Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PEG Interferon Alfa-2b · 1 trial · 1 indication
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
An adverse event (AE) is any untoward medical occurrence in a study participant administered a pharmaceutical product that does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product.
| Arm | Type | Description |
|---|---|---|
| PEG Interferon Alfa-2b 0.75 mcg/kg Once Weekly (OW) | EXPERIMENTAL | Participants receive PEG interferon alfa-2b 0.75 mcg/kg by subcutaneous (SC) injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. |
| PEG Interferon Alfa-2b 1.5 mcg/kg OW | EXPERIMENTAL | Participants receive PEG interferon alfa-2b 1.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. |
| PEG Interferon Alfa-2b 3 mcg/kg OW | EXPERIMENTAL | Participants receive PEG interferon alfa-2b 3 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. |
| PEG Interferon Alfa-2b 4.5 mcg/kg OW | EXPERIMENTAL | Participants receive PEG interferon alfa-2b 4.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. |
| PEG Interferon Alfa-2b 6 mcg/kg OW | EXPERIMENTAL | Participants receive PEG interferon alfa-2b 6 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. |
| PEG Interferon Alfa-2b 7.5 mcg/kg OW | EXPERIMENTAL | Participants receive PEG interferon alfa-2b 7.5 mcg/kg by SC injection OW for up to 40 weeks. They also receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and 500 to 1000 mg afterwards every 4 to 6 hours as needed. Total daily dose of acetaminophen should not exceed 3000 mg. |
| Name | Type | Description |
|---|---|---|
| PEG Interferon Alfa-2b | DRUG | Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment. |
| Acetaminophen | DRUG | Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg. |
Inclusion Criteria: * Had a response of stable disease or better in PEG interferon alfa-2b base study C/I97-188 (MK-4031-006). * Has a Performance Status of 0 (normal activity), 1 (symptoms, but fully ambulatory), or 2 (symptomatic, but in bed \<50% of the day). * Is enrolled within two weeks of co...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 5 | PHASE3 | ACE-536 |
| AbbVie, Inc. | ABBV | 4 | PHASE3 | Navitoclax, Ruxolitinib |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE3 | Pelabresib, Ruxolitinib |
| Karyopharm Therapeutics, Inc. | KPTI | 4 | PHASE3 | Selinexor, Ruxolitinib |
| Geron Corporation | GERN | 2 | PHASE3 | Imetelstat |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Bomedemstat |
| Incyte Corporation | INCY | 10 | PHASE2 | Ruxolitinib |
| GSK plc Sponsored ADR | GSK | 2 | PHASE2 | MMB |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Elritercept, Ruxolitinib |
| Eli Lilly and Company | LLY | 1 | PHASE1 | LY3410738, Venetoclax, Azacitidine |
| Disc Medicine, Inc. | IRON | 1 | PHASE1 | DISC-0974 |
| Galecto, Inc. | GLTO | 1 | PHASE2 | GB2064 |
| Prelude Therapeutics, Inc. | PRLD | 1 | PHASE1 | PRT12396 |
| United Therapeutics Corporation | UTHR | 1 | PHASE2 | bomedemstat |
PEG Interferon Alfa-2b is being studied for use in neoplasms, chronic hepatitis C, chronic hepatitis D, hepatocellular carcinoma, and chronic hepatitis C with liver fibrosis. It is an investigational therapy in clinical development and has not been approved for these uses.
PEG Interferon Alfa-2b is developed by Merck & Company, Inc., which is listed on the stock exchange under the ticker MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in various conditions.
PEG Interferon Alfa-2b is in Phase 1 clinical development. While some completed trials were Phase 3, the current development stage is Phase 1, and the drug remains investigational and not approved by regulatory authorities.
PEG Interferon Alfa-2b has been studied in several completed trials, including NCT00049842 for chronic hepatitis C with liver fibrosis, NCT00686790 for hepatitis B and D co-infection, NCT00759109 for hepatocellular carcinoma, and NCT03554005 for solid tumors.
Yes, PEG Interferon Alfa-2b is also referred to as Peginterferon Alfa-2b. Clinical trial titles use both names interchangeably, such as in NCT00686790, which mentions Peginterferon Alfa-2b, and NCT03554005, which uses PEG Interferon Alfa-2b.