Trial Outcomes & Findings for Infliximab Treatment Along With Pegylated Interferon and Ribavirin in the Treatment of Hepatitis C (NCT NCT00512278)
NCT ID: NCT00512278
Last Updated: 2017-09-13
Results Overview
A comparison of the Proportion of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of TreatmentSVR in both study arms
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
146 participants
Primary outcome timeframe
72 Weeks from initiation of treatment
Results posted on
2017-09-13
Participant Flow
Enrollment 2007-2011 Data Lock Nov 22, 2012 Sites 1. The Cleveland Clinic 2. University Hospitals of Cleveland 3. Cedar Sinai Medical Center, Los Angeles, 4. The Liver Institute at Methodist Dallas 5. Brooke Army Medical Center, San Antonio 6. Advanced Medical Research Center, Daytona Beach. 7. University of Louisville, Louisville
220 subjects screened and 149 randomized Reasons for exclusion were multiple including malignancy, liver failure, negative HCV RNA, abnormal lab values, poorly controlled diabetes, psych disorders, positive tuberculosis skin test, seizure disorder, inability to get labs or liver biopsy, pregnancy, patient declining, other (cardiomypathy, MS, etc.)
Participant milestones
| Measure |
A Infliximab
Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab
Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses
|
B Placebo
Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV
Placebo : Placebo
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed similar to infliximab for patients in arm A of the study
|
|---|---|---|
|
Overall Study
STARTED
|
73
|
73
|
|
Overall Study
COMPLETED
|
45
|
56
|
|
Overall Study
NOT COMPLETED
|
28
|
17
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Infliximab Treatment Along With Pegylated Interferon and Ribavirin in the Treatment of Hepatitis C
Baseline characteristics by cohort
| Measure |
A Infliximab
n=73 Participants
Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab
Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses
|
B Placebo
n=73 Participants
Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV
Placebo : Placebo
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed similar to infliximab for patients in arm A of the study
|
Total
n=146 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
73 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
46.7 years
STANDARD_DEVIATION 9.78 • n=99 Participants
|
47.2 years
STANDARD_DEVIATION 9.38 • n=107 Participants
|
46.9 years
STANDARD_DEVIATION 9.58 • n=206 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=99 Participants
|
73 participants
n=107 Participants
|
146 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 72 Weeks from initiation of treatmentPopulation: Included all patients who received at least one dose of treatment in both study arms
A comparison of the Proportion of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of TreatmentSVR in both study arms
Outcome measures
| Measure |
A Infliximab
n=73 Participants
Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab
Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses
|
B Placebo
n=73 Participants
Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV
Placebo : Placebo
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed similar to infliximab for patients in arm A of the study
|
|---|---|---|
|
A Comparison of the Percentage of Chronic Hepatitis C Subjects (Treatment Naive,Genotype 1) Who Achieve SVR at Week 72, After 48 Weeks of Treatment.
|
28.8 percentage of participants
|
31.5 percentage of participants
|
PRIMARY outcome
Timeframe: 24 weeks after completion of all study medicationsHCV RNA negativity at 24 weeks after completion of all study medications
Outcome measures
| Measure |
A Infliximab
n=73 Participants
Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab
Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses
|
B Placebo
n=73 Participants
Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV
Placebo : Placebo
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed similar to infliximab for patients in arm A of the study
|
|---|---|---|
|
Number of Participants Achieving Sustained Virological Response (SVR)
|
21 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: 24 weeksA comparison of the proportion of the subject population with non-detectable HCV-RNA after 24 wks of therapy.
Outcome measures
| Measure |
A Infliximab
n=73 Participants
Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab
Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses
|
B Placebo
n=73 Participants
Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV
Placebo : Placebo
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed similar to infliximab for patients in arm A of the study
|
|---|---|---|
|
A Comparison of the Percentage of Participants With Non-detectable HCV-RNA After 24 Weeks of Therapy.
|
40 Participants
|
41 Participants
|
SECONDARY outcome
Timeframe: 72 Weeks from initiation of treatmentThe severity of adverse events was graded according to modified World Health Organization grades as mild, moderate, severe, or life-threatening
Outcome measures
| Measure |
A Infliximab
n=73 Participants
Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab
Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses
|
B Placebo
n=73 Participants
Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV
Placebo : Placebo
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed similar to infliximab for patients in arm A of the study
|
|---|---|---|
|
Percentage of Participants Experiencing Serious Adverse Events
|
21 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 72 weeks from initiation of treatmentMedically significant infection was defined as an infection requiring the use of intravenous antibiotics or hospitalization.
