Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • all-trans retinoic acid (ATRA)

    Drug

    10mg twice daily ×24 weeks

  • Placebo

    Drug

    10mg twice daily ×24 weeks

Treatment groups

192 Participants
are divided into 2 treatment groups
Group A: ATRAExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Durable platelet response

Platelet count of ⩾50 × 10\^9/L or between ⩾30 × 10\^9/L and \<50 × 10\^9/L and at least doubled from baseline on at least four of six scheduled visits between weeks 14 and 24

Time frame
Up to week 24

Secondary outcomes

1

24-week overall response rate

From enrollment to the end of week 24, the proportion of patients with at least one platelet count of ≥50×10⁹/L or between 30 × 10\^9/L and 50 × 10\^9/L plus at least doubled from baseline

Time frame
Up to week 24
2

12-week overall response rate

From enrollment to the end of week 12, the proportion of patients with at least one platelet count of ≥50×10⁹/L or between 30 × 10\^9/L and 50 × 10\^9/L plus at least doubled from baseline

Time frame
Up to week 12
3

Consecutive Increased Platelet Counts (≥2 Consecutive PLT ≥ 30×10^9/L)

The proportion of participants who achieved platelet counts ≥ 30×10\^9/L and at least doubled from baseline at two consecutive visits

Time frame
Up to week 24
4

Consecutive Increased Platelet Counts (≥2 Consecutive PLT ≥ 50×10^9/L)

The proportion of patients with two consecutive platelet counts of 50×10⁹/L or more and doubling from the baseline count

Time frame
Up to week 24

Other outcomes

Sponsors and contacts

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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

This trial is not recruiting at the moment. You can still explore other options: