Chronic Hepatitis CPhase 1NCT00519792
Phase 1b Study of Omega DUROS® in Patients With Chronic Hepatitis C Who Relapsed After Prior Treatment
A Phase 1 study testing Omega DUROS device in people with Chronic Hepatitis C, run by Intarcia Therapeutics at 8 sites in 2 countries.
Trial summary
Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days. This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Omega DUROS device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Aug 2007to Mar 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
- Chronic Hepatitis C with HCV genotype 1 infection
- Relapse following an end of treatment response after treatment with a pegylated interferon and ribavirin.
Who cannot join
- Presence or history of non-HCV chronic liver disease
- Treatment with any interferon subsequent to the relapse with pegylated interferon-alpha and ribavirin
- Decompensated liver disease
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States7 sites
The Liver Institute at Methodist Dallas
Dallas, Texas, 75203
Duke University Medical Center
Durham, North Carolina, 27710
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Weill Cornell Medical College
New York, New York, 10021
Alamo Medical Research
San Antonio, Texas, 28215
California Pacific Medical Center
San Francisco, California, 94115
St. Louis University
St Louis, Missouri, 63110
About this study
Official title: Phase Ib Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Omega DUROS® and Ribavirin in Subjects With Chronic Hepatitis C Previously Treated With Pegylated Interferon and Ribavirin
Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days.
This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with chronic Hepatitis C genotype 1.
- Conditions
- Chronic Hepatitis C
- Being tested
- Omega DUROS device
- Keywords
- Relapse, HCV, Hepatitis C, Interferon, Ribavirin
- Medical subject headings
- Hepatitis C, Chronic, Recurrence, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega DUROS deviceDrug
Omega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Omega DUROS: Dose 25 Receives: Drug: Omega DUROS device |
| 2 | Experimental | Omega DUROS: Dose 50 Receives: Drug: Omega DUROS device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intarcia Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519792
- Sponsor's protocol ID
- ITCA 638-CLP-08
- Status last verified
- Jun 2011
- First submitted
- 21 Aug 2007
- Last updated
- 8 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Omega DUROS® and Ribavirin in Subjects With Chronic Hepatitis C Previously Treated With Pegylated Interferon and Ribavirin
- ClinicalTrials.gov ID
- NCT00519792
- Acronym / sponsor ID
- ITCA 638-CLP-08
- Conditions
- Chronic Hepatitis C
- Keywords
- Relapse, HCV, Hepatitis C, Interferon, Ribavirin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Intarcia TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 23 Aug 2007 (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.
Omega DUROS® is an implantable drug delivery system designed to deliver omega interferon subcutaneously at a constant rate for 90 days.
This study is being performed to evaluate the safety and antiviral effects of omega interferon delivered by the Omega DUROS® device in combination with ribavirin in subjects with chronic Hepatitis C genotype 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Omega DUROS deviceOmega DUROS: Dose 25 |
| 2 | Experimental | Drug: Omega DUROS deviceOmega DUROS: Dose 50 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic Hepatitis C with HCV genotype 1 infection
- Relapse following an end of treatment response after treatment with a pegylated interferon and ribavirin.
Key exclusion criteria (3 listed)
- Presence or history of non-HCV chronic liver disease
- Treatment with any interferon subsequent to the relapse with pegylated interferon-alpha and ribavirin
- Decompensated liver disease
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 |
|---|---|---|
| Omega DUROS deviceOmega DUROS device 25mcg inserted SC for 48 weeks Omega DUROS device 50mcg inserted SC for 48 weeks | Drug | 1, 2 |
Primary outcome
Safety
Time frame: Week 52
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 8 Jun 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omega DUROS device in people with Chronic Hepatitis C, run by Intarcia Therapeutics 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 2 inclusion and 3 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 8 Jun 2011. 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 United States, Puerto Rico. 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 (time frame: Week 52). 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 8 Jun 2011.