Clinical Trials Logo

Clinical Trial Summary

A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia


Clinical Trial Description

PharmaEssentia is developing a pegylated (PEG) IFN-α product, P1101, for the treatment of Essential Thrombocythemia (ET) as lack of disease modifying therapies in essential ET constitutes a serious issue in modern hematology. Ropeginterferon alfa-2b-njft (P1101) may represent an effective, well-tolerated treatment with the ability to provide a deeper response and superior control of important blood parameters with the potential to alter the course of the disease and prevent progression to post-ET myelofibrosis (MF) and/or secondary acute myeloid leukemia (sAML). Ropeginterferon alfa-2b-njft (P1101) is currently being evaluated in comparison to ANA in the ongoing global Phase 3 clinical study, SURPASS ET. Enrolled patients will receive P1101 over 13 months followed by an extension period. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05482971
Study type Interventional
Source PharmaEssentia
Contact Jewell Jessup, PhD
Phone 1-800-999-2449
Email clinicaltrials@pharmaessentia.com
Status Recruiting
Phase Phase 2
Start date September 29, 2022
Completion date December 31, 2026

See also
  Status Clinical Trial Phase
Completed NCT04254978 - Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003) Phase 2
Active, not recruiting NCT03289910 - Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia Phase 2
Recruiting NCT02897297 - Myeloproliferative Neoplastic Diseases Observatory From Brest
Completed NCT00666549 - Research Tissue Bank
Completed NCT00052520 - Biological Therapy in Treating Patients With Advanced Myelodysplastic Syndrome, Acute or Chronic Myeloid Leukemia, or Acute Lymphoblastic Leukemia Who Are Undergoing Stem Cell Transplantation Phase 1/Phase 2
Completed NCT01192347 - French Observational Xagrid (FOX) Study In Adult Patients With Essential Thrombocythemia
Completed NCT01588015 - Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant Phase 1
Recruiting NCT04942080 - Interest of CALR Allele Burden in Diagnosis and Follow-up of Patients With CALR Mutated Myeloproliferative Syndromes (CALRSUIVI) N/A
Recruiting NCT05031897 - Reduced-Intensity Conditioning for the Prevention of Treatment-Related Mortality in Patients Who Undergo a Hematopoietic Stem Cell Transplant Phase 2
Recruiting NCT04262141 - IMG-7289 in Patients With Essential Thrombocythemia (ET) or Polycythemia Vera (PV) Phase 2
Completed NCT03907436 - The NUTRIENT Trial (NUTRitional Intervention Among myEloproliferative Neoplasms): Feasibility Phase N/A
Active, not recruiting NCT00588991 - Veliparib and Topotecan With or Without Carboplatin in Treating Patients With Relapsed or Refractory Acute Leukemia, High-Risk Myelodysplasia, or Aggressive Myeloproliferative Disorders Phase 1
Completed NCT00112593 - Fludarabine and Total-Body Irradiation Followed By Donor Stem Cell Transplant and Cyclosporine and Mycophenolate Mofetil in Treating HIV-Positive Patients With or Without Cancer N/A
Completed NCT01787552 - A Phase Ib/II Dose-finding Study to Assess the Safety and Efficacy of LDE225 + INC424 in Patients With MF Phase 1/Phase 2
Recruiting NCT03116542 - 18F-FLT (PET/CT) in Prefibrotic/Early Primary Myelofibrosis and Essential Thrombocythemia N/A
Recruiting NCT05882773 - Asian Myeloproliferative Neoplasm (MPN) Registry
Completed NCT02129101 - Azacitidine and Sonidegib or Decitabine in Treating Patients With Myeloid Malignancies Phase 1
Completed NCT00357305 - Vorinostat, Cytarabine, and Etoposide in Treating Patients With Relapsed and/or Refractory Acute Leukemia or Myelodysplastic Syndromes or Myeloproliferative Disorders Phase 1
Terminated NCT03972943 - CPAP in Treating Obstructive Sleep Apnea in Patients With Polycythemia Vera or Essential Thrombocythemia Early Phase 1
Completed NCT03745378 - Secondary Cancers in Myeloproliferative Neoplasms (MPN-K Study)