Hepatitis CPhase 2COPE-HCVNCT00919633
Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C
A Phase 2 study testing interferon alfa-2b, peginterferon alfa-2b and ribavirin, USP in people with Hepatitis C, run by Medtronic Corporate Technologies and New Ventures at 1 site in United States.
Trial summary
The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis C infection as compared to patients who receive standard treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- interferon alfa-2b, peginterferon alfa-2b and ribavirin, USP
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Jul 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Signed patient consent form
- Genotype 1 chronic HCV with detectable HCV RNA
- No previous treatment for HCV infection
- Hepatitis B and human immunodeficiency virus negative at screening visit
- Able and willing to follow contraception requirements
- Screening laboratory values, test, and physical exam within acceptable ranges
- Weight between 40 kg and 125 kg
- Proficiency in the use of the external pump infusion system
Who cannot join
- Current or planned enrollment in another investigational device or drug study
- Anticipated inability to complete all clinic visits and comply with study procedures
- History of, or any current medical condition, which could impact the safety of the subject during the study
- Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV
- Alcoholism or substance abuse with <6 documented months of sobriety
- Known allergy or sensitivity to interferons or ribavirin
- Any other condition that, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Clinical Research Institute
Durham, North Carolina, 27705
About this study
Official title: COPE-HCV: Continuous Interferon Delivery Via the Medtronic Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV
The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis C infection as compared to patients who receive standard treatment.
Read the detailed description
The study will include patients who are diagnosed with chronic hepatitis C genotype 1 infection and who have received no previous interferon or other anti-HCV treatment.
- Conditions
- Hepatitis C
- Being tested
- interferon alfa-2b, peginterferon alfa-2b, ribavirin, USP, external drug infusion pump
- Keywords
- hepatitis C, HCV, genotype, sustained virological response, rapid virological response, interferon
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interferon alfa-2bDrug
Also called INTRON® A
subcutaneous continuous infusion at one of three doses for 48 weeks
peginterferon alfa-2bDrug
Also called PEGINTRON™
1.5 μg/kg subcutaneous weekly for 48 weeks
ribavirin, USPDrug
Also called Rebetol®
All patients will receive oral ribavirin
external drug infusion pumpDevice
Also called Medtronic MiniMed™ Paradigm® Insulin Pump Infusion System
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
| Study group | Role | What they receive |
|---|---|---|
| Group 1: interferon alfa-2b (dose 1) | Experimental | continuous subcutaneous infusion for 48 weeks Receives: Drug: interferon alfa-2b; Drug: ribavirin, USP; Device: external drug infusion pump |
| Group 2: interferon alfa-2b (dose 2) | Experimental | continuous subcutaneous infusion for 48 weeks Receives: Drug: interferon alfa-2b; Drug: ribavirin, USP; Device: external drug infusion pump |
| Group 3: interferon alfa-2b (dose 3) | Experimental | continuous subcutaneous infusion for 48 weeks Receives: Drug: interferon alfa-2b; Drug: ribavirin, USP; Device: external drug infusion pump |
| Group 4: peginterferon alfa-2b (1.5 μg/kg) | Active comparator | subcutaneous weekly for 48 weeks Receives: Drug: peginterferon alfa-2b; Drug: ribavirin, USP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Load: Incidence of Sustained Virologic Response (SVR)
Measured: 24 weeks after treatment is complete
Secondary outcomes (2)
Rapid Virologic Response (RVR)
Measured: Study Week 4
Early Virologic Response (EVR)
Measured: Study week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Corporate Technologies and New Ventures
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Muir, M.D., Principal investigator, Duke Clinical Research InstituteSarah Mische, PhD, Study director, Medtronic Ventures and New Therapies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919633
- Sponsor's protocol ID
- 4316001
- Acronym
- COPE-HCV
- Status last verified
- Sep 2019
- First submitted
- 10 Jun 2009
- Last updated
- 9 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COPE-HCV: Continuous Interferon Delivery Via the Medtronic Paradigm Pump Infusion System Clinical Evaluation for Chronic HCV
- ClinicalTrials.gov ID
- NCT00919633
- Acronym / sponsor ID
- COPE-HCV / 4316001
- Conditions
- Hepatitis C
- Keywords
- hepatitis C, HCV, genotype, sustained virological response, rapid virological response, interferon
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Medtronic Corporate Technologies and New VenturesIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Posted 30 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate if continuous subcutaneous delivery of interferon alfa-2b using an external drug pump in combination with the use of oral ribavirin provides a safe and effective treatment for patients with chronic hepatitis C infection as compared to patients who receive standard treatment.
