Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liv… (NCT00473824) | Clinical Trial Compass
TerminatedPhase 2
Randomized Phase II Study of Hepatitis C Immune Globulin Intravenous (Human), Civacir(TM), in Liver Transplantation
Stopped: New sponsor's decision to pursue a redesigned clinical study
United States7 participantsStarted 2007-05
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 …
What they're measuring
1
Post Transplant Reduction in Viral Load (as Measured Quantitatively by Hepatitis C Virus (HCV) Reverse Transcription-Polymerase Chain Reaction (HCV RT-PCR)).
Timeframe: Outcome evaluations at 1 month (Day 28) and 6 months ( 24 weeks) post-tranplant.