses of vaccine.
The treatment phase for the tritherapy group is from first vaccine D0 to last vaccine W12 and includes CYT107 administration from W4 to W7.
The treatment phase for the bitehrapy group is from W4 to W7 corresponding to CYT104 injections.
The patients are then followed on a regular basis until reaching 52 weeks after the D0.
Participants will have 1 overnight hospitalization and 12 clinic visit on a period of 55 weeks.
During the visits the following may be done:
- medical history, physical examination, blood tests
- electrocardiograms (ECG)
- chest X-Ray
- liver/spleen imaging
- urine tests
- Conditions
- Chronic Hepatitis B
- Being tested
- CYT107+GenHevac+entecavir or tenofovir, CYT107+ entecavir or tenofovir
- Keywords
- interleukin-7, immune-based therapies, hepatitis B, HBe negative, HBV vaccination, entecavir, tenofovir, chronic hepatitis, immune specific responses to HBV, phase 1/2a, viral disease, liver disease
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis B, Hepatitis, Chronic, Virus Diseases, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT107+GenHevac+entecavir or tenofovirDrug
4 patients per arm for each dose level. 3 patients receiving experimental treatment (CYT107 and vaccine) in addition to current antiviral treatment and 1 control patient only the current antiviral treatment
CYT107+ entecavir or tenofovirDrug
4 patients per arm for each dose level. 3 patients receiving experimental treatment (CYT107) in addition to current antiviral treatment and 1 control patient only the current antiviral treatment
| Study group | Role | What they receive |
|---|---|---|
| Tritherapy: CYT107+ vaccine+ antiviral | Experimental | Not described Receives: Drug: CYT107+GenHevac+entecavir or tenofovir |
| Bitherapy: CYT107 + antiviral | Experimental | Not described Receives: Drug: CYT107+ entecavir or tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the short and long-term safety and biological activity of CYT107 in patients with a HBeAg-negative chronic hepatitis B who have, at screening a HBV DNA undetectable stable for at least 3 months with antiviral treatment.
Measured: Week 12
Secondary outcomes (3)
To characterize the pharmacokinetics and pharmacodynamics of CYT107 in humans chronically infected with HBV.
Measured: Week 12
To assess the effects of the tri-therapy (CYT107 + HBV vaccine + antiviral treatment) versus bi-therapy (CYT107 + antiviral treatment) versus control (antiviral treatment) on the markers of the HBV infection (antiviral activity)at W16 weeks and W52
Measured: Week 12 and Week 52
To quantify the effects of the tri-therapy (CYT107 + HBV vaccine + antiviral treatment) versus bi-therapy (CYT107 + antiviral treatment) versus control (antiviral treatment) on the immune system at W16 weeks
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionNov 2012 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytheris SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christophe Hezode, Study chair, Hopital Henri Mondor-Créteil-FrancePietro Andreone, Principal investigator, S. Orsola Malpighi- Bologna-Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01027065
- Sponsor's protocol ID
- CLI-107-10
- Other IDs
- 2009-010709-35, 2009
- Acronym
- CONVERT
- Status last verified
- Oct 2012
- First submitted
- 4 Dec 2009
- Last updated
- 18 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Randomized Open Labelled Controlled Dose Escalation Study of Repeated Administration of "CYT107" (Glyco-r-hIL-7) Added on Antiviral Treatment and Vaccination in HBeAg-negative Chronic Hepatitis B-infected Patients
- ClinicalTrials.gov ID
- NCT01027065
- Acronym / sponsor ID
- CONVERT / CLI-107-10
- Conditions
- Chronic Hepatitis B
- Keywords
- interleukin-7, immune-based therapies, hepatitis B, HBe negative, HBV vaccination, entecavir, tenofovir, chronic hepatitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cytheris SAIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Nov 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 7 Dec 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with anti viral therapy and vaccine in patients with Hepatitis B chronic infection.
Detailed description
This is a Phase I/IIa inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in HBeAg-negative chronic hepatitis B infected adult patients. The dose escalation is aimed at establishing the safety of a biologically active doses of CYT107 added to the current antiviral therapy with entecavir or tenofovir and vaccination or not. At each dose level, study patients will receive one subcutaneous administration of CYT107 per week for a total of 4.
