Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pegylated interferon lambda · 3 trials · 2 indications
HCV = Hepatitis C virus; GT = Geno Type; RNA = Ribonucleic acid; LLOQ = Lower limit of quantitation
| Arm | Type | Description |
|---|---|---|
| Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir | EXPERIMENTAL | - |
| Arm 2: pegIFNλ + Ribavirin + Daclatasvir | EXPERIMENTAL | - |
| Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir | EXPERIMENTAL | - |
| Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir | EXPERIMENTAL | Pegylated Interferon Lambda 180 μg Solution, Subcutaneous Once weekly for 12 weeks; Ribasphere 1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg oral tablets per day \[subjects should take either 400 mg for subjects \< 75 kg or 600 mg ≥ 75 kg in the morning with food and 600 mg in the evening with food\] for 12 weeks; Daclatasvir 60 mg oral tablet Once daily for 12 weeks |
| A1: pegIFNλ+BMS-790052+Placebo for BMS-650032+Ribavirin | EXPERIMENTAL | Part A |
| A2: pegIFNλ+BMS-650032+Placebo for BMS-790052+Ribavirin | EXPERIMENTAL | Part A |
| A3: pegIFNα-2a+PBO for BMS-790052+PBO for BMS-650032+RBV | ACTIVE_COMPARATOR | Part A |
| A4: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (24 weeks) | EXPERIMENTAL | Part B |
| A5: pegIFNλ+BMS-790052+BMS-650032+Ribavirin (16 weeks) | EXPERIMENTAL | Part B |
| A6: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (24 weeks) | EXPERIMENTAL | Part B |
| A7: pegIFNλ+BMS-790052+BMS-650032+Placebo for RBV (16 weeks) | EXPERIMENTAL | Part B |
| Name | Type | Description |
|---|---|---|
| Pegylated interferon lambda (pegIFNλ) | BIOLOGICAL | Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks |
| Pegylated interferon alfa-2a (pegIFNα-2a) | BIOLOGICAL | Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks |
| Ribavirin | DRUG | Tablets, Oral, 400 mg, Twice daily, 24 weeks |
| Daclatasvir | DRUG | Tablets, Oral, 60 mg, Once daily, 12 weeks |
| Placebo matching Daclatasvir | DRUG | Tablets, Oral, 0 mg, Once daily, 12 weeks |
| Pegylated Interferon Lambda | BIOLOGICAL | - |
| Ribasphere | DRUG | - |
| BMS-790052 (NS5A Inhibitor) | DRUG | Tablets, Oral, 60 mg, Once daily, 24 weeks |
| Ribavirin (RBV) | DRUG | Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks |
| BMS-650032 (NS3 Protease Inhibitor) | DRUG | Tablets, Oral, 200 mg, Twice daily, 24 weeks |
| Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor) | DRUG | Tablets, Oral, 0 mg, Twice daily, 24 weeks |
| Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor) | DRUG | Tablets, Oral, 0 mg, Once daily, 24 weeks |
| Placebo for Ribavirin (RBV) | DRUG | Tablets, Oral, 0 mg, Twice daily, 24 weeks |
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Chronic hepatitis C, Genotype 2 or 3 * Naïve to prior anti-HCV therapy Exclusion Criteria: * Infected with HCV other than Genotype 2 or 3 * Positive Hepatitis B surface ant...
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.