Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Peginterferon alfa-2b · 4 trials · 6 indications
For virological response, a participant was defined as a responder if his/her serum sample tested negative for Hepatitis D Virus - ribonucleic acid (HDV-RNA) by polymerase chain reaction (PCR) at end of treatment (EOT).
A participant was defined as a responder if his alanine aminotransferase (ALT) level after 52 weeks, i.e. at EOT, was below the upper reference range as specified by Bioclinica. The normal reference range for ALT is 5-55 U/L.
The combined response was defined as an ALT level below the upper reference range and a negative HDV-RNA test. The normal reference range for ALT is 5-55 U/L.
Definitions: Fibrosis scoring: F0 (no fibrosis), F1 (stellate enlargement of portal tract without septa formation, F2 (enlargement of portal tract with rare septa formation, F3 (numerous septa without cirrhosis), F4 (cirrhosis). Improved: Participants whose METAVIR fibrosis score at up to Month-36 decreases by 1 or more units compared to baseline. No Change: Participants whose METAVIR fibrosis score at up to Month-36 is the same as the baseline score. Worsened: Participants whose METAVIR fibrosis score at up to Month-36 increases by 1 or more units compared to baseline.
Clinical events are liver decompensation \[variceal bleeding, development of Child-Pugh Class C, hepatic encephalopathy ≥Grade 2, ascites\], hepatic carcinoma, death, and/or liver transplantation
Participants were tested for focal lesions by liver ultrasound and for AFP levels every 6 months the during study (treatment and follow-up). The development of hepatocellular carcinoma was determined by: 1. the appearance of a focal lesion detected by liver ultrasound with metastases confirmed by fine needle biopsy, or 2. the appearance of a focal lesion detected by ultrasound + alphafetoprotein (AFP) levels in blood \>400 ng/mL.
| Arm | Type | Description |
|---|---|---|
| PegIntron | EXPERIMENTAL | All participants received PegIntron (Peginterferon alfa-2b) weekly based on their body weight. |
| PEG-Intron (peginterferon alfa-2b) 0.5 µg/kg Weekly (QW) | EXPERIMENTAL | PEG-Intron 0.5 µg/kg Weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up |
| Untreated Control | NO_INTERVENTION | - |
| Arm A - PegIntron | EXPERIMENTAL | Participants randomized to Arm A received peginterferon α-2b (PegIntron), 50 μg, weekly, subcutaneously (SC), for a period of 3 years. |
| Arm B - Control | OTHER | Participants randomized to Arm B were under observation and received no treatment. |
| Name | Type | Description |
|---|---|---|
| Peginterferon alfa-2b (PegIntron, SCH 54031) | BIOLOGICAL | Peginterferon alfa-2b 1.5 mcg/kg/wk subcutaneously (SC) for 52 weeks. |
| peginterferon alfa-2b (SCH 54031) | BIOLOGICAL | 0.5 µg/kg Weekly QW SC for 36 months |
| Peginterferon alfa-2b | BIOLOGICAL | Peginterferon alfa-2b, 50 μg, weekly, SC, for a period of 3 years. |
| Observation (no treatment) | OTHER | No treatment was given to participants enrolled in the control arm (Arm B). |
Inclusion Criteria: * Participants must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. * Age 18-65 years old. * HBsAg positive \>6 months. * ALT \>= 2 ULN \>6 months. * HDV RNA positive serology. * Serum antibody to he...
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.