Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pegylated interferon alfa-2b (PegIntron), Pegylated interferon alfa-2b (SCH 54031), PegIFN-2b, SCH 054031, MK-4031, Peginterferon alfa-2b, PEG-Intron™, Peginterferon alfa-2b (PegIFN-2b)
pegylated interferon alfa-2b · 7 trials · 9 indications
1. Serological response is defined as Loss of HBeAg (Hepatitis B e antigen) and Appearance of anti-HBe (Hepatitis B e antibodies); participant is HBeAg negative and anti-HBe positive. 2. Virological response was defined as having \< 10\^5 copies/mL of serum HBV DNA (Hepatitis B Virus Deoxyribonucleic Acid) by real-time PCR (Polymerase Chain Reaction). 3. Biochemical response was defined as acheiving normal levels of ALT (Alanine Aminotransferase) level in Units/L.
Number of participants with SVR at 24-week follow up after treatment with PEG-Intron and Ribavirin in post-orthotopic liver transplant recipients with recurrent HCV.
LLQ = 30 IU/mL by reverse transcription polymerase chain reaction (RT-PCR) (Taqman Roche)
SR was defined as serum Hepatitis C Virus (HCV RNA) level at the end of 6-month follow-up below 15 IU/mL.
An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
An adverse event was any unfavorable and unintended change in the structure, function, or chemistry of the body whether or not considered related to the study treatment.
SVR24 is defined as undetectable plasma hepatitis C virus ribonucleic acid (HCV-RNA) at 24 weeks after the end of all study treatment. If there was no value in the FW24 visit window, the closest value available chronologically after this window was used; if a value was still missing after that, the value from Follow-up Week 12 (FW12) was used. HCV-RNA is detected by a nucleic acid amplification test and the lower limit of detection for this assay is 9.3 IU/mL.
AUC0-∞ is a measure of the mean concentration levels of drug in the plasma after the dose.
AUC0-last is a measure of the total amount of drug in the plasma from the dose to the last measurable sample.
Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
Tmax is a measure of the time to reach the maximum concentration in the plasma after the drug dose.
T1/2 is the time required for a given drug concentration in the plasma to decrease by 50%.
CL/F is a calculation of the rate at which a drug is removed from the body via renal, hepatic and other clearance pathways, expressed as volume (milliliters) per unit of time (minutes).
Vd/F is defined as the distribution of a medication between the plasma and the rest of the body after the dose. It is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of the drug.
| Arm | Type | Description |
|---|---|---|
| PegIntron | EXPERIMENTAL | PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase |
| Adefovir | ACTIVE_COMPARATOR | Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase |
| PEG-Intron plus Rebetol (RBV) | EXPERIMENTAL | PEG-Intron plus RBV treatment for up to 48 weeks with 24-week follow up. SCH 54031 PEG-Intron 1.5 ug/kg SC per week plus SCH 18908 REBETOL twice daily (BID) PO with food, dosed as followed: Weeks 1 and 2, RBV Dose 400 mg (2 capsules, 1 AM and 1 PM). At the end of Weeks 2 and 4 of Treatment (tx), a complete blood count (CBC) was performed. An increase in RBV dose was permitted only if the hemoglobin was \>10 g/dL. At Weeks 3 and 4, RBV dose was 800 mg (4 capsules, 2 AM and 2 PM). From Weeks 5 to 48, RBV doses could be increased based on subject body weight. For subjects weighing \<65 kg, maximum dose of RBV was to be 800 mg (4 capsules, 2 AM and 2 PM), for subjects weighing 65-85 kg, max dose of RBV was 1000 mg/day (5 capsules, 2 AM and 3 PM), for subjects weighing \>85 kg, max dose of RBV was 1200 mg/day, 6 capsules, 3 AM and 3 PM). |
| Standard therapy | ACTIVE_COMPARATOR | Slow responders (defined as being polymerase chain reaction \[PCR\] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48. |
| Extended therapy | EXPERIMENTAL | Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72. |
| PEG-IFN 24 | EXPERIMENTAL | pegylated interferon alpha-2b 1.5 ug/kg/week for 24 weeks |
| PEG-IFN 12 | EXPERIMENTAL | pegylated interferon alpha-2b 1.5 ug/kg/week for 12 weeks |
| PEG-IFN + RVB 12 | EXPERIMENTAL | pegylated interferon alpha-2b 1.5 ug/kg/week in combination with ribavirin at the dose of 10.6 mg/kg/day for 12 weeks |
| PEG-IFN | EXPERIMENTAL | 6.0 μg/kg/week subcutaneous administration during the Induction Phase of 8 weeks followed by a dose of 3.0 μg/kg/week subcutaneous administration in the Maintenance Period (Week 8 to Month 12) |
