ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C (COPE-HCV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00919633
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : April 30, 2014
Last Update Posted : April 30, 2014
Sponsor:
Information provided by (Responsible Party):
Medtronic Corporate Technologies and New Ventures

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: interferon alfa-2b
Drug: peginterferon alfa-2b
Drug: ribavirin, USP
Device: external drug infusion pump

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Enrollment 09-Jun-2009, final subject complete 19-Jun-2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
210 screened, 116 randomized, 106 received at least 1 dose of study drug.

Reporting Groups
  Description
Group 4: Peginterferon Alfa-2b (1.5 μg/kg)

subcutaneous weekly for 48 weeks

peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

Group 1: Interferon Alfa-2b (Dose 1)

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

Group 2: Interferon Alfa-2b (Dose 2)

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

Group 3: Interferon Alfa-2b (Dose 3)

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin


Participant Flow:   Overall Study
    Group 4: Peginterferon Alfa-2b (1.5 μg/kg)   Group 1: Interferon Alfa-2b (Dose 1)   Group 2: Interferon Alfa-2b (Dose 2)   Group 3: Interferon Alfa-2b (Dose 3)
STARTED   28   25   27   26 
COMPLETED   6   10   4   5 
NOT COMPLETED   22   15   23   21 
Adverse Event                1                9                12                10 
Death                0                0                2                0 
Lack of Efficacy                17                3                2                3 
Withdrawal by Subject                1                2                4                3 
Lost to Follow-up                3                1                0                2 
Withdraw consent post transition to SOC                0                0                1                1 
Protocol Violation                0                0                0                1 
Physician Decision                0                0                0                1 
Request of withdrawal w/o future contact                0                0                1                0 
Viral rebound outside protocol timepoint                0                0                1                0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group 4: Peginterferon Alfa-2b (1.5 μg/kg)

subcutaneous weekly for 48 weeks

peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

Group 1: Interferon Alfa-2b (Dose 1)

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

Group 2: Interferon Alfa-2b (Dose 2)

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

Group 3: Interferon Alfa-2b (Dose 3)

continuous subcutaneous infusion for 48 weeks

external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b

interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks

ribavirin, USP : All patients will receive oral ribavirin

Total Total of all reporting groups

Baseline Measures
   Group 4: Peginterferon Alfa-2b (1.5 μg/kg)   Group 1: Interferon Alfa-2b (Dose 1)   Group 2: Interferon Alfa-2b (Dose 2)   Group 3: Interferon Alfa-2b (Dose 3)   Total 
Overall Participants Analyzed 
[Units: Participants]
 28   25   27   26   106 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   28   25   27   26   106 
>=65 years   0   0   0   0   0 
Age 
[Units: Years]
Median (Inter-Quartile Range)
 51.2 
 (48.5 to 53.8) 
 51.5 
 (47.0 to 56.1) 
 51.3 
 (46.7 to 55.5) 
 49.1 
 (44.6 to 53.2) 
 51.2 
 (44.6 to 56.1) 
Gender 
[Units: Participants]
         
Female   8   12   11   12   43 
Male   20   13   16   14   63 
Ethnicity (NIH/OMB) 
[Units: Participants]
         
Hispanic or Latino   2   3   3   4   12 
Not Hispanic or Latino   26   22   24   22   94 
Unknown or Not Reported   0   0   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   1   0   0   1   2 
Asian   0   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   1   0   1 
Black or African American   5   2   4   3   14 
White   21   23   22   21   87 
More than one race   1   0   0   1   2 
Unknown or Not Reported   0   0   0   0   0 
Region of Enrollment 
[Units: Participants]
         
United States   28   25   27   26   106 
Hepatitis C Genotype [1] 
[Units: Participants]
         
1a   24   19   23   19   85 
1b   4   6   4   7   21 
[1] 1a, 1b


  Outcome Measures

1.  Primary:   Viral Load: Incidence of Sustained Virologic Response (SVR)   [ Time Frame: 24 weeks after treatment is complete ]

2.  Secondary:   Rapid Virologic Response (RVR)   [ Time Frame: Study Week 4 ]

3.  Secondary:   Early Virologic Response (EVR)   [ Time Frame: Study week 12 ]

4.  Primary:   Safety/Tolerability   [ Time Frame: Through study week 72 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   End-of-treatment Response (EOT)   [ Time Frame: Study week 48 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Pharmacokinetics   [ Time Frame: through Study Week 72 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Pharmacodynamics   [ Time Frame: through Study Week 72 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Functional Health, Depression Score, and Fatigue Level   [ Time Frame: through Study Week 72 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Viral Decay   [ Time Frame: 12 weeks of treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Trial Manager
Organization: Medtronic, Inc.
phone: 763-505-4594
e-mail: sarah.mische@medtronic.com



Responsible Party: Medtronic Corporate Technologies and New Ventures
ClinicalTrials.gov Identifier: NCT00919633     History of Changes
Other Study ID Numbers: 4316001
First Submitted: June 10, 2009
First Posted: June 12, 2009
Results First Submitted: March 28, 2014
Results First Posted: April 30, 2014
Last Update Posted: April 30, 2014