Hepatitis CPhase 1/2ECLIPSE 1NCT01025596
Dose Escalation Study of IL-7 and Bi-therapy in HCV Patients Resistant After 12 Weeks of Bi-therapy (ECLIPSE 1)
A Phase 1/2 study testing Interleukin-7 in people with Hepatitis C, run by Cytheris SA at 7 sites in 3 countries.
Trial summary
This study will evaluate the safety of a new experimental drug, IL-7, in people with HCV infection resistant after 12 weeks of bi-therapy. 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
- 10 participants
- Where
- 7 sitesin 3 countries
- Study dates
- May 2007to Mar 2012
- 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
Main Inclusion Criteria:
- Genotype I infected patients
- Age > 18 years
- Absence of early viral response to a first treatment with PEG-interferon-alpha plus ribavirin given for at least 12 weeks. Absence of early viral response (EVR) will be defined as detectable HCV with a decrease HCV RNA load < 2 logs, measured by a quantitative PCR tests, as compared to baseline levels measured by a similar technique
- Ongoing treatment by PEG-interferon-alpha plus ribavirin at study entry
Main Exclusion Criteria:
- Infection by HBV
- Infection by HIV-1 and /or HIV-2
- Apart from HCV infection, presence of active infection requiring a specific treatment or a hospitalization
- Cirrhosis (Metavir F4) assessed by biopsy or FibroScan® or by liver biopsy within the last 6 months prior CYT107 treatment initiation. If assessed by Fibroscan® patients with a result > 10 KPa will be excluded
- Other liver disease (notably from alcoholic, metabolic or immunological origin)
- Body mass index (BMI) > 30kg/m2
- Inability to give informed consent
- Administration of growth factors (G-CSF, EPO) within the 12 weeks of the combination therapy
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
France4 sites
Hopital Jean Verdier
Bondy
Beaujon Hospital
Clichy
Hopital Kremlin Bicêtre
Le Kremlin-Bicêtre
Hopital Civil
Strasbourg
Italy2 sites
Azienda Ospedaliero-Universitaria, Policlinico Sant'Orsola Malpighi
Bologna
San Raffaele Scientific Institute
Milan
About this study
Official title: A PHASE I/IIa DOSE ESCALATION STUDY IN ASIA OF REPEATED ADMINISTRATION OF "CYT107" (Glyco-r-hIL-7) ADDED ON TREATMENT IN GENOTYPE 1 HCV INFECTED PATIENTS RESISTANT TO PEGYLATED INTERFERON-ALPHA AND RIBAVIRIN
This study will evaluate the safety of a new experimental drug, IL-7, in people with HCV infection resistant after 12 weeks of bi-therapy.
Read the detailed description
This is a Phase I inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in adult patients infected by Genotype 1 Virus of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (biotherapy)after 12 weeks of this standard bi-therapy.
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 a subcutaneous administration of CYT107 per week for a total of 4 administrations.
Groups of 3 to 6 patients will be entered at each dose level of CYT107. Four dose levels are planned.
Eligible patients will a cycle of four weekly injections at a defined dose level in addition to the bi-therapy. Standard bi-therapy will continue 4 weeks after CYT107 treatment discontinuation. The duration of study is approximately 11 weeks including screening period.
Participants have 1 hospitalization overnight and 8 clinic visits. The four administrations are sub-cutaneous and are given as a shot under the skin in the arm or abdomen or leg.
During the study visits the following may be done:
- Medical history, physical examination, blood tests every visit.
- Electrocardiogram (EKG)
- Chest x-ray study
- Liver/spleen imaging
- Blood sample collections at frequent intervals
- Urine tests several times during the study.
- 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, 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
4dose levels: 3, 10, 20 and 30µg/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.
Safety of biologically active doses of CYT107 added to a standard bi-therapy in patients with a chronic infection by a genotype 1 Hepatitis C Virus (HCV) not responding to this combination therapy 12 weeks after its initiation.
Measured: 8 weeks after start of CYT107
Secondary outcomes (3)
Pharmacokinetics and pharmacodynamics of CYT107 in this patients population.
Measured: As primary
potential anti-viral effect of CYT107
Measured: As primary
immune specific response to HCV
Measured: As primary
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 startMay 2007
- Primary completionFeb 2011
- Study completionMar 2012
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cytheris SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tilman Gerlach, Study chair, University of Zurich / Saint Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025596
- Sponsor's protocol ID
- CLI-107-05
- Other IDs
- EudraCT number 2006-006024-20
- Acronym
- ECLIPSE 1
- Status last verified
- Oct 2012
- First submitted
- 1 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 IN ASIA OF REPEATED ADMINISTRATION OF "CYT107" (Glyco-r-hIL-7) ADDED ON TREATMENT IN GENOTYPE 1 HCV INFECTED PATIENTS RESISTANT TO PEGYLATED INTERFERON-ALPHA AND RIBAVIRIN
- ClinicalTrials.gov ID
- NCT01025596
- Acronym / sponsor ID
- ECLIPSE 1 / CLI-107-05
- 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, viral disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cytheris SAIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2012 (actual)
- 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 will evaluate the safety of a new experimental drug, IL-7, in people with HCV infection resistant after 12 weeks of bi-therapy.
Detailed description
This is a Phase I inter-patient dose-escalation study assessing weekly doses of Interleukin-7 (CYT107) in adult patients infected by Genotype 1 Virus of Hepatitis C and resistant to standard treatment with Peg-Interferon and Ribavirin (biotherapy)after 12 weeks of this standard bi-therapy.
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 a subcutaneous administration of CYT107 per week for a total of 4 administrations.
Groups of 3 to 6 patients will be entered at each dose level of CYT107. Four dose levels are planned.
Eligible patients will a cycle of four weekly injections at a defined dose level in addition to the bi-therapy. Standard bi-therapy will continue 4 weeks after CYT107 treatment discontinuation. The duration of study is approximately 11 weeks including screening period.
Participants have 1 hospitalization overnight and 8 clinic visits. The four administrations are sub-cutaneous and are given as a shot under the skin in the arm or abdomen or leg.
During the study visits the following may be done:
- Medical history, physical examination, blood tests every visit.
- Electrocardiogram (EKG)
- Chest x-ray study
- Liver/spleen imaging
- Blood sample collections at frequent intervals
- Urine tests several times during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- 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
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-74dose levels: 3, 10, 20 and 30µg/kg. 4 administrations, 1 per week | Drug | CYT107 |
Primary outcome
Safety of biologically active doses of CYT107 added to a standard bi-therapy in patients with a chronic infection by a genotype 1 Hepatitis C Virus (HCV) not responding to this combination therapy 12 weeks after its initiation.
Time frame: 8 weeks after start of CYT107
3 secondary outcomes
Pharmacokinetics and pharmacodynamics of CYT107 in this patients population.
Time frame: As primary
potential anti-viral effect of CYT107
Time frame: As primary
immune specific response to HCV
Time frame: As primary
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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
University of Zurich / Saint Gallen
7 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 7 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?
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 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 7 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?
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 of biologically active doses of CYT107 added to a standard bi-therapy in patients with a chronic infection by a genotype 1 Hepatitis C Virus (HCV) not responding to this combination therapy 12 weeks after its initiation. (time frame: 8 weeks after start of CYT107). 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.