Detailed description
The study will include patients who are diagnosed with chronic hepatitis C genotype 1 infection and who have received no previous interferon or other anti-HCV treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: interferon alfa-2b (dose 1) | Experimental | Drug: interferon alfa-2b, Drug: ribavirin, USP, Device: external drug infusion pumpcontinuous subcutaneous infusion for 48 weeks |
| Group 2: interferon alfa-2b (dose 2) | Experimental | Drug: interferon alfa-2b, Drug: ribavirin, USP, Device: external drug infusion pumpcontinuous subcutaneous infusion for 48 weeks |
| Group 3: interferon alfa-2b (dose 3) | Experimental | Drug: interferon alfa-2b, Drug: ribavirin, USP, Device: external drug infusion pumpcontinuous subcutaneous infusion for 48 weeks |
| Group 4: peginterferon alfa-2b (1.5 μg/kg) | Active comparator | Drug: peginterferon alfa-2b, Drug: ribavirin, USPsubcutaneous weekly for 48 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Signed patient consent form
- Genotype 1 chronic HCV with detectable HCV RNA
- No previous treatment for HCV infection
- Hepatitis B and human immunodeficiency virus negative at screening visit
- Able and willing to follow contraception requirements
Key exclusion criteria (7 listed)
- Current or planned enrollment in another investigational device or drug study
- Anticipated inability to complete all clinic visits and comply with study procedures
- History of, or any current medical condition, which could impact the safety of the subject during the study
- Autoimmune hepatitis, suspected hepatocellular carcinoma, decompensated liver disease, or other known liver disease other than HCV
- Alcoholism or substance abuse with <6 documented months of sobriety
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 |
|---|---|---|
| interferon alfa-2bAlso: INTRON® Asubcutaneous continuous infusion at one of three doses for 48 weeks | Drug | Group 1: interferon alfa-2b (dose 1), Group 2: interferon alfa-2b (dose 2), Group 3: interferon alfa-2b (dose 3) |
| peginterferon alfa-2bAlso: PEGINTRON™1.5 μg/kg subcutaneous weekly for 48 weeks | Drug | Group 4: peginterferon alfa-2b (1.5 μg/kg) |
| ribavirin, USPAlso: Rebetol®All patients will receive oral ribavirin | Drug | Group 1: interferon alfa-2b (dose 1), Group 2: interferon alfa-2b (dose 2), Group 3: interferon alfa-2b (dose 3), Group 4: peginterferon alfa-2b (1.5 μg/kg) |
| external drug infusion pumpAlso: Medtronic MiniMed™ Paradigm® Insulin Pump Infusion Systempump delivery system for continuous subcutaneous infusion of interferon alfa-2b | Device | Group 1: interferon alfa-2b (dose 1), Group 2: interferon alfa-2b (dose 2), Group 3: interferon alfa-2b (dose 3) |
Primary outcome
Viral Load: Incidence of Sustained Virologic Response (SVR)
Time frame: 24 weeks after treatment is complete
2 secondary outcomes
Rapid Virologic Response (RVR)
Time frame: Study Week 4
Early Virologic Response (EVR)
Time frame: Study week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Common terminology criteria for adverse events, version 3.0Link provided by the sponsor.
- International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted to biomedical journals: writing and editing for biomedical publication. Publication ethics: sponsorship, authorship and accountability.Link provided by the sponsor.
Related trials for Hepatitis C
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
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.
Andrew Muir, M.D. principal investigator
Duke Clinical Research Institute
Sarah Mische, PhD study director
Medtronic Ventures and New Therapies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing interferon alfa-2b, peginterferon alfa-2b and ribavirin, USP in people with Hepatitis C, run by Medtronic Corporate Technologies and New Ventures at 1 site in United States.
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 8 inclusion and 7 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 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 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?
Yes. Results are posted in the registry (first posted 30 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Viral Load: Incidence of Sustained Virologic Response (SVR) (time frame: 24 weeks after treatment is complete). 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 9 Oct 2019.