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Trial record 88 of 2128 for:    Hepatitis C

Infliximab Treatment Along With Pegylated Interferon and Ribavirin in the Treatment of Hepatitis C (PARTNER)

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ClinicalTrials.gov Identifier: NCT00512278
Recruitment Status : Completed
First Posted : August 7, 2007
Results First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Collaborator:
Centocor, Inc.
Information provided by (Responsible Party):
Nizar Zein, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C
Interventions Drug: Infliximab
Drug: Placebo
Enrollment 146
Recruitment Details

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
Pre-assignment Details 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.)
Arm/Group Title A Infliximab B Placebo
Hide Arm/Group Description

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

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

Period Title: Overall Study
Started 73 73
Completed 45 56
Not Completed 28 17
Arm/Group Title A Infliximab B Placebo Total
Hide Arm/Group Description

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

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 of all reporting groups
Overall Number of Baseline Participants 73 73 146
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 73 participants 146 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
73
 100.0%
73
 100.0%
146
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 73 participants 73 participants 146 participants
46.7  (9.78) 47.2  (9.38) 46.9  (9.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 73 participants 73 participants 146 participants
Female
33
  45.2%
31
  42.5%
64
  43.8%
Male
40
  54.8%
42
  57.5%
82
  56.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 73 participants 73 participants 146 participants
73 73 146
1.Primary Outcome
Title 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.
Hide Description 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
Time Frame 72 Weeks from initiation of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
Included all patients who received at least one dose of treatment in both study arms
Arm/Group Title A Infliximab B Placebo
Hide Arm/Group Description:

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

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 Number of Participants Analyzed 73 73
Measure Type: Number
Unit of Measure: percentage of participants
28.8 31.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A Infliximab, B Placebo
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated
Statistical Test of Hypothesis P-Value 0.718
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
2.Primary Outcome
Title Number of Participants Achieving Sustained Virological Response (SVR)
Hide Description HCV RNA negativity at 24 weeks after completion of all study medications
Time Frame 24 weeks after completion of all study medications
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Infliximab B Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 73 73
Measure Type: Count of Participants
Unit of Measure: Participants
21
  28.8%
23
  31.5%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A Infliximab, B Placebo
Comments SVR was the primary outcome to calculate sample size. Assuming a 25% difference in the rate of SVR between the the two groups, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated. This analysis included patients randomized and received at least one dose of study drugs. A 2-sided probability value of < 0.05 was considered statistically significant. Univariate and multivariable logistic regression were used for factors associated with an SVR.
Type of Statistical Test Non-Inferiority or Equivalence
Comments Assuming a 25% difference in the rate of SVR between the PEG INF/RBV plus infliximab group (70%) and the PEG INF/RBV (45%) group, a power of 0.85 and an alpha level of 0.05, 75 patients for each group was estimated.
Statistical Test of Hypothesis P-Value 0.718
Comments Univariate and multivariable logistic regression were used for factors associated with an SVR.
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title A Comparison of the Percentage of Participants With Non-detectable HCV-RNA After 24 Weeks of Therapy.
Hide Description A comparison of the proportion of the subject population with non-detectable HCV-RNA after 24 wks of therapy.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Infliximab B Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 73 73
Measure Type: Count of Participants
Unit of Measure: Participants
40
  54.8%
41
  56.2%
4.Secondary Outcome
Title Percentage of Participants Experiencing Serious Adverse Events
Hide Description The severity of adverse events was graded according to modified World Health Organization grades as mild, moderate, severe, or life-threatening
Time Frame 72 Weeks from initiation of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Infliximab B Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 73 73
Measure Type: Count of Participants
Unit of Measure: Participants
21
  28.8%
13
  17.8%
5.Secondary Outcome
Title Percentage of Participants Experiencing Medically Significant Infections
Hide Description Medically significant infection was defined as an infection requiring the use of intravenous antibiotics or hospitalization.
Time Frame 72 weeks from initiation of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A Infliximab B Placebo
Hide Arm/Group Description:

