Hepatitis CPhase 1/2Eclipse 2NCT01025297
Dose Escalation Study of Interleukin-7 (IL-7) and Bitherapy in HCV Genotype 1 or 4 Patients Resistant to Bitherapy Alone
A Phase 1/2 study testing Interleukin-7 in people with Hepatitis C, run by Cytheris SA at 8 sites in 3 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 standard bi-therapy in patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Interleukin-7
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 8 sitesin 3 countries
- Study dates
- Jul 2008to 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
- Genotype 1 or 4 infected patients
- Age > 18 years
- Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin defined as:
- Absence of early viral response (EVR) with detectable HCV and with a decrease HCV RNA load < 2 logs, measured by a quantitative PCR tests after 12 weeks of treatment, as compared to baseline levels measured by a similar technique; or
- Absence of end of treatment response defined by detectable HCV RNA at the end of treatment (24 weeks or 48 weeks)
- Metavir ≤ F3 assessed by biopsy in the last 12 months or by fibroscan if Fibroscan® result < 10 kPa in the last 6 months (biopsy can be avoided)
Who cannot join
- Active infection by HBV (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load).
- Infection by HIV-1 and /or HIV-2
- Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization
- Other liver disease (notably from alcoholic, metabolic or immunological origin)
- Body mass index (BMI) > 30kg/m2
- Relapse after previous response to pegylated IFN alpha and ribavirin therapy
Show all 13Show fewer
- Any history of malignancy apart from curatively treated basal cell carcinoma or in situ cervical carcinoma
- History of clinical autoimmune disease or active auto-immune disease
- History of severe asthma, presently on chronic medications
- Significant cardiac or pulmonary disease
- Prior solid organ or hematopoietic cell transplantation
- Dialyzed patient
- Inability to give informed consent
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
France4 sites
Hopital Jean Verdier
Bondy
Beaujon Hospital
Clichy
Hopital Kremlin Bicêtre
Le Kremlin-Bicêtre
Hopital Civil
Strasbourg
Italy3 sites
Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi
Bologna
Fatebenefratelli e Oftalmico
Milan
San Raffaele Scientific Institute
Milan
About this study
Official title: A Phase I/IIa Dose Escalation Study of Repeated Administration of "CYT107" (Glyco-r-hIL-7) Add-On Treatment in Genotype 1 or 4 Hcv Infected Patients Resistant to Pegylated Interferon-Alpha and Ribavirin
This study is designed to evaluate the safety of biological active dose of a new experimental drug, IL-7, in combination with standard bi-therapy in patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.
Read the detailed description
This is a Phase I/IIa inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in adult patients infected by virus genotype 1 or 4 of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (bitherapy).
The dose escalation is aimed at establishing the safety of a biologically active doses of CYT107 added to the combination therapy of pegylated interferon-alpha and ribavirin. At each dose level, study patients will receive one subcutaneous administration of CYT107 per week for a total of 4.
Groups of 6 patients will be entered at each dose level of CYT107. Three dose levels are planned.
Eligible patients initially receive bi-therapy for 6-10 weeks. Thereafter, CYT107 is added for a cycle of four weekly injections at a defined dose level while standard bi-therapy continues for 9 weeks after CYT107 treatment discontinuation. The patients are then followed on a regular basis until reaching 48 weeks after the CYT107 treatment. The duration of study is approximatively 60 weeks with 20-25 weeks of bi-therapy.
Participants will have 1 overnight hospitalization and 15 clinic visit on a period of 60 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
- Hepatitis C
- Being tested
- Interleukin-7
- Keywords
- interleukin-7, immune-based therapies, hepatitis C, chronic hepatitis, resistance to Peg-interferon and ribavirin bi-therapy, immune specific responses to HCV, phase 1/2a, viral disease, liver disease
- Medical subject headings
- Hepatitis C, 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.
