Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00473824
Other study ID # Nabi-3104
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date May 2007
Est. completion date February 2009

Study information

Verified date July 2021
Source ADMA Biologics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Phase 2 study to evaluate safety, pharmacokinetics and efficacy of Hepatitis C Immune Globulin Intravenous (human) [Civacir(TM)] for preventing or reducing the impact of recurrent HCV infection following liver transplantation.


Description:

Hepatitis C virus (HCV) infection is the leading single cause of liver transplantation (LT) in the US and Europe. Recurrence of HCV infection following LT is almost universal. There is currently no effective way to prevent post-transplantation HCV infection of the liver graft and related progression of HCV-related liver disease. This study is designed to evaluate a polyclonal human hepatitis C immune globulin (Civacir) given during and post liver transplantation for preventing or reducing the impact of recurrent HCV infection. In this open-label trial, 2 subjects will be randomized to receive Civacir (standard of care treatment plus Civacir) for every 1 Control subject (standard of care treatment alone). Civacir recipients will receive 18 intravenous infusions over 24 weeks beginning at the time of liver transplantation. Viral loads, liver enzyme assessments and liver biopsy assessments will be made at scheduled intervals during the study which will last for 48 weeks.


Recruitment information / eligibility

Status Terminated
Enrollment 7
Est. completion date February 2009
Est. primary completion date February 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Male or female, 18 to 75 years of age. - Written informed consent. - Expectation of compliance with the protocol procedures. - If female, have a negative pregnancy test within 3 days prior to randomization and use an acceptable method of contraception or be at least one year post-menopausal or surgically sterile. - HCV infection identified by positive, quantifiable HCV-RNA test within 3 months prior to transplantation. - First time liver transplant recipient. - Primary, single organ recipient (deceased donor <65 years of age). - Normal TSH. - Subjects with a pre-LT diagnosis of hepatocellular carcinoma (HCC) may be enrolled provided: there is no evidence of extrahepatic spread, tumor is solitary and <5cm or there are up to three tumors <3 cm. - Agree to receive study medication as outlined in the protocol and follow all study related procedures until the conclusion of their protocol participation. - Agree to consume no alcohol during the entire study period. Exclusion Criteria: - Has received an investigational agent within the last six weeks prior to liver transplantation. Exceptions include Theraspheres for hepatocellular carcinoma or rifaximin. - Known immunoglobulin A deficiency. - Subject weighs more than 112.5 Kg (248 pounds). - Known history of cancer, suspected cancer, or cancer therapy within 12 months prior to the administration of the investigational product, except for treatment for basal cell carcinoma, squamous cell carcinoma, cancer of the cervix in situ, early stage prostate cancer (Gleason's grade 1 or 2), or a history of malignancy where the risk of recurrence is >= 20% within 2 years. A significant exception is hepatocellular carcinoma with predefined acceptability (see inclusion criteria). - Has any condition judged by the study physician to preclude participation in the study, including any psychological disorder, which might hinder compliance. - History of use of immunosuppressive or immunomodulatory drugs within 3 months prior to randomization (except low-dose physiologic replacement glucocorticoid therapy (<=10 mg of prednisone or equivalent per day). - Recipient of liver from a living donor. - Subjects whose liver is obtained from a non-beating heart donor. - Subjects scheduled to receive a split liver transplantation. - Liver transplants that were obtained from donors across ABO incompatible blood type. - Donor liver cold ischemic time greater than 20 hours. - Donor liver is from a hepatitis C positive donor. - Evidence of any other unresolved infection and any unresolved opportunistic infection requiring treatment. - Serum creatinine level >2.0 times the upper limit of normal or advanced renal disease at screening. - Neutrophil count <1500 cells/mm3, WBC>20,000 x 109/L, Hgb <8 g/dL, or platelet count <25,000 cells/mm3. - Planned use of T-cell depleting antibody therapies. - Hepatitis B (sAg, cAb IgM), hepatitis A (IgM) or HIV infection. - History of autoimmune disease (SLE, scleroderma, RA, etc.). - Women who are pregnant or breast feeding. - The use of colony stimulating factor agents to facilitate subject's entry into study within 2 weeks of enrollment. - History of severe psychiatric disease, especially depression. - Seizure disorders uncontrolled by anticonvulsants (within the last 12 mos). - History of severe cardiac disease, unhealed gastric or duodenal ulcer, or other significant medical disease that would put the subject at risk from the volume of the infusions or significant risk of bleeding from the underlying condition. - Evidence of alcohol and/or drug abuse within 6 months of entry or inability/unwilling-ness to abstain from alcohol throughout entire course of treatment and follow-up. - Concomitant medication with rifabutin, pyrazinamide, isoniazid, thalidomide, oxymetholone (Anadrol). - History of thyroid disease poorly controlled on prescribed medications. - History or other evidence of severe illness or any other conditions which would make the subject, in the opinion of the investigator, unsuitable for Civacir treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Hepatitis C Immune Globulin Intravenous (Human) 5%
Hepatitis C Immune Globulin Intravenous (Human) 5%, [Civacir]: 18 infusions total, per schedule, of 300 or 400 mg/kg of body weight given with standard post-transplant therapy inclusive of immunosuppressive agents.

