Trial Outcomes & Findings for Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation (NCT NCT00473824)
NCT ID: NCT00473824
Last Updated: 2021-07-30
Results Overview
Percentage of subjects who achieve reduction in viral load from the baseline pre-transplant value. Baseline is the pre-transplant HCV viral load as measeured by RT-PCR. Post-transplant HCV viral load is determined at both 1 month and 6 months post-tranplant.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Outcome evaluations at 1 month (Day 28) and 6 months ( 24 weeks) post-tranplant.
Results posted on
2021-07-30
Participant Flow
First enrollment: 14 May 2007 Last Subject completed: 16 February 2009 Three investigative sites, all Mayo Clinics
This was an open label, randomized study.
Participant milestones
| Measure |
No Civacir (Control)
Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
|
Civacir Treatment Arm
Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% \[Civacir\], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
5
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
| Measure |
No Civacir (Control)
Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
|
Civacir Treatment Arm
Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% \[Civacir\], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
|
|---|---|---|
|
Overall Study
Virologic Breakthrough
|
0
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by physician
|
0
|
1
|
Baseline Characteristics
Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation
Baseline characteristics by cohort
| Measure |
Civacir Treatment Arm
n=5 Participants
Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% \[Civacir\], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
|
No Civacir (Control)
n=2 Participants
Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
|
Total
n=7 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
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 5.0 • n=5 Participants
|
47 years
STANDARD_DEVIATION 11.3 • n=7 Participants
|
50 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
2 participants
n=7 Participants
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Outcome evaluations at 1 month (Day 28) and 6 months ( 24 weeks) post-tranplant.Population: As the study was terminated early and since no participant in either arm achieved reduction in viral load, it was recorded that zero particpants and zero percent in each arm achieved reduction in viral load.
Percentage of subjects who achieve reduction in viral load from the baseline pre-transplant value. Baseline is the pre-transplant HCV viral load as measeured by RT-PCR. Post-transplant HCV viral load is determined at both 1 month and 6 months post-tranplant.
Outcome measures
| Measure |
Civacir Treatment Arm
n=5 Participants
Subjects received Hepatitis C Immune Globulin Intravenous (Human) 5% \[Civacir\], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight, in addition to their standard site specific routine post-tranplant immunosuppressant therapy.
|
No Civacir (Control)
n=2 Participants
Observation on standard site specific routine post-tranplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%. Standard post-tranplant therapy includes immunosuppressive agents.
|
|---|---|---|
|
Post Transplant Reduction in Viral Load (as Measured Quantitatively by Hepatitis C Virus (HCV) Reverse Transcription-Polymerase Chain Reaction (HCV RT-PCR)).
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Civacir Treatment Arm
Serious events: 4 serious events
Other events: 4 other events
Deaths: 0 deaths
No Civacir (Control)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Civacir Treatment Arm
n=5 participants at risk
Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% \[Civacir\], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
|
No Civacir (Control)
n=2 participants at risk
Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome [ARDS]
|
20.0%
1/5 • Number of events 1
|
0.00%
0/2
|
|
General disorders
Chest Tightness
|
20.0%
1/5 • Number of events 1
|
0.00%
0/2
|
|
Surgical and medical procedures
Mid Common Hepatic Ductal Stricture with possible Biliary Leak
|
20.0%
1/5 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
Vancomycin-Resistant Enterococcus Bacteremia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
Osteomyelitis
|
20.0%
1/5 • Number of events 1
|
0.00%
0/2
|
|
Infections and infestations
Methicillin-resistant staph aureus (MRSA) Peritonitis
|
20.0%
1/5 • Number of events 1
|
0.00%
0/2
|
|
Cardiac disorders
Hyperkalemia
|
20.0%
1/5 • Number of events 1
|
0.00%
0/2
|
Other adverse events
| Measure |
Civacir Treatment Arm
n=5 participants at risk
Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% \[Civacir\], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
|
No Civacir (Control)
n=2 participants at risk
Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
|
|---|---|---|
|
Blood and lymphatic system disorders
Blood and Lymphatic System Disorders
|
20.0%
1/5 • Number of events 2
|
100.0%
2/2 • Number of events 2
|
|
Cardiac disorders
Cardiac Disorders
|
20.0%
1/5 • Number of events 1
|
0.00%
0/2
|
|
Eye disorders
Eye Disorders
|
0.00%
0/5
|
50.0%
1/2 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Disorders
|
60.0%
3/5 • Number of events 14
|
100.0%
2/2 • Number of events 8
|
|
General disorders
General Disorders and Administration Site Conditions
|
60.0%
3/5 • Number of events 3
|
50.0%
1/2 • Number of events 4
|
|
Hepatobiliary disorders
Hepatobiliary Disorders
|
0.00%
0/5
|
50.0%
1/2 • Number of events 1
|
|
Renal and urinary disorders
Infections and Infestations
|
20.0%
1/5 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Injury, poisoning and procedural complications
Injury, Poisoning and Procedural Complications
|
40.0%
2/5 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
|
Investigations
Investigations
|
0.00%
0/5
|
50.0%
1/2 • Number of events 1
|
|
Metabolism and nutrition disorders
Metabolism and Nutrition Disorders
|
60.0%
3/5 • Number of events 6
|
100.0%
2/2 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and Connective Tissue Disorders
|
40.0%
2/5 • Number of events 3
|
100.0%
2/2 • Number of events 4
|
|
Nervous system disorders
Nervous System Disorders
|
40.0%
2/5 • Number of events 4
|
100.0%
2/2 • Number of events 3
|
|
Psychiatric disorders
Psychiatric Disorders
|
60.0%
3/5 • Number of events 3
|
100.0%
2/2 • Number of events 4
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
20.0%
1/5 • Number of events 2
|
100.0%
2/2 • Number of events 2
|
|
Reproductive system and breast disorders
Reproductive System and Breast Disorders
|
20.0%
1/5 • Number of events 1
|
50.0%
1/2 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic and Mediastinal Disorders
|
0.00%
0/5
|
50.0%
1/2 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin and Subcutaneous Tissue Disorders
|
20.0%
1/5 • Number of events 1
|
0.00%
0/2
|
|
Vascular disorders
Vascular Disorders
|
40.0%
2/5 • Number of events 2
|
50.0%
1/2 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60