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Civacir 10% · 1 trial · 5 indications
The primary objective is to assess the effect of administering Civacir® anti-HCV immunoglobulin therapy on prevention of orthotopic liver transplant (OLT) HCV recurrence, as measured by the proportion of subjects with unquantifiable HCV RNA levels at 22 weeks post-OLT, compared to the control group (not treated with Civacir® and considered standard of care).
| Arm | Type | Description |
|---|---|---|
| Observational Control | NO_INTERVENTION | 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. |
| Civacir® 10% at 200 mg/kg dose | EXPERIMENTAL | 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. |
| Civacir® 10% at 300 mg/kg dose | EXPERIMENTAL | Subjects who attain HCV RNA \<100 IU/ml and are randomized to the Civacir® 300 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. |
| Name | Type | Description |
|---|---|---|
| Civacir® 10% | BIOLOGICAL | The active ingredient is Human Immunoglobulin G (IgG) which is a normal constituent purified from human source plasma containing a diversity of antibodies targeting the Hepatitis C Virus. |
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 treatm...
Civacir 10% is an investigational monoclonal antibody being studied for the prevention of hepatitis C virus (HCV) recurrence in liver transplant patients. It is intended for use in patients with hepatitis C infection, including those with hepatocellular carcinoma, viral hepatitis, and liver cirrhosis.
Civacir 10% is being developed by ADMA Biologics Inc, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ADMA. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy.
Civacir 10% is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. A Phase 3 clinical trial has been completed to evaluate its use in preventing hepatitis C virus recurrence in liver transplant patients.
Civacir 10% has been studied in one completed Phase 3 clinical trial, registered as NCT01804829. This trial, titled 'Civacir® Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients,' enrolled 80 participants in the United States.
Civacir 10% is a polyclonal immune globulin (IgG) product. It contains antibodies that target hepatitis C virus, potentially neutralizing the virus and preventing infection or recurrence in patients undergoing liver transplantation. The exact mechanism of action is being evaluated in clinical trials.
Civacir 10% is classified as a monoclonal antibody modality, but it is specifically a polyclonal immune globulin (IgG) product. It is derived from human plasma and contains a broad range of antibodies against hepatitis C virus, rather than a single monoclonal antibody.