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9Cases

2025-03-01 - 2029-03-01

Phase III

Active
A randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial evaluating the efficacy and safety of Ropeginterferon alfa-2b (P1101) in adult patients with pre-fibrotic/early primary myelofibrosis or marked primary myelofibrosis classified as low- or intermediate-risk 1 according to DIPSS Plus (HOPE-PMF): core trial and its extension trial.
  • Condition/Disease

    Clinically relevant complete hematologic response (CrCHR) at week 80, and symptom assessment indicators at week 80. CrCHR was defined as: 1. Platelet count ≤ 400 x 10^9/L, and 2. White blood cell (WBC) ≤ 10 x 10^9/L, and 3. Peripheral blood: Heme (Hgb) ≥ 10.0 g/dL, and 4. No major thrombotic events, and 5. No progression to secondary acute myeloid leukemia (AML). Symptom assessment indicators were defined as: 6. No worsening of clinical symptoms according to the MFSAF Total Symptom Score (TSS) version 4.0; no worsening of clinical symptoms was defined as: - If the baseline TSS score ≤ 10, then the TSS score remained ≤ 10; or - If the baseline TSS score > 10, then the TSS score did not increase by > 50%.

  • Test Drug

    Ropeginterferon alfa-2b (P1101)

Participate Sites
14Sites

Recruiting14Sites

2023-08-01 - 2032-06-30

Phase III

Active
  • Condition/Disease

  • Test Drug

Participate Sites
7Sites

Recruiting7Sites

2024-06-03 - 2031-12-31

Phase III

Active
  • Condition/Disease

  • Test Drug

Participate Sites
4Sites

Recruiting4Sites

2023-11-01 - 2031-12-31

Phase III

Active
  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Recruiting5Sites

2023-07-31 - 2029-02-28

Phase III

Active
  • Condition/Disease

  • Test Drug

Participate Sites
12Sites

Recruiting12Sites

2023-07-01 - 2031-11-06

Phase III

Active
  • Condition/Disease

  • Test Drug

Participate Sites
12Sites

Recruiting12Sites

2023-06-01 - 2028-11-27

Phase III

Active
  • Condition/Disease

  • Test Drug

Participate Sites
9Sites

Recruiting9Sites

2022-09-01 - 2026-12-31

Phase III

Active
  • Condition/Disease

  • Test Drug

Participate Sites
7Sites

Recruiting7Sites

2024-03-01 - 2030-07-16

Phase III

Active
  • Condition/Disease

  • Test Drug

Participate Sites
10Sites

Recruiting10Sites