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GI-5005 · 2 trials · 2 indications
Early Virologic Response (EVR) is a response measured by the reduction of virus in the blood after 12 weeks of treatment.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | GI-5005 monotherapy continuing on to triple therapy |
| 2 | ACTIVE_COMPARATOR | Standard of care alone |
| Name | Type | Description |
|---|---|---|
| GI-5005 | DRUG | 40YU, subcutaneous |
| Pegylated Interferon and Ribavirin | DRUG | Pegylated interefron is an injection and ribavirin is an oral tablet |
Inclusion Criteria: * Chronic hepatitis C infection with genotype 1 based on serum positivity for HCV RNA or a positive test for serum anti-HCV antibody for at least 6 months; * One of the following response criteria based on response to prior combination therapy with pegylated or non-pegylated int...
GI-5005 is an investigational small molecule developed by ImmunityBio, Inc. for the treatment of chronic hepatitis C. It was studied as a therapeutic agent for genotype 1 chronic hepatitis C infection, including use alongside standard of care therapy. It is not an approved product and remains in clinical development.
GI-5005 was studied for the treatment of chronic hepatitis C, with the Phase 2 program focused specifically on genotype 1 chronic hepatitis C infection. Trials evaluated it both as a stand-alone treatment and in combination with pegylated interferon plus ribavirin standard of care therapy.
GI-5005 is developed by ImmunityBio, Inc., which trades on the Nasdaq under the ticker IBRX. The company sponsored the clinical trials evaluating the agent in chronic hepatitis C, including the Phase 2 study of GI-5005 combined with pegylated interferon plus ribavirin.
GI-5005 is in Phase 2 development. Its Phase 2 trial has completed, and a Phase 1 trial has also completed. The program has not advanced beyond Phase 2, and GI-5005 is an investigational agent rather than an approved therapy for chronic hepatitis C.
GI-5005 has been evaluated in two completed trials. NCT00606086 was a Phase 2 study of GI-5005 combined with pegylated interferon plus ribavirin versus standard of care alone in 140 patients with genotype 1 chronic hepatitis C. NCT00124215 was a Phase 1 study in 48 patients with chronic hepatitis C.
The GI-5005 clinical program enrolled 188 patients across its two completed trials. The Phase 2 trial NCT00606086 enrolled 140 patients with genotype 1 chronic hepatitis C, and the Phase 1 trial NCT00124215 enrolled 48 patients with chronic hepatitis C. Both studies were conducted in the United States.