Drugs / PegIFN-alpha-2a
PegIFN-alpha-2a
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT02742324 | Mar 2016 → Dec 2021 | myelofibrosis | French Innovative Leukemia Organisation | Completed | No outcome recorded |
| Phase 23 trials · 1 missed | ||||||
| Phase 2 | NCT05005507 | Nov → Dec 2021 | chronic hepatitis B virus infection | Janssen Research & Development, LLC | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT04667104 | Feb 2021 → May 2022 | chronic hepatitis B virus infection | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04439539 | Sep 2020 → Aug 2023 | chronic hepatitis B virus infection | Janssen Research & Development, LLC | Completed | Missed primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT00887081 | Jan 2009 → Dec 2013 | hemoglobinopathy | Azienda Ospedaliera V. Cervello | Unknown | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT04585789 Background | Mar 2021 → Feb 2023 | chronic hepatitis B virus infection | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01290731 Background | Jan 2011 → Aug 2012 | chronic hepatitis C virus infection | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2014-04-12 | Janssen Research & Development, LLC | Results Final Data from the Phase 2 COSMOS Study of Janssen's Once-Daily Simeprevir in Combination with Sofosbuvir Presented at The International Liver Congress™ 2014 of the European Association for the Study of the Liver (EASL) jnj.com ↗
In patients with the IL28B CT and TT genotypes, 66 percent and 60 percent achieved SVR12, respectively. |
| 2013-05-21 | Janssen Research & Development, LLC | Results Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients jnj.com ↗
In the simeprevir arm, on-treatment failure rates were 3 percent and relapse rates were 19 percent, compared to 27 percent and 48 percent in the placebo arm. |
| 2013-04-23 | Janssen Research & Development, LLC | Results Findings from Two Phase 3 Studies of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Patients jnj.com ↗
In both studies, 50 percent of patients receiving pegylated interferon and ribavirin alone achieved SVR12. |
| 2011-03-07 | Bristol-Myers Squibb | Results New Data on Multiple Bristol-Myers Squibb Investigational Hepatitis C Compounds to be Presented at The International Liver Congress 2011 bms.com ↗
Pegylated Interferon-Lambda (PEGIFN-λ) shows superior viral response with improved safety and tolerability versus PEGIFNα-2A in HCV patients (G1/2/3/4): EMERGE Phase IIb through week 12 |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2014-04-12 | Janssen Research & Development, LLC | Final Data from the Phase 2 COSMOS Study of Janssen's Once-Daily Simeprevir in Combination with Sofosbuvir Presented at The International Liver Congress™ 2014 of the European Association for the Study of the Liver (EASL) jnj.com ↗ |
| 2013-05-21 | Janssen Research & Development, LLC | Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients jnj.com ↗ |
| 2013-04-23 | Janssen Research & Development, LLC | Findings from Two Phase 3 Studies of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Patients jnj.com ↗ |
| 2011-03-07 | Bristol-Myers Squibb | New Data on Multiple Bristol-Myers Squibb Investigational Hepatitis C Compounds to be Presented at The International Liver Congress 2011 bms.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | PegIFN-alpha2a | “Peg-IFN-alpha-2a is administered subcutaneously once a week.” NCT02742324 ↗ |
| Known as | PegIFNα-2a | “evaluated this regimen plus pegylated interferon alpha-2a (PegIFN-α2a) in patients with virologically suppressed CHB.” PMID 40919077 ↗ Jul 20251“standard of care (SoC), PegIFNα-2a (P) and ribavirin (R)” NCT01290731 ↗ |
| Known as | Pegylated interferon | “Pegylated interferon (pegIFN alpha-2a)” NCT01290731 ↗ |
| Known as | pegylated interferon alpha-2a | “evaluated this regimen plus pegylated interferon alpha-2a (PegIFN-α2a) in patients with virologically suppressed CHB.” PMID 40919077 ↗ Jul 2025 |
| Modality | Protein / enzyme biologic | “combination therapy with pegylated interferon and ribavirin” NCT00887081 ↗ |
| Route | Subcutaneous | “180 mcg injected subcutaneously (by a syringe under the skin) once weekly” NCT01290731 ↗ |