Hepatitis C
Conditions
Keywords
hepatitis C, HCV, genotype, sustained virological response, rapid virological response, interferon
Brief 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.
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.
Interventions
DRUGinterferon alfa-2b
subcutaneous continuous infusion at one of three doses for 48 weeks
DRUGpeginterferon alfa-2b
1.5 μg/kg subcutaneous weekly for 48 weeks
DRUGribavirin, USP
All patients will receive oral ribavirin
DEVICEexternal drug infusion pump
pump delivery system for continuous subcutaneous infusion of interferon alfa-2b
Sponsors
Medtronic Corporate Technologies and New Ventures
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Viral Load: Incidence of Sustained Virologic Response (SVR) | 24 weeks after treatment is complete |
Secondary
| Measure | Time frame |
|---|---|
| Rapid Virologic Response (RVR) | Study Week 4 |
| Early Virologic Response (EVR) | Study week 12 |
Countries
United States
Participant flow
Recruitment details
Enrollment 09-Jun-2009, final subject complete 19-Jun-2012.
Pre-assignment details
210 screened, 116 randomized, 106 received at least 1 dose of study drug.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 28 |
| 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 | 25 |
| 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 | 27 |
| 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 | 26 |
| Total | 106 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 9 | 12 | 10 |
| Overall Study | Death | 0 | 0 | 2 | 0 |
| Overall Study | Lack of Efficacy | 17 | 3 | 2 | 3 |
| Overall Study | Lost to Follow-up | 3 | 1 | 0 | 2 |
| Overall Study | Physician Decision | 0 | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
| Overall Study | Request of withdrawal w/o future contact | 0 | 0 | 1 | 0 |
| Overall Study | Viral rebound outside protocol timepoint | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 4 | 3 |
| Overall Study | Withdraw consent post transition to SOC | 0 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Group 1: Interferon Alfa-2b (Dose 1) | Group 2: Interferon Alfa-2b (Dose 2) | Group 4: Peginterferon Alfa-2b (1.5 μg/kg) | Group 3: Interferon Alfa-2b (Dose 3) | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 27 Participants | 28 Participants | 26 Participants | 106 Participants |
| Age, Continuous | 51.5 years | 51.3 years | 51.2 years | 49.1 years | 51.2 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 3 Participants | 2 Participants | 4 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 22 Participants | 24 Participants | 26 Participants | 22 Participants | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Hepatitis C Genotype 1a | 19 participants | 23 participants | 24 participants | 19 participants | 85 participants |
| Hepatitis C Genotype 1b | 6 participants | 4 participants | 4 participants | 7 participants | 21 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 4 Participants | 5 Participants | 3 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 23 Participants | 22 Participants | 21 Participants | 21 Participants | 87 Participants |
| Region of Enrollment United States | 25 participants | 27 participants | 28 participants | 26 participants | 106 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 8 Participants | 12 Participants | 43 Participants |
| Sex: Female, Male Male | 13 Participants | 16 Participants | 20 Participants | 14 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 28 / 28 | 25 / 25 | 27 / 27 | 26 / 26 |
| serious Total, serious adverse events | 2 / 28 | 6 / 25 | 5 / 27 | 6 / 26 |
Outcome results
Primary
Viral Load: Incidence of Sustained Virologic Response (SVR)
Time frame: 24 weeks after treatment is complete
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 4: Peginterferon Alfa-2b (1.5 μg/kg) | Viral Load: Incidence of Sustained Virologic Response (SVR) | 4 participants |
| Group 1: Interferon Alfa-2b (Dose 1) | Viral Load: Incidence of Sustained Virologic Response (SVR) | 7 participants |
| Group 2: Interferon Alfa-2b (Dose 2) | Viral Load: Incidence of Sustained Virologic Response (SVR) | 2 participants |
| Group 3: Interferon Alfa-2b (Dose 3) | Viral Load: Incidence of Sustained Virologic Response (SVR) | 4 participants |
Secondary
Early Virologic Response (EVR)
Time frame: Study week 12
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 4: Peginterferon Alfa-2b (1.5 μg/kg) | Early Virologic Response (EVR) | 7 participants |
| Group 1: Interferon Alfa-2b (Dose 1) | Early Virologic Response (EVR) | 15 participants |
| Group 2: Interferon Alfa-2b (Dose 2) | Early Virologic Response (EVR) | 13 participants |
| Group 3: Interferon Alfa-2b (Dose 3) | Early Virologic Response (EVR) | 11 participants |
Secondary
Rapid Virologic Response (RVR)
Time frame: Study Week 4
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 4: Peginterferon Alfa-2b (1.5 μg/kg) | Rapid Virologic Response (RVR) | 2 participants |
| Group 1: Interferon Alfa-2b (Dose 1) | Rapid Virologic Response (RVR) | 4 participants |
| Group 2: Interferon Alfa-2b (Dose 2) | Rapid Virologic Response (RVR) | 7 participants |
| Group 3: Interferon Alfa-2b (Dose 3) | Rapid Virologic Response (RVR) | 11 participants |