Outcome measures
| Measure |
A Infliximab
n=73 Participants
Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab
Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses
|
B Placebo
n=73 Participants
Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV
Placebo : Placebo
All patients received triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed similar to infliximab for patients in arm A of the study
|
|---|---|---|
|
Percentage of Participants Experiencing Medically Significant Infections
|
10 Participants
|
3 Participants
|
Adverse Events
A Infliximab
Serious events: 21 serious events
Other events: 73 other events
Deaths: 0 deaths
B Placebo
Serious events: 13 serious events
Other events: 73 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
A Infliximab
n=73 participants at risk
Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab
Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses
|
B Placebo
n=73 participants at risk
Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV
Placebo : Placebo
All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed simialr to infliximab for patients in arm A of the study
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
5.5%
4/73 • 72 weeks
|
2.7%
2/73 • 72 weeks
|
|
Infections and infestations
Medically Significant Infections
|
13.7%
10/73 • 72 weeks
|
4.1%
3/73 • 72 weeks
|
|
Nervous system disorders
Coordination Abnormal
|
0.00%
0/73 • 72 weeks
|
1.4%
1/73 • 72 weeks
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/73 • 72 weeks
|
1.4%
1/73 • 72 weeks
|
|
Nervous system disorders
Headache
|
0.00%
0/73 • 72 weeks
|
1.4%
1/73 • 72 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/73 • 72 weeks
|
1.4%
1/73 • 72 weeks
|
|
Psychiatric disorders
Suicidal Ideation
|
1.4%
1/73 • 72 weeks
|
4.1%
3/73 • 72 weeks
|
|
General disorders
Severe Dehydration
|
4.1%
3/73 • 72 weeks
|
1.4%
1/73 • 72 weeks
|
|
Vascular disorders
Deep Vein Thrombosis
|
1.4%
1/73 • 72 weeks
|
0.00%
0/73 • 72 weeks
|
|
Cardiac disorders
Myocardial Infarction
|
1.4%
1/73 • 72 weeks
|
0.00%
0/73 • 72 weeks
|
|
General disorders
Chest Pain
|
1.4%
1/73 • 72 weeks
|
0.00%
0/73 • 72 weeks
|
Other adverse events
| Measure |
A Infliximab
n=73 participants at risk
Infliximab: 48 weeks of therapy with the combination of PEG INF-2b/RBV plus adjuvant infliximab
Infliximab : Infliximab weight based injection at baseline, weeks 2,6,14,22,30,38,46
All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/infliximab) at approved doses
|
B Placebo
n=73 participants at risk
Placebo: 48 weeks of therapy with Placebo and PEG INF-2b/RBV
Placebo : Placebo
All patients recieved triple therapy (pegylated interferon (PEG IFN)/ribavirin/placebo) at approved doses. Placebo infusions were timed simialr to infliximab for patients in arm A of the study
|
|---|---|---|
|
General disorders
Fatigue
|
75.3%
55/73 • 72 weeks
|
74.0%
54/73 • 72 weeks
|
|
General disorders
Influenza-Like Illness
|
31.5%
23/73 • 72 weeks
|
23.3%
17/73 • 72 weeks
|
|
General disorders
Irritability
|
27.4%
20/73 • 72 weeks
|
28.8%
21/73 • 72 weeks
|
|
General disorders
Pyrexia
|
28.8%
21/73 • 72 weeks
|
35.6%
26/73 • 72 weeks
|
|
General disorders
Chills
|
17.8%
13/73 • 72 weeks
|
38.4%
28/73 • 72 weeks
|
|
Gastrointestinal disorders
Nausea
|
49.3%
36/73 • 72 weeks
|
56.2%
41/73 • 72 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
15.1%
11/73 • 72 weeks
|
31.5%
23/73 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.1%
22/73 • 72 weeks
|
35.6%
26/73 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
39.7%
29/73 • 72 weeks
|
31.5%
23/73 • 72 weeks
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
24.7%
18/73 • 72 weeks
|
23.3%
17/73 • 72 weeks
|
|
Infections and infestations
Any Infection
|
65.8%
48/73 • 72 weeks
|
57.5%
42/73 • 72 weeks
|
|
Nervous system disorders
Headache
|
57.5%
42/73 • 72 weeks
|
53.4%
39/73 • 72 weeks
|
|
Nervous system disorders
Dizziness
|
19.2%
14/73 • 72 weeks
|
21.9%
16/73 • 72 weeks
|
|
Psychiatric disorders
Insomnia
|
42.5%
31/73 • 72 weeks
|
37.0%
27/73 • 72 weeks
|
|
Psychiatric disorders
Depression
|
28.8%
21/73 • 72 weeks
|
34.2%
25/73 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
32.9%
24/73 • 72 weeks
|
30.1%
22/73 • 72 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
53.4%
39/73 • 72 weeks
|
34.2%
25/73 • 72 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.9%
16/73 • 72 weeks
|
37.0%
27/73 • 72 weeks
|
|
Blood and lymphatic system disorders
Anemia
|
26.0%
19/73 • 72 weeks
|
26.0%
19/73 • 72 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.7%
10/73 • 72 weeks
|
8.2%
6/73 • 72 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place