Trial Outcomes & Findings for Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C (NCT NCT00919633)

NCT ID: NCT00919633

Last Updated: 2019-10-09

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

116 participants

Primary outcome timeframe

24 weeks after treatment is complete

Results posted on

2019-10-09

Participant Flow

Enrollment 09-Jun-2009, final subject complete 19-Jun-2012.

210 screened, 116 randomized, 106 received at least 1 dose of study drug.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	28	25	27	26
Overall Study COMPLETED	6	10	4	5
Overall Study NOT COMPLETED	22	15	23	21

Reasons for withdrawal

Reasons for withdrawal
Measure	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
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 Withdrawal by Subject	1	2	4	3
Overall Study Lost to Follow-up	3	1	0	2
Overall Study Withdraw consent post transition to SOC	0	0	1	1
Overall Study Protocol Violation	0	0	0	1
Overall Study Physician Decision	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

Baseline Characteristics

Safety and Efficacy Study to Compare Continuous Infusion of Interferon With Standard of Care for Chronic Hepatitis C

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 4: Peginterferon Alfa-2b (1.5 μg/kg) n=28 Participants 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) n=25 Participants 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) n=27 Participants 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) n=26 Participants 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 n=106 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	25 Participants n=7 Participants	27 Participants n=5 Participants	26 Participants n=4 Participants	106 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	51.2 years n=5 Participants	51.5 years n=7 Participants	51.3 years n=5 Participants	49.1 years n=4 Participants	51.2 years n=21 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	12 Participants n=4 Participants	43 Participants n=21 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	13 Participants n=7 Participants	16 Participants n=5 Participants	14 Participants n=4 Participants	63 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	12 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	22 Participants n=7 Participants	24 Participants n=5 Participants	22 Participants n=4 Participants	94 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	3 Participants n=4 Participants	14 Participants n=21 Participants
Race (NIH/OMB) White	21 Participants n=5 Participants	23 Participants n=7 Participants	22 Participants n=5 Participants	21 Participants n=4 Participants	87 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	28 participants n=5 Participants	25 participants n=7 Participants	27 participants n=5 Participants	26 participants n=4 Participants	106 participants n=21 Participants
Hepatitis C Genotype 1a	24 participants n=5 Participants	19 participants n=7 Participants	23 participants n=5 Participants	19 participants n=4 Participants	85 participants n=21 Participants
Hepatitis C Genotype 1b	4 participants n=5 Participants	6 participants n=7 Participants	4 participants n=5 Participants	7 participants n=4 Participants	21 participants n=21 Participants

PRIMARY outcome

Timeframe: 24 weeks after treatment is complete

Outcome measures

Outcome measures
Measure	Group 4: Peginterferon Alfa-2b (1.5 μg/kg) n=28 Participants 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) n=25 Participants 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) n=27 Participants 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) n=26 Participants 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
Viral Load: Incidence of Sustained Virologic Response (SVR)	4 participants	7 participants	2 participants	4 participants

SECONDARY outcome

Timeframe: Study Week 4

Outcome measures

Outcome measures
Measure	Group 4: Peginterferon Alfa-2b (1.5 μg/kg) n=28 Participants 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) n=25 Participants 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) n=27 Participants 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) n=26 Participants 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
Rapid Virologic Response (RVR)	2 participants	4 participants	7 participants	11 participants

SECONDARY outcome

Timeframe: Study week 12

Outcome measures

Outcome measures
Measure	Group 4: Peginterferon Alfa-2b (1.5 μg/kg) n=28 Participants 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) n=25 Participants 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) n=27 Participants 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) n=26 Participants 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
Early Virologic Response (EVR)	7 participants	15 participants	13 participants	11 participants

Adverse Events

PEGINTRON 1.5

Serious events: 2 serious events

Other events: 28 other events

Deaths: 0 deaths

INTRON A 80,000

Serious events: 6 serious events

Other events: 25 other events

Deaths: 0 deaths

INTRON A 120,000

Serious events: 5 serious events

Other events: 27 other events

Deaths: 0 deaths

INTRON A 160,000

Serious events: 6 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Trial Manager

Medtronic, Inc.

Phone: 763-505-4594

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	PEGINTRON 1.5 n=28 participants at risk 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	INTRON A 80,000 n=25 participants at risk 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	INTRON A 120,000 n=27 participants at risk 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	INTRON A 160,000 n=26 participants at risk 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
Infections and infestations Bronchitis	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	3.8% 1/26 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.
Infections and infestations Cellulitis	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	3.8% 1/26 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.
Infections and infestations Injection Site Cellulitis	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	3.8% 1/26 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.
Infections and infestations Staphylococcal Abscess	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	3.8% 1/26 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.
Infections and infestations Appendicitis	3.6% 1/28 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/26 • Adverse events were collected the duration of the study from activation to closure.
Infections and infestations Pneumonia	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	8.0% 2/25 • Number of events 2 • Adverse events were collected the duration of the study from activation to closure.	7.4% 2/27 • Number of events 2 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/26 • Adverse events were collected the duration of the study from activation to closure.
Infections and infestations Pneumonia Moraxella	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	3.7% 1/27 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/26 • Adverse events were collected the duration of the study from activation to closure.
Infections and infestations Streptococcal Abscess	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	3.7% 1/27 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/26 • Adverse events were collected the duration of the study from activation to closure.
Blood and lymphatic system disorders Anaemia	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	4.0% 1/25 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	3.8% 1/26 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.
Gastrointestinal disorders Vomiting	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	3.8% 1/26 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.
Gastrointestinal disorders Melaena	3.6% 1/28 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/26 • Adverse events were collected the duration of the study from activation to closure.
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	3.8% 1/26 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.
Musculoskeletal and connective tissue disorders Musculoskeletal Chest Pain	3.6% 1/28 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/26 • Adverse events were collected the duration of the study from activation to closure.
Psychiatric disorders Suicidal Ideation	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	3.8% 1/26 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.
Psychiatric disorders Suicide Attempt	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	3.8% 1/26 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.
Cardiac disorders Arteriosclerosis Coronary Artery	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	3.7% 1/27 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/26 • Adverse events were collected the duration of the study from activation to closure.
Cardiac disorders Hypertensive Heart Disease	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	3.7% 1/27 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/26 • Adverse events were collected the duration of the study from activation to closure.
Hepatobiliary disorders Liver Disorder	3.6% 1/28 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/26 • Adverse events were collected the duration of the study from activation to closure.
Metabolism and nutrition disorders Dehydration	3.6% 1/28 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/25 • Adverse events were collected the duration of the study from activation to closure.	3.7% 1/27 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/26 • Adverse events were collected the duration of the study from activation to closure.
Metabolism and nutrition disorders Type 2 Diabetes Mellitus	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	4.0% 1/25 • Number of events 1 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/26 • Adverse events were collected the duration of the study from activation to closure.
Nervous system disorders Syncope	0.00% 0/28 • Adverse events were collected the duration of the study from activation to closure.	8.0% 2/25 • Number of events 2 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/27 • Adverse events were collected the duration of the study from activation to closure.	0.00% 0/26 • Adverse events were collected the duration of the study from activation to closure.