Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pegylated interferon alfa-2b (PegIntron), Pegylated interferon alfa-2b (SCH 54031)
pegylated interferon alfa-2b · 5 trials · 6 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.
| 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) |
| 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 |
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 used for the treatment of Hepatitis C, Chronic Hepatitis B (CHB), and Melanoma. It is being developed by Merck & Company, Inc. (MRK) and is currently in Phase 2 clinical development for these indications.
Pegylated Interferon Alfa-2b is a pegylated form of interferon alfa-2b, which works by modulating the immune system to fight viral infections and certain cancers. It is not a monoclonal antibody, despite being listed under that modality, and its specific molecular target is not detailed.
Pegylated Interferon Alfa-2b is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in Hepatitis C, Chronic Hepatitis B, and Melanoma.
Pegylated Interferon Alfa-2b is in Phase 2 clinical development. It has completed one Phase 2 trial in Melanoma, as well as two Phase 3 trials in Hepatitis C and Chronic Hepatitis B. The drug is investigational and not yet approved for any indication.
Pegylated Interferon Alfa-2b has been studied in three completed trials: NCT00371761 in Chronic Hepatitis B, NCT00686517 in Hepatitis C, and NCT02155322 in Melanoma. The trials enrolled a total of 130 participants, with the Melanoma study being a Phase 2 trial.
Yes, Pegylated Interferon Alfa-2b is also known as PegIntron, as indicated by the trial title NCT00371761. This alternative name is used in clinical research and medical literature to refer to the same drug product.