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Also known as Civacir® 10%
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 polyclonal immune globulin (IgG) product developed by ADMA Biologics Inc. It is being studied to prevent hepatitis C virus (HCV) recurrence in liver transplant patients. It is a monoclonal antibody product in Phase 3 development for hepatitis C infection.
Civacir 10% is being studied to prevent hepatitis C virus (HCV) recurrence in patients who have undergone liver transplantation. The Phase 3 trial enrolled patients with hepatitis C infection, including those with hepatocellular carcinoma, viral hepatitis, and liver cirrhosis, all of whom were liver transplant candidates or recipients.
Civacir 10% is developed by ADMA Biologics Inc, which trades on the Nasdaq under the ticker ADMA. The company is the sponsor of the clinical program evaluating the product in liver transplant patients at risk of hepatitis C recurrence.
Civacir 10% is in Phase 3 clinical development. It is investigational and has not been approved by the FDA. The Phase 3 trial evaluating the product has been completed.
Civacir 10% has been evaluated in one completed Phase 3 trial, NCT01804829, titled "Civacir Polyclonal Immune Globulin (IgG) to Prevent Hepatitis C Virus (HCV) Recurrence in Liver Transplant Patients." The trial enrolled 80 participants in the United States and used a no-treatment controlled, randomized design.
Yes, Civacir 10% is also written as Civacir 10%, with the registered trademark symbol. Both names refer to the same polyclonal immune globulin (IgG) product developed by ADMA Biologics Inc for preventing hepatitis C virus recurrence in liver transplant patients.