Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pegylated-Interferon-lambda · 1 trial · 1 indication
SVR12 was defined as HCV ribonucleic acid (RNA) less than the lower limit of quantitation, target detected or target not detected at follow-up Week 12.
| Arm | Type | Description |
|---|---|---|
| Cohort A: Genotype-2,-3 (Lambda/RBV/DCV) | EXPERIMENTAL | Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 12 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 12 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks |
| Cohort B: Genotype-1b,-4 (Lambda/RBV/DCV) | EXPERIMENTAL | Lambda 180 μg solution for subcutaneous (SC) injection, once weekly for 24 weeks Ribavirin (RBV) 200 mg tablet by mouth (oral), twice daily for 24 weeks Daclatasvir (DCV) 60mg tablet by mouth (oral), once daily for 12 weeks |
| Name | Type | Description |
|---|---|---|
| Pegylated-Interferon-lambda | BIOLOGICAL | - |
| Ribavirin | DRUG | - |
| Daclatasvir | DRUG | - |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * Severe hemophilia (defined as \< 1% factor activity level) * Infection with the hepatitis C virus (HCV) with underlying hemophilia * Males 18 years of age and above * Have n...
Pegylated Interferon Lambda is an investigational drug being studied for the treatment of Hepatitis C Virus (HCV) infection, including chronic HCV. It is a pegylated form of interferon lambda, which is being evaluated in clinical trials for its safety and efficacy in patients with different genotypes of hepatitis C.
Pegylated Interferon Lambda is being developed by Bristol-Myers Squibb Company, which trades under the ticker symbol BMY on the stock exchange. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Hepatitis C Virus infection.
Pegylated Interferon Lambda is in Phase 2 and Phase 3 clinical trials for Hepatitis C Virus. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical development to assess its safety and efficacy.
Pegylated Interferon Lambda has been studied in several clinical trials, including NCT01309932, a Phase 2 safety study with 165 participants, and NCT01616524, a Phase 3 efficacy study with 880 participants. Other trials include NCT01741545 and NCT01795911, all completed, focusing on hepatitis C treatment.
Pegylated Interferon Lambda is a monoclonal antibody that works by targeting the immune system's response to Hepatitis C Virus. It is designed to stimulate the body's natural antiviral defenses, helping to clear the infection. The pegylation process extends the drug's activity in the body.
Pegylated Interferon Lambda is a distinct investigational drug being developed for hepatitis C. It is not the same as pegylated interferon alfa, which is used as a comparator in some trials. Its unique mechanism and pegylation differentiate it from other interferons in development.