Ropeginterferon alfa-2b

Generic Name
Ropeginterferon alfa-2b
Brand Names
Besremi
Drug Type
Biotech
Chemical Formula
-
CAS Number
1335098-50-4
Unique Ingredient Identifier
981TME683S
Background

Polycythemia vera (PV) is the most common Philadelphia chromosome-negative myeloproliferative neoplasm (MPN), characterized by increased hematocrit and platelet/leukocyte counts, an increased risk for hemorrhage and thromboembolic events, and a long-term propensity for myelofibrosis and leukemia. Interferon alfa-2b has been used for decades to treat PV but r...

Indication

Ropeginterferon alfa-2b is indicated for the treatment of adult patients with polycythemia vera.

Associated Conditions
Polycythemia Vera (PV)
Associated Therapies
-

Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)

Recruiting
Conditions
First Posted Date
2024-07-17
Last Posted Date
2024-12-03
Lead Sponsor
FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
Target Recruit Count
319
Registration Number
NCT06506084
Locations
🇮🇹

Divisione Ematologia, Fondazione IRCCS Policlinico San Matteo, Pavia, Lombardia, Italy

🇮🇹

A.S.O. SS. Antonio e Biagio e C.Arrigo di Alessandria, Alessandria, Italy

🇮🇹

UOC Ematologia, ASST Papa Giovanni XXIII, Bergamo, Lombardia, Italy

and more 29 locations

P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk

First Posted Date
2024-06-21
Last Posted Date
2024-10-02
Lead Sponsor
PharmaEssentia
Target Recruit Count
150
Registration Number
NCT06468033

Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera

First Posted Date
2024-03-04
Last Posted Date
2024-11-06
Lead Sponsor
PharmaEssentia
Target Recruit Count
70
Registration Number
NCT06290765

Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities

Phase 2
Not yet recruiting
Conditions
Interventions
First Posted Date
2023-04-11
Last Posted Date
2023-04-11
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
60
Registration Number
NCT05808322
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy

First Posted Date
2022-08-10
Last Posted Date
2022-12-27
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
90
Registration Number
NCT05494528
Locations
🇨🇳

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, Taiwan

🇨🇳

China Medical University Hospital, Taichung, Taiwan

🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

and more 2 locations

A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU

Phase 2
Active, not recruiting
Conditions
Interventions
First Posted Date
2022-08-03
Last Posted Date
2024-04-03
Lead Sponsor
PharmaEssentia
Target Recruit Count
49
Registration Number
NCT05485948
Locations
🇨🇳

Xiangya Hospital Central South University, Changsha, China

🇨🇳

Peking Union Medical College Hospital, Beijing, China

🇨🇳

Nanfang Hospital affiliated to Southern Medical University, Guangzhou, China

and more 11 locations

A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection

First Posted Date
2022-07-20
Last Posted Date
2022-12-29
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
30
Registration Number
NCT05467553
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

🇨🇳

Taipei Medical University Hospital, Taipei, Taiwan

Ropeginterferon Alfa 2b for Early Myelofibrosis

First Posted Date
2021-08-04
Last Posted Date
2022-10-06
Lead Sponsor
The University of Hong Kong
Target Recruit Count
50
Registration Number
NCT04988815
Locations
🇭🇰

Department of Medicine, the University of Hong Kong, Queen Mary Hospital, Hong Kong, Hong Kong

Safety, Tolerability, Pharmacokinetics & Pharmacodynamics Study of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects

Phase 1
Completed
Conditions
Interventions
First Posted Date
2018-06-06
Last Posted Date
2019-11-26
Lead Sponsor
PharmaEssentia Japan K.K.
Target Recruit Count
36
Registration Number
NCT03546465
Locations
🇦🇺

Nucleus Network Limited, Melbourne, Victoria, Australia

P1101 in Treating Patients With Myelofibrosis

First Posted Date
2015-02-24
Last Posted Date
2023-08-30
Lead Sponsor
Mayo Clinic
Target Recruit Count
11
Registration Number
NCT02370329
Locations
🇺🇸

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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