Interleukin-7Drug
3 dose levels: 3, 10 \& 20 µg/kg. 4 administrations, 1 per week
| Study group | Role | What they receive |
|---|---|---|
| CYT107 | Experimental | Not described Receives: Drug: Interleukin-7 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate at W 12 the safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin
Measured: 12 weeks after the start of IL-7
Secondary outcomes (4)
To characterize pharmacokinetics and pharmacodynamics of CYT107
Measured: 12 weeks after the start of IL-7
To evaluate in the context of a dose escalation strategy the potential anti-viral effect of CYT107
Measured: 12 weeks after the start of IL-7
To evaluate the immune specific response to HCV
Measured: 12 weeks after the start of IL-7
To document the long-term safety and viral load variations
Measured: 48 weeks after the start of IL-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startJul 2008
- Primary completionDec 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 Hepatitis CStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cytheris SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tilman Gerlach, Study chair, Hospital of San Gallen-Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025297
- Sponsor's protocol ID
- CLI-107-07
- Acronym
- Eclipse 2
- Status last verified
- Oct 2012
- First submitted
- 2 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 I/IIa Dose Escalation Study of Repeated Administration of "CYT107" (Glyco-r-hIL-7) Add-On Treatment in Genotype 1 or 4 Hcv Infected Patients Resistant to Pegylated Interferon-Alpha and Ribavirin
- ClinicalTrials.gov ID
- NCT01025297
- Acronym / sponsor ID
- Eclipse 2 / CLI-107-07
- Conditions
- Hepatitis C
- Keywords
- interleukin-7, immune-based therapies, hepatitis C, chronic hepatitis, resistance to Peg-interferon and ribavirin bi-therapy, immune specific responses to HCV, phase 1/2a, viral disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Cytheris SAIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 3 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 standard bi-therapy in patients with Hepatitis C chronic infection identified as non responders to the standard bi-therapy alone.
Detailed description
This is a Phase I/IIa inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in adult patients infected by virus genotype 1 or 4 of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (bitherapy).
The dose escalation is aimed at establishing the safety of a biologically active doses of CYT107 added to the combination therapy of pegylated interferon-alpha and ribavirin. At each dose level, study patients will receive one subcutaneous administration of CYT107 per week for a total of 4.
Groups of 6 patients will be entered at each dose level of CYT107. Three dose levels are planned.
Eligible patients initially receive bi-therapy for 6-10 weeks. Thereafter, CYT107 is added for a cycle of four weekly injections at a defined dose level while standard bi-therapy continues for 9 weeks after CYT107 treatment discontinuation. The patients are then followed on a regular basis until reaching 48 weeks after the CYT107 treatment. The duration of study is approximatively 60 weeks with 20-25 weeks of bi-therapy.
Participants will have 1 overnight hospitalization and 15 clinic visit on a period of 60 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CYT107 | Experimental | Drug: Interleukin-7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Genotype 1 or 4 infected patients
- Age > 18 years
- Absence of viral response to previous treatments with pegylated interferon-alpha plus ribavirin defined as:
- Metavir ≤ F3 assessed by biopsy in the last 12 months or by fibroscan if Fibroscan® result < 10 kPa in the last 6 months (biopsy can be avoided)
Key exclusion criteria (13 listed)
- Active infection by HBV (positive HBs Ag or positive anti HBc antibodies with a detectable HBV DNA viral load).
- Infection by HIV-1 and /or HIV-2
- Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization
- Other liver disease (notably from alcoholic, metabolic or immunological origin)
- Body mass index (BMI) > 30kg/m2
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 |
|---|---|---|
| Interleukin-73 dose levels: 3, 10 \& 20 µg/kg. 4 administrations, 1 per week | Drug | CYT107 |
Primary outcome
To evaluate at W 12 the safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin
Time frame: 12 weeks after the start of IL-7
4 secondary outcomes
To characterize pharmacokinetics and pharmacodynamics of CYT107
Time frame: 12 weeks after the start of IL-7
To evaluate in the context of a dose escalation strategy the potential anti-viral effect of CYT107
Time frame: 12 weeks after the start of IL-7
To evaluate the immune specific response to HCV
Time frame: 12 weeks after the start of IL-7
To document the long-term safety and viral load variations
Time frame: 48 weeks after the start of IL-7
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.
Tilman Gerlach study chair
Hospital of San Gallen-Switzerland
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Interleukin-7 in people with Hepatitis C, run by Cytheris SA at 8 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 6 inclusion and 13 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, Switzerland. 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 evaluate at W 12 the safety of biologically active doses of CYT107 added to a combination therapy by pegylated interferon-alpha and ribavirin (time frame: 12 weeks after the start of IL-7). 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.