Health TrialsbyHealthPanel

TPO-RA Plus Baricitinib vs. TPO-RA for ITP

ConditionITP - Immune Thrombocytopenia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeking University People's Hospital

About this trial

This is a prospective, randomized, controlled trial. ITP patients who failed prior full-does TPO-RA monotheray for 14 days. Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone. Patients are randomly assigned at a 1:1 ratio to receive baricitinib plus TPO-RA or TPO-RA alone. The primary endpoint was the 14-day overall response rate without any rescue therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years old;

Patients diagnosed with primary ITP who failed to achieve a response after 14 days of full-dose TPO-RA therapy;

Patients with baseline platelet count less than 30×10⁹/L, or those with baseline platelet count ranging from 30×10⁹/L to 50×10⁹/L accompanied by clinically significant bleeding (WHO bleeding score ≥2).

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

  • Baricitinib

    Drug

    Oral baricitinib is given at a dose of 2 mg twice daily for 14 days.

  • TPO-RA

    Drug

    Hetrombopag is given at an initial dose of 7.5 mg once daily for 14 days; eltrombopag is given at an initial dose of 75 mg once daily for 14 days

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Combined therapyExperimental treatment 2 interventions
Group B: MonotherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

14-day Overall response rate

Overall response was defined as platelet count over 30,000/μL and at least a 2-fold increase of the baseline count in the absence of bleeding and rescue therapy.

Time frame
From enrollment to the end of treatment at 14 days

Secondary outcomes

1

14-day Complete response (CR) rate

Complete response (CR) was defined as platelet count over 100,000/μL and absence of bleeding.

Time frame
From enrollment to the end of treatment at 14 days
2

28-day ovrall response rate

Overall response was defined as platelet count over 30,000/μL and at least a 2-fold increase of the baseline count and absence of bleeding.

Time frame
From enrollment to the end of treatment at 28 days
3

28-day CR rate

Complete response (CR) was defined as platelet count over 100,000/μL and absence of bleeding.

Time frame
From enrollment to the end of treatment at 28 days
4

Time to response (TTR)

The time from treatment initiation to achieve a CR or a R.

Time frame
From the start of study treatment (Day 1) up to day 14

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University People's Hospital

Lead sponsor

Source ClinicalTrials.gov

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