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Also known as Pegylated Interferon Lambda (pegIFNλ), pegIFNλ, BMS-914143
Pegylated Interferon Lambda · 5 trials · 5 indications
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.
HCV = Hepatitis C virus; GT = Geno Type; RNA = Ribonucleic acid; LLOQ = Lower limit of quantitation
| 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 |
| 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 |
| Group 1: BMS-914143 (eGFR ≥ 80 mL/min/1.73 m2) | EXPERIMENTAL | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with normal renal function with eGFR ≥ 80 mL/min/1.73 m2 |
| Group 2: BMS-914143 (eGFR 60 to 79 mL/min/1.73 m2) | EXPERIMENTAL | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with mild renal dysfunction with eGFR 60 to 79 mL/min/1.73 m2 |
| Group 3: BMS-914143 (eGFR 30 to 59 mL/min/1.73 m2) | EXPERIMENTAL | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with moderate renal dysfunction with eGFR 30 to 59 mL/min/1.73 m2 |
| Group 4: BMS-914143 (eGFR 15 to 29 mL/min/1.73 m2) | EXPERIMENTAL | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with severe renal dysfunction with eGFR 15 to 29 mL/min/1.73 m2 |
| Group 5: BMS-914143 (eGFR < 15 mL/min/1.73 m2) | EXPERIMENTAL | BMS-914143 (Peginterferon Lambda-1a) single 180 µg Solution, Subcutaneous injection for subjects with end-stage renal dysfunction with eGFR \< 15 mL/min/1.73 m2 (on hemodialysis \[HD\] or non-HD) |
| Name | Type | Description |
|---|---|---|
| Pegylated-Interferon-lambda | BIOLOGICAL | - |
| Ribavirin | DRUG | - |
| Daclatasvir | DRUG | - |
| 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 |
| 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 |
| BMS-914143 (Peginterferon Lambda-1a) | BIOLOGICAL | - |
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 therapy studied for the treatment of Hepatitis C and Hepatitis C Virus infection. It was evaluated both as part of combination regimens with direct-acting antivirals and ribavirin, and in patients with chronic HCV who also had underlying hemophilia.
Pegylated Interferon Lambda is an exogenous protein designed to target F8. By engaging this target, it is intended to act within the interferon lambda pathway as an antiviral agent for Hepatitis C. It is a monoclonal antibody modality asset developed for infectious disease indications.
Pegylated Interferon Lambda is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company sponsored the clinical studies evaluating the agent in Hepatitis C and Hepatitis C Virus, including combination regimens with direct-acting antivirals and ribavirin.
Pegylated Interferon Lambda is in Phase 2 development and remains investigational. Its clinical program includes Phase 2 and Phase 3 studies, all of which are completed, with no active trials currently listed. It has not been established as an approved therapy.
Pegylated Interferon Lambda has been studied in completed trials including NCT01795911, NCT01741545, NCT01616524, and NCT01309932. These randomized, double-blind, active-controlled studies enrolled patients with Hepatitis C or Hepatitis C Virus across the United States and multiple other countries, with total enrollment of 951 participants.
Yes, Pegylated Interferon Lambda is also known as pegIFNλ, Pegylated-Interferon-lambda, and Pegylated interferon lambda (pegIFNλ). These names refer to the same Bristol-Myers Squibb investigational agent studied in Hepatitis C and Hepatitis C Virus clinical trials.