ATRA for Management of Primary ITP
ConditionImmune Thrombocytopenia
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital
About this trial
A multicenter, randomized, double-blind placebo-controlled study to report the efficacy and safety of all-trans etinoic acid compared to placebo for the treatment of adults with corticosteriod-resistant/relapsed primary immune thrombocytopenia (ITP).
Eligibility criteria
Qualifiers
Primary ITP if aged ⩾18 years;
With an average of two platelet counts ⩾1 day apart of <30×10^9/L during screening and no single platelet count >35×10^9/L within 2 weeks before study treatment;
Patients who have previously received at least one first-line standard therapy for ITP (corticosteroid and/or intravenous immunoglobulin) with unsustained efficacy, relapse, intolerance to standard therapy, or insufficient response.
Disqualifiers
Pregnant or lactating women, and who were possibly pregnant, planning to become pregnant, or who had partners planning to become pregnant;
With active malignancy or a history of malignant tumor;
Having experienced severe bacterial, viral, fungal or parasitic infection within the past 4 weeks;
With a history of symptomatic herpes zoster infection within 12 weeks prior to screening;
Trial design
Treatments tested in this trial
- all-trans retinoic acid (ATRA)
- Placebo
Treatment groups
192 Participants
are divided into 2 treatment groupsSponsors and collaborators
Peking University People's Hospital
Lead sponsor
Peking University First Hospital
Collaborator
Beijing Friendship Hospital
Collaborator
Beijing Tongren Hospital
Collaborator
Peking University Third Hospital
Collaborator
Beijing Hospital
Collaborator
Source ClinicalTrials.gov