A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP)

Part of paid clinical trials in Long Beach, California.

Sponsor
Amgen
Study ID
NCT07700238
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Primary Immune Thrombocytopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Romiplostim — DRUG
    Administered subcutaneously.
  • Predniso(lo)ne — DRUG
    Administered orally.

Study Details

This Phase 3 study is designed to evaluate the efficacy and safety of romiplostim in combination with predniso(lo)ne compared with predniso(lo)ne alone in adults with previously untreated Primary Immune Thrombocytopenia (ITP).

Key Dates

First listed
Jul 13, 2026
Start date
Aug 21, 2026
Status verified
Sep 2026
Primary completion
Sep 14, 2029
Completion
Oct 14, 2029

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Romiplostim + Predniso(lo)ne
    Participants will receive romiplostim administered subcutaneously (SC) in combination with predniso(lo)ne administered orally during Part 1 of the study. Participants who complete Part 1 of the study will enter Part 2 and continue participation for study assessments.
  • Active Comparator: Predniso(lo)ne
    Participants will receive predniso(lo)ne administered orally during Part 1 of the study. Participants who complete Part 1 of the study will enter Part 2 and continue participation for study assessments.

Primary Outcome Measure

Percentage of Participants With a Durable Platelet Response (DPR) [ Time Frame: 8 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
MemorialCare Long Beach Medical CenterLong BeachCalifornia90806-
The Bleeding and Clotting Disorders InstitutePeoriaIllinois61614-
Hematology Oncology Associates of FredericksburgFredericksburgVirginia22408-

Find similar trials in Long Beach, CA

By research site
MemorialCare Long Beach Medical Center· Long Beach, CAThe Bleeding and Clotting Disorders Institute· Peoria, ILHematology Oncology Associates of Fredericksburg· Fredericksburg, VA

Related Studies