NCT02391272

Brief Summary

The project was undertaking by Qilu Hospital of Shandong University and other well-known hospitals in China. Aims at evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

March 2, 2015

Last Update Submit

March 19, 2020

Conditions

Immune ThrombocytopeniaPregnancy

Keywords

recombinant human thrombopoietinimmune thrombocytopeniapregnancy

Outcome Measures

Primary Outcomes (6)

  • Early response 1- Response rate (CR+R)

    Response rate (CR+R) at the 7th day. CR is defined as platelet count ≥ 100×10\^9/L, and R is defined as platelet count of \>30×10\^9/L with at least a doubling of the baseline value.

    7th day

  • Early response 2- Response rate (CR+R)

    Response rate (CR+R) at the 14th day.

    14th day

  • Long-time response 1 (Platelet count)

    Platelet count at 10th week.

    10th week

  • Long-time response 2 (Platelet count)

    Platelet count at 40 weeks' gestation.

    40 weeks' gestation

  • Long-time response 3 (Platelet count)

    Platelet count one month after delivery.

    one month after delivery

  • Safety (Adverse events)

    Adverse events in patients and infants.

    6 months after delivery

Study Arms (1)

rhTPO

EXPERIMENTAL

rhTPO will be given intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10\^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week.

Drug: rhTPO

Interventions

rhTPODRUG
Also known as: TPIAO
rhTPO

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subject is between 18-50 years old.
  • After 12 weeks gestation.
  • Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
  • Patients who have no response or relapsed after Corticosteroid or IVIG.
  • Patients developed refractoriness to platelet transfusion.
  • To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
  • Willing and able to sign written informed consent.

You may not qualify if:

  • Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
  • Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
  • Current HIV infection or hepatitis B virus or hepatitis C virus infections.
  • Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
  • Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
  • Patients who are deemed unsuitable for the study by the investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, China

Location

Related Publications (1)

  • Kong Z, Qin P, Xiao S, Zhou H, Li H, Yang R, Liu X, Luo J, Li Z, Ji G, Cui Z, Bai Y, Wu Y, Shao L, Peng J, Ma J, Hou M. A novel recombinant human thrombopoietin therapy for the management of immune thrombocytopenia in pregnancy. Blood. 2017 Aug 31;130(9):1097-1103. doi: 10.1182/blood-2017-01-761262. Epub 2017 Jun 19.

    PMID: 28630121DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaHemorrhagic DisordersAutoimmune DiseasesImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Ming Hou, MD PhD

    Shandong University Qilu Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Director

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 18, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2015

Study Completion

June 1, 2016

Last Updated

March 20, 2020

Record last verified: 2016-03

Locations

CN(1)