Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation

NCT00473824 | Terminated Phase 2 Results

• 1 other identifier: Nabi-3104
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Sequelae of Viral Hepatitis; Transplantation Infection; Evidence of Liver Transplantation

Keywords

hepatitis C; liver transplantation; immune globulin

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Civacir Treated

EXPERIMENTAL

Hepatitis C Immune Globulin Intravenous (Human) 5% \[Civacir\], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight, with standard post-transplant site specific routine immunosuppressant therapy .

Biological: Hepatitis C Immune Globulin Intravenous (Human) 5%

Observational Control

NO INTERVENTION

Observation on standard post-transplant site specific routine immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5% \[Civacir\].

Interventions

Hepatitis C Immune Globulin Intravenous (Human) 5% BIOLOGICAL

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.

Also known as: Civacir™

Civacir Treated

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• ADMA Biologics, Inc.: lead

Study Sites (3)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

hepatitis C immune globulin, human

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Limitations and Caveats

Early termination by sponsor due to data from the initial 7 patients of 36 planned for this study. Therefore, statistical analysis was not performed and no conclusion were reached regarding efficacy or drug safety.

Results Point of Contact

• Title: Rebecca Avila
• Organization: ADMA Biologics, Inc.

reavila@admabio.com

561-989-5853

Study Officials

• Eliezer Katz, MD

  Clinical Trial and Consulting Services

  STUDY DIRECTOR

• Shailesh Chavan, MD

  Biotest Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2007
• First Posted: May 16, 2007
• Study Start: May 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 30, 2021
• Results First Posted: February 7, 2012

Record last verified: 2021-07

Locations

US (3)