Clinical trial · Interventional
Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients.
A Multi-Center, Randomized, Prospective, Open-Label Phase III Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Hepatitis C Immune Globulin Intravenous (Human), Civacir®, in Orthotopic Liver Transplant Recipients
NCT01804829CI-TRIAL-00026477completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to test the safety and efficacy of Civacir® to prevent the recurrence of Hepatitis C Virus (HCV) after liver transplant.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis C Infection | — | UNRESOLVED | — |
| Hepatitis, Viral, Human | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cirrhosis | — | UNRESOLVED | — |
| Viruses | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Civacir® 10% | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Observational Control
- description
- Subjects who attain HCV RNA \<100 IU/ml and are randomized to the control arm will receive standard post-transplant immunosuppressant therapy and be followed for a 34 week period.
- type
- EXPERIMENTAL
- label
- Civacir® 10% at 200 mg/kg dose
- description
- Subjects who attain HCV RNA \<100 IU/ml and are randomized to the Civacir 200 mg/kg treatment arm will receive Civacir® before liver transplant, followed by 15 infusions over a 10 week regimen, with standard post-transplant immunosuppressant therapy. Civacir® treated subjects will be followed up to 34 weeks post-transplant.
- interventionNames
- Biological: Civacir® 10%
- type
- EXPERIMENTAL
- label
- Civacir® 10% at 300 mg/kg dose
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Written informed consent obtained prior to any study-specific assessments and within 3 months (reconsent) of orthotopic liver transplantation (OLT). * HCV Genotype 1 through 6 Infection. * Subjects in the beginning of a new antiviral therapy regimen (regardless of prior treatment failures) for up to and including 24 weeks prior to the day of OLT. * Most recent evidence within the last 4 weeks that HCV RNA is \<100 IU/mL. Subjects may be randomized based on local lab HCV RNA. * Male and female subjects (age 18-80 years). * Subject weight under 250 pounds. * Stable patient in a condition which in the opinion of the investigator would permit safe participation in the study. Exclusion Criteria: * Re-transplantation due to viral recurrence. * Positive HIV or HBV test within 90 days prior to transplantation. * Most recent PCR test indicating HCV RNA ≥100 IU/mL within 4 weeks of OLT. * Subjects having received organs from HCV positive donors. * Serum creatinine level \>2.5 times the upper limit of normal or advanced renal disease at screening. * Pregnancy or single contraceptive measure or lactation period (females only). * Known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction). * Known absolute Immunoglobulin A (IgA) deficiency. * Known intolerance to proteins of human origin. * Participation in another clinical trial within 90 days before signing Informed Consent Form (ICF) or during the study (observational/ non-interventional and 988 studies allowed), and/or previous participation in 988 study (except for Study 988 screen failures). * Active drug and/or alcohol abuse. * Inability or lacking motivation to participate in the study.
References
Publications (2)
- BACKGROUNDEverson GT, Terrault NA, Lok AS, Rodrigo del R, Brown RS Jr, Saab S, Shiffman ML, Al-Osaimi AM, Kulik LM, Gillespie BW, Everhart JE; Adult-to-Adult Living Donor Liver Transplantation Cohort Study. A randomized controlled trial of pretransplant antiviral therapy to prevent recurrence of hepatitis C after liver transplantation. Hepatology. 2013 May;57(5):1752-62. doi: 10.1002/hep.25976. Epub 2013 Jan 17. PMID 22821361
- BACKGROUNDDavis GL, Nelson DR, Terrault N, Pruett TL, Schiano TD, Fletcher CV, Sapan CV, Riser LN, Li Y, Whitley RJ, Gnann JW Jr; Collaborative Antiviral Study Group. A randomized, open-label study to evaluate the safety and pharmacokinetics of human hepatitis C immune globulin (Civacir) in liver transplant recipients. Liver Transpl. 2005 Aug;11(8):941-9. doi: 10.1002/lt.20405. PMID 16035063