Groups of 8 patients will be entered at each dose level of CYT107. Three dose levels are planned.
At each dose level, patients are randomized between 2 arms of treatment: tritherapy (CYT107, vaccine and antiviral treatment) or bitherapy (CYT107 and vaccine). Each treatment group is composed of 4 patients, 3 receiving experimental treatments, 1 just the current antiviral treatment (control patient).
According to the treatment arm, eligible patients initially receive a vaccine if in treatment group of tritherapy, thereafter, CYT107 is added for a cycle of four weekly injections (if not a control patient) at a defined dose level. If in treatment group of tritherapy, patients will receive 2 additional doses of vaccine.
The treatment phase for the tritherapy group is from first vaccine D0 to last vaccine W12 and includes CYT107 administration from W4 to W7.
The treatment phase for the bitehrapy group is from W4 to W7 corresponding to CYT104 injections.
The patients are then followed on a regular basis until reaching 52 weeks after the D0.
Participants will have 1 overnight hospitalization and 12 clinic visit on a period of 55 weeks.
During the visits the following may be done:
- medical history, physical examination, blood tests
- electrocardiograms (ECG)
- chest X-Ray
- liver/spleen imaging
- urine tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tritherapy: CYT107+ vaccine+ antiviral | Experimental | Drug: CYT107+GenHevac+entecavir or tenofovir |
| Bitherapy: CYT107 + antiviral | Experimental | Drug: CYT107+ entecavir or tenofovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Chronic HBV-infected patients
- HBeAg-negative patients
- Age > 18 years
- Patients with active chronic hepatitis at the start of the antiviral treatment
- Patient with a HBV DNA undetectable (<70 copies/ml) stable for at least 3 months under entecavir or tenofovir treatment.
Key exclusion criteria (10 listed)
- Infection by HCV
- Infection by HIV-1 and /or HIV-2
- Apart from HBV infection, presence of active infection requiring a specific treatment or a hospitalization
- Previous treatment by lamivudine and/or nucleosides analogues
- Inactive carrier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYT107+GenHevac+entecavir or tenofovir4 patients per arm for each dose level. 3 patients receiving experimental treatment (CYT107 and vaccine) in addition to current antiviral treatment and 1 control patient only the current antiviral treatment | Drug | Tritherapy: CYT107+ vaccine+ antiviral |
| CYT107+ entecavir or tenofovir4 patients per arm for each dose level. 3 patients receiving experimental treatment (CYT107) in addition to current antiviral treatment and 1 control patient only the current antiviral treatment | Drug | Bitherapy: CYT107 + antiviral |
Primary outcome
To determine the short and long-term safety and biological activity of CYT107 in patients with a HBeAg-negative chronic hepatitis B who have, at screening a HBV DNA undetectable stable for at least 3 months with antiviral treatment.
Time frame: Week 12
3 secondary outcomes
To characterize the pharmacokinetics and pharmacodynamics of CYT107 in humans chronically infected with HBV.
Time frame: Week 12
To assess the effects of the tri-therapy (CYT107 + HBV vaccine + antiviral treatment) versus bi-therapy (CYT107 + antiviral treatment) versus control (antiviral treatment) on the markers of the HBV infection (antiviral activity)at W16 weeks and W52
Time frame: Week 12 and Week 52
To quantify the effects of the tri-therapy (CYT107 + HBV vaccine + antiviral treatment) versus bi-therapy (CYT107 + antiviral treatment) versus control (antiviral treatment) on the immune system at W16 weeks
Time frame: Week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe Hezode study chair
Hopital Henri Mondor-Créteil-France
Pietro Andreone principal investigator
S. Orsola Malpighi- Bologna-Italy
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CYT107+GenHevac+entecavir or tenofovir and CYT107+ entecavir or tenofovir in people with Chronic Hepatitis B, run by Cytheris SA at 8 sites in 2 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 6 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 18 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Italy. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
To determine the short and long-term safety and biological activity of CYT107 in patients with a HBeAg-negative chronic hepatitis B who have, at screening a HBV DNA undetectable stable for at least 3 months with antiviral treatment. (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2012.