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21Cases

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

2021-09-01 - 2025-03-31

Phase I/II

Completed
  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Recruiting4Sites

Terminated1Sites

2018-10-30 - 2022-12-31

Phase III

Completed
  • Condition/Disease

  • Test Drug

Participate Sites
10Sites

Recruiting10Sites

2021-10-01 - 2027-11-01

Phase III

Active
  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Recruiting5Sites

2025-01-01 - 2029-12-12

Phase III

Active
  • Condition/Disease

  • Test Drug

Participate Sites
13Sites

Recruiting13Sites

2025-03-31 - 2028-01-31

Phase I

Active
  • Condition/Disease

  • Test Drug

Participate Sites
10Sites

Recruiting10Sites

2024-11-20 - 2034-12-31

Phase III

Active
  • Condition/Disease

  • Test Drug

Participate Sites
6Sites

Recruiting6Sites

2025-01-10 - 2031-05-31

Phase II

Active
  • Condition/Disease

  • Test Drug

Participate Sites
6Sites

Recruiting6Sites

2020-08-17 - 2023-12-12

Phase I/II

Completed
  • Condition/Disease

  • Test Drug

Participate Sites
6Sites

Recruiting6Sites

2020-01-06 - 2026-01-31

Phase III

Completed
  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Recruiting5Sites

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