| PegIFN-2b + RBV | PLACEBO_COMPARATOR | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA \<9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks. |
| PegIFN-2b + RBV + Boceprevir | ACTIVE_COMPARATOR | PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up. |
| Healthy Participants | ACTIVE_COMPARATOR | Participants with normal renal function defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
| Participants with Moderate Renal Impairment | EXPERIMENTAL | Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m\^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
| Participants with Severe Renal Impairment | EXPERIMENTAL | Participants with severe renal impairment defined as having a creatinine clearance test value of \<30 mL/min/1.73 m\^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg. |
| Name | Type | Description |
|---|---|---|
| Pegylated interferon alfa-2b (PegIntron) | BIOLOGICAL | Powder for injection in vials ( 100, and 120 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks |
| Adefovir dipivoxil (adefovir) | DRUG | 10 mg adefovir dipivoxil (equivalent to 5.4.5 mg adefovir) tablets, oral, dose of 1 tablet per day for up to 48 weeks |
| Combination of (a) pegylated interferon alfa-2b and (b) rebetol | DRUG | 1. Powder for injection in vials and Redipen (50, 80, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks 2. 200 mg capsules, oral, weight based dose of 400-1200 mg, daily for up to 48 weeks |
| Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®) | DRUG | 1. Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for 48 weeks 2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 48 weeks |
| Combination of pegylated interferon alfa-2b and ribavirin | DRUG | 1. Powder for injection in vial or Redipen (50, 80, 100, 120, and 150 microgram strength), subcutaneous, dose of 1.5 micrograms/kg, weekly for 72 weeks. 2. 200 mg capsules, oral, weight based dose of 800-1400 mg, daily for 72 weeks |
| Pegylated interferon alfa-2b | BIOLOGICAL | 1.5 ug/kg/week SC for 12 or 24 weeks |
| Ribavirin | DRUG | Ribavirin at the dose of 10.6 mg/kg/day for 12 weeks |
| PegIFN-2b | DRUG | PegIFN-2b (1.5 μg/kg/week subcutaneously) |
| RBV | DRUG | Ribavirin (600-1400 mg/day, orally, divided into two daily doses) |
| Placebo to Boceprevir | DRUG | Placebo to boceprevir (orally, three times per day) |
| Boceprevir | DRUG | Boceprevir (800 mg, orally, three times per day) |
| PegIFN-2b (Sylatron®) | DRUG | Single 4.5 μg/kg dose |
Inclusion Criteria: * Adult male or female, 18 to 70 years of age. * Documented positive serum hepatitis B surface antigen (HBsAg) for a minimum of 6 months prior to randomization. * Hepatitis B virus (HBV) replication and hepatitis documented by: * Serum HBV DNA (Hepatitis B Virus Deoxyribonucl...
Pegylated interferon alfa-2b is an investigational exogenous protein developed by Merck & Company, Inc. (MRK). It is being studied in Phase 3 clinical trials for chronic hepatitis B, hepatitis C, liver transplantation, and melanoma. The drug is also known as PegIntron and is often evaluated in combination with ribavirin (Rebetol).
Pegylated interferon alfa-2b is being developed for the treatment of chronic hepatitis B, hepatitis C, and as adjuvant therapy for melanoma. It is also studied in patients with recurrent hepatitis C after liver transplantation. These uses are investigational and have not been approved by regulatory authorities.
Pegylated interferon alfa-2b targets the F8 protein, which is classified as an exogenous protein target. By binding to F8, the drug exerts its therapeutic effects. This mechanism is under investigation in clinical trials for hepatitis and melanoma.
Pegylated interferon alfa-2b is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. Merck is responsible for the clinical development and potential commercialization of the drug.
Pegylated interferon alfa-2b is in Phase 3 clinical development. It has not been approved by the FDA for any indication. The drug is being evaluated in multiple completed Phase 3 trials, including studies in hepatitis C and chronic hepatitis B.
Pegylated interferon alfa-2b has been studied in several completed clinical trials, including NCT02155322 for melanoma, NCT00686517 for acute hepatitis C, NCT00378599 for recurrent hepatitis C after liver transplantation, and NCT00371761 for chronic hepatitis B. These trials are all completed.
Yes, pegylated interferon alfa-2b is also known as PegIntron. It is frequently studied in combination with ribavirin, which is marketed as Rebetol. Other names include SCH 54031. The drug is developed by Merck & Company, Inc. (MRK).