Locations

Country Name City State
United States Mayo Clinic Jacksonville Florida
United States Mayo Clinic Phoenix Arizona
United States Mayo Clinic Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
ADMA Biologics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Post Transplant Reduction in Viral Load (as Measured Quantitatively by Hepatitis C Virus (HCV) Reverse Transcription-Polymerase Chain Reaction (HCV RT-PCR)). 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 evaluations at 1 month (Day 28) and 6 months ( 24 weeks) post-tranplant.
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05047406 - Bacillus Clausii in Liver Transplantation Phase 2
Completed NCT02463214 - Prevention of Healthcare Associated Infections in Bone Marrow Transplant Patients N/A
Recruiting NCT05198570 - Pharmacokinetics of Intravenous Acyclovir in Oncologic Paediatric Patients
Completed NCT01808456 - Standard-dose Versus High-dose Flu Vaccine in Solid Organ Transplant. Phase 4
Suspended NCT01301118 - Graft Take and Microbiology in Burns N/A
Completed NCT00610961 - Induction Related BK Viremia in Renal Transplant Patients Phase 4
Recruiting NCT05215327 - High vs. Standard Dose Influenza Vaccine in Lung Allograft Recipients Phase 2
Recruiting NCT05193058 - Description of Lung Transplant Patients With Microbiologically Documented Stenotrophomonas Maltophilia Pneumonia and Impact of Treatment on Outcome
Unknown status NCT01983761 - Study of ASC-101 in Patients With Hematologic Malignancies Who Receive Dual-cord Umbilical Cord Blood Transplantation Phase 1/Phase 2
Active, not recruiting NCT02811835 - TransplantLines Food and Nutrition Biobank and Cohort Study (TxL-FN) N/A
Completed NCT01471444 - Fludarabine-IV Busulfan ± Clofarabine and Allogeneic Hematopoietic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) Phase 3
Enrolling by invitation NCT01349738 - Asymptomatic Bacteriuria & Risk of Urinary Tract Infection in Renal Transplants N/A
Completed NCT00177801 - Organ Transplant Infection Prevention and Detection Project Phase 4
Completed NCT01276457 - Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients Phase 3
Completed NCT02328963 - Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection When Treated With an Immunosuppressive Regimen Including Everolimus and Reduced Dose of Cyclosporine Versus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A Phase 4
Recruiting NCT04320303 - CMV Infection and Immune Intervention After Transplantation N/A
Active, not recruiting NCT01295645 - Cidofovir Versus Best Supportive Care for Hemorrhagic Cystitis Phase 2
Completed NCT02329808 - Clinical Validation of a Dried Blood Spot Method for Analysis of Immunosuppressives and Antifungals in Pediatrics
Completed NCT01471067 - Cord Blood Fucosylation to Enhance Homing and Engraftment in Patients With Hematologic Malignancies Phase 1
Recruiting NCT04579471 - Prevalence and Outcome of SARS-CoV-2 Infection & COVID-19 in Transplant Recipients: The COVITRA Study