Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pegylated interferon alfa-2b · 3 trials · 3 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.
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-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 |
| 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 melanoma, chronic hepatitis B (CHB), and hepatitis C. 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 developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's efficacy in treating melanoma, chronic hepatitis B, and hepatitis C.
Pegylated Interferon Alfa-2b is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to assess its safety and efficacy for the treatment of melanoma, chronic hepatitis B, and hepatitis C.
Pegylated Interferon Alfa-2b has been studied in clinical trials including NCT00371761 for chronic hepatitis B, NCT00686517 for hepatitis C, and NCT02155322 for melanoma. These trials have been completed, with a total enrollment of 130 participants across all studies.
Yes, Pegylated Interferon Alfa-2b is also known as PegIntron. Clinical trials such as NCT00371761 refer to the drug as PegIntron, confirming that these names are used interchangeably for the same medication.