Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Peginterferon alfa-2a · 9 trials · 6 indications
HBeAg seroconversion was defined as loss of HBeAg and the presence of hepatitis B envelope antibody (anti-HBe). The percentage of participants with HBeAg seroconversion at 24 weeks after EOT/POP was reported. The 95 percent (%) confidence interval (CI) was calculated by the Pearson-Clopper method. Intent-to-Treat (ITT) Population: All randomized participants regardless of treatment received.
Hematologic response was considered to be achieved if participants met all of the following criteria: normalization of white blood cells count to less than (\<) 10\*10\^9 per liter (/L) with normal differentiation, normalization of platelet count at \<450\*10\^9/L, and disappearance of all signs and symptoms of the disease. This response had to be confirmed at least 4 weeks after the first measure and beyond that.
Time to loss of previous hematologic response was defined as the interval between the first day of treatment in the study and the first day of loss of previous hematologic response during elapsed time of study. Hematologic response was considered to be achieved if participants met all of the following criteria: normalization of white blood cells count to \<10\*10\^9/L with normal differentiation, normalization of platelet count at \<450\*10\^9/L, and disappearance of all signs and symptoms of the disease. This response had to be confirmed at least 4 weeks after the first measure and beyond that.
CyR was based on the prevalence of Philadelphia chromosome-positive (Ph+) bone marrow cells in metaphase determined from reverse transcriptase polymerase chain reaction (RT-PCR). Major cytogenetic response was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). CCyR was achieved when there was absence of detectable Ph+ bone marrow cells and PCyR was achieved when 1 to 34 percent (%) of bone marrow cells were Ph+.
Time to loss of previous CyR was defined as the interval between the first day of treatment in the study and the first day of loss of previous CyR. CyR is based on the prevalence of Ph+ bone marrow cells in metaphase. Major CyR was categorized as either CCyR or PCyR. CCyR was achieved when there was absence of detectable Ph+ bone marrow cells and PCyR was achieved when 1 to 34% of bone marrow cells were Ph+.
MR was assessed using breakpoint cluster region - Abelson (BCR-ABL) proto-oncogene transcript levels measured by RT-PCR from peripheral blood. Number of participants with BCR-ABL/ABL ratio less than or equal to 10 (%) was reported.
Time to loss of previous MR was defined as the interval between the first day of treatment in the study and the first day of loss of previous MR. MR was assessed using BCR-ABL transcript levels measured by RT-PCR from peripheral blood.
Qualitative HBsAg assay reads "non-detectable"
Normalized ALT was defined as ALT value above the upper limit of normal (ULN) at Baseline with a decrease in ALT value to at/below the ULN at 48 weeks after end of treatment (Week 96). Negative HDV RNA was defined as HDV RNA not detected by polymerase chain reaction (PCR). The number of participants with ALT normalization and negative HDV RNA at Week 96 was reported.
An acute virologic response was determined by change from baseline in viral antigen/antibody laboratory data.
| Arm | Type | Description |
|---|---|---|
| A Pegasys | EXPERIMENTAL | - |
| B Untreated Control | NO_INTERVENTION | - |
| C Fibrosis non-randomized | EXPERIMENTAL | - |
| Switch | EXPERIMENTAL | - |
| 1 | EXPERIMENTAL | - |
| 2 | EXPERIMENTAL | - |
| Peginterferon alfa-2a | EXPERIMENTAL | Participants will receive peginterferon alfa-2a subcutaneously in doses between 90 and 450 microgram (mcg) once weekly until medically indicated as judged by the treating investigator. |
| PEG 24 weeks | EXPERIMENTAL | peginterferon alpha 2a 180mcg for 24 weeks |
| PEG 48 weeks | EXPERIMENTAL | peginterferon alpha 2a 180mcg 48 weeks |
| Control | NO_INTERVENTION | No treatment for 72 weeks |
| Capecitabine + Peginterferon alfa-2a | EXPERIMENTAL | Treatment-naive participants with advanced liver cancer will receive combination treatment with capecitabine (1000 milligrams per meter-squared \[mg/m\^2\] twice daily orally on Days 1 to 14 of each 21-day cycle) and peginterferon alfa-2a (180 micrograms (mcg) subcutaneous \[SC\] every week during each 21-day cycle) until at least 6 cycles (18 weeks) or disease progression, intolerable toxicity, or consent withdrawal. |
| Group A: Monotherapy with Peginterferon alfa-2a | EXPERIMENTAL | Participants will receive peginterferon alfa-2a alone, administered over 48 weeks. |
| Group B: Combination with Peginterferon alfa-2a + Ribavirin | EXPERIMENTAL | Participants will receive combination therapy with peginterferon alfa-2a plus ribavirin, administered over 48 weeks. |
| Single Arm | EXPERIMENTAL | - |
| 3 | EXPERIMENTAL | - |
| 4 | NO_INTERVENTION | - |
| Name | Type | Description |
|---|---|---|
| peginterferon alfa-2a [Pegasys] | DRUG | Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48 |
| placebo | DRUG | orally daily, 96 weeks |
| tenofovir | DRUG | 245mg po daily, 96 weeks |
| Peginterferon alfa-2a | DRUG | Peginterferon alfa-2a in doses between 90 and 450 mcg will be administered subcutaneously once weekly until medically indicated as judged by the treating investigator. |
| Capecitabine | DRUG | Participants will receive oral capecitabine, 1000 mg/m\^2 twice daily on Days 1 to 14 of each 21-day cycle, for at least 6 cycles (18 weeks). Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal. |
| Ribavirin | DRUG | Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses. |
Inclusion Criteria: * Male or female patients, 3 years to \<18 years of age at baseline * Positive HBsAg for more than 6 months * Positive HBeAg and detectable HBV DNA at screening * A liver biopsy obtained within the past 2 years prior to baseline (and more than 6 months after the end of previous ...
Peginterferon Alfa-2A is used for chronic hepatitis B, chronic hepatitis C, chronic hepatitis D, chronic myelogenous leukemia, and hepatocellular carcinoma. It is being studied in clinical trials for these conditions, with completed trials focusing on chronic hepatitis B and chronic myelogenous leukemia.
Peginterferon Alfa-2A is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's efficacy in various chronic viral hepatitis and leukemia indications.
Peginterferon Alfa-2A is in Phase 2 clinical development. It has completed five trials, including Phase 1 and Phase 3 studies, but the current development stage is Phase 2. It remains investigational and is not yet approved for any indication.
Peginterferon Alfa-2A has completed five clinical trials, including NCT00962871 and NCT00962975 for chronic hepatitis B, NCT02736721 for chronic myelogenous leukemia, and NCT02992704 for inactive chronic hepatitis B carriers. All trials are completed with no active trials ongoing.
Yes, Peginterferon Alfa-2A is also known as Pegasys. Clinical trials reference Pegasys in their titles, such as NCT00962871 and NCT00962975, confirming that Peginterferon Alfa-2A and Pegasys refer to the same drug.