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

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

Overall Number of Participants Analyzed 73 73
Measure Type: Count of Participants
Unit of Measure: Participants
10
  13.7%
3
   4.1%
Time Frame 72 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A Infliximab B Placebo
Hide Arm/Group Description

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

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

All-Cause Mortality
A Infliximab B Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/73 (0.00%)   1/73 (1.37%) 
Show Serious Adverse Events Hide Serious Adverse Events
A Infliximab B Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   21/73 (28.77%)   13/73 (17.81%) 
Blood and lymphatic system disorders     
Anemia * [1]  4/73 (5.48%)  2/73 (2.74%) 
Cardiac disorders     
Myocardial Infarction *  1/73 (1.37%)  0/73 (0.00%) 
General disorders     
Severe Dehydration *  3/73 (4.11%)  1/73 (1.37%) 
Chest Pain * [2]  1/73 (1.37%)  0/73 (0.00%) 
Infections and infestations     
Medically Significant Infections *  10/73 (13.70%)  3/73 (4.11%) 
Nervous system disorders     
Coordination Abnormal *  0/73 (0.00%)  1/73 (1.37%) 
Depressed level of consciousness *  0/73 (0.00%)  1/73 (1.37%) 
Headache *  0/73 (0.00%)  1/73 (1.37%) 
Psychiatric disorders     
Depression *  0/73 (0.00%)  1/73 (1.37%) 
Suicidal Ideation *  1/73 (1.37%)  3/73 (4.11%) 
Vascular disorders     
Deep Vein Thrombosis *  1/73 (1.37%)  0/73 (0.00%) 
*
Indicates events were collected by non-systematic assessment
[1]
hemoglobin less than 8.5g/dL
[2]
Etiology not determined.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
A Infliximab B Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   73/73 (100.00%)   73/73 (100.00%) 
Blood and lymphatic system disorders     
Anemia *  19/73 (26.03%)  19/73 (26.03%) 
Neutropenia *  10/73 (13.70%)  6/73 (8.22%) 
Gastrointestinal disorders     
Nausea *  36/73 (49.32%)  41/73 (56.16%) 
Diarrhea *  11/73 (15.07%)  23/73 (31.51%) 
General disorders     
Fatigue *  55/73 (75.34%)  54/73 (73.97%) 
Influenza-Like Illness *  23/73 (31.51%)  17/73 (23.29%) 
Irritability *  20/73 (27.40%)  21/73 (28.77%) 
Pyrexia *  21/73 (28.77%)  26/73 (35.62%) 
Chills *  13/73 (17.81%)  28/73 (38.36%) 
Infections and infestations     
Any Infection *  48/73 (65.75%)  42/73 (57.53%) 
Musculoskeletal and connective tissue disorders     
Myalgia *  24/73 (32.88%)  22/73 (30.14%) 
Arthralgia *  39/73 (53.42%)  25/73 (34.25%) 
Nervous system disorders     
Headache *  42/73 (57.53%)  39/73 (53.42%) 
Dizziness *  14/73 (19.18%)  16/73 (21.92%) 
Psychiatric disorders     
Insomnia *  31/73 (42.47%)  27/73 (36.99%) 
Depression *  21/73 (28.77%)  25/73 (34.25%) 
Respiratory, thoracic and mediastinal disorders     
Cough *  16/73 (21.92%)  27/73 (36.99%) 
Skin and subcutaneous tissue disorders     
Pruritus *  22/73 (30.14%)  26/73 (35.62%) 
Rash *  29/73 (39.73%)  23/73 (31.51%) 
Alopecia *  18/73 (24.66%)  17/73 (23.29%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Nizar Zein
Organization: Cleveland Clinic
Phone: 216-444-6126
EMail: zeinn@ccf.org
Responsible Party: Nizar Zein, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00512278     History of Changes
Other Study ID Numbers: PARTNER
First Submitted: August 3, 2007
First Posted: August 7, 2007
Results First Submitted: March 31, 2017
Results First Posted: September 13, 2017
Last Update Posted: September 13, 2017