Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

About this trial

To evaluate whether orelabrutinib combined with romiplostim N01 can improve the quality of remission, increase the probability of successful drug withdrawal, and prolong the time to treatment failure in patients with primary immune thrombocytopenia (ITP) who have received at least one line of prior therapy.

Eligibility criteria

Qualifiers

Subjects voluntarily participate in this study and provide written informed consent;

Age 18-80 years, inclusive, regardless of gender;

ECOG score 0 to 2;

Documented diagnosis of chronic primary Immune Thrombocytopenia (ITP) with a disease duration >12 months;

Disqualifiers

Subjects suffer from severe ITP at screening;

Subjects have other diseases which mention in protocol;

Subjects develop intracranial hemorrhage within 6 months prior to screening;

Active and uncontrollable infection;

Trial design

Treatments tested in this trial

  • Orelabrutinib
  • Romiplostim N01

Treatment groups

28 Participants
are divided into 1 treatment group