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Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

Primary Purpose

Purpura, Idiopathic Thrombocytopenic Purpura

Status

Withdrawn

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

recombinant human thrombopoietin (rhTPO); rituximab

Dexamethasone

About this trial

This is an interventional treatment trial for Purpura focused on measuring Recombinant Human Thrombopoietin, rhTPO, Rituximab, Dexamethasone

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meet the diagnostic criteria for immune thrombocytopenia.
Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years.
To show a platelet count < 30×10^9/L, and with bleeding manifestations.
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
Willing and able to sign written informed consent

Exclusion Criteria:

Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
Received high-dose steroids or intravenous immunoglobulin transfusion(IVIG) in the 3 weeks prior to the start of the study.
Current HIV infection or hepatitis B virus or hepatitis C virus infections.
Severe medical condition (lung, hepatic or renal disorder) other than 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)
Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
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.

Sites / Locations

Qilu Hospital, Shandong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

combinant treatment group

single treatment group

Arm Description

120 enrolled patients are randomly picked up to take Rituximab in combination with rhTPO at the indicated dose.

120 enrolled patients are randomly picked up to take dexamethasone at the indicated dose.

Outcomes

Primary Outcome Measures

Evaluation of platelet response(Chronic ITP)

Chronic ITP is defined as having platelet count less than 100×10^9/L,lasting for more than 12 months.

Evaluation of platelet response (Complete Response)

CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L without recurrence of thrombocytopenia

Evaluation of platelet response (R)

R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia

Secondary Outcome Measures

Full Information

NCT ID

NCT01734057

First Posted

November 21, 2012

Last Updated

April 18, 2016

Sponsor

Shandong University

Collaborators

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences, Anhui Medical University, The First Affiliated Hospital of Dalian Medical University, Shandong Provincial Hospital, Shenzhen Second People's Hospital, China Medical University, China, Zhejiang Provincial Hospital of TCM

1. Study Identification

Unique Protocol Identification Number

NCT01734057

Brief Title

Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

Official Title

A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

Study Type

Interventional

2. Study Status

Record Verification Date

November 2012

Overall Recruitment Status

Withdrawn

Why Stopped

No eligible patient was enrolled.

Study Start Date

July 2012 (undefined)

Primary Completion Date

July 2013 (Anticipated)

Study Completion Date

October 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shandong University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining with Rituximab for the treatment of adults with primary immune thrombocytopenia (ITP), compared to conventional high-dose dexamethasone therapy.

Detailed Description

The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 240 primary ITP adult patients from 14 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300Units/kgfor 14 consecutive days, following with a flexible dosage depending on platelet count until the 28th day), combining with rituximab (given intravenously at a dose of 100 mg weekly for 4 weeks, i.e. Day 1, 8, 15, 22; the others are selected to receive high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4 days). Platelet count was evaluated before and after treatment,in order to report the conversion ratio of primary ITP to chronic ITP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Purpura, Idiopathic Thrombocytopenic Purpura

Keywords

Recombinant Human Thrombopoietin, rhTPO, Rituximab, Dexamethasone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

combinant treatment group

Arm Type

Experimental

Arm Description

120 enrolled patients are randomly picked up to take Rituximab in combination with rhTPO at the indicated dose.

Arm Title

single treatment group

Arm Type

Active Comparator

Arm Description

120 enrolled patients are randomly picked up to take dexamethasone at the indicated dose.

Intervention Type

Drug

Intervention Name(s)

recombinant human thrombopoietin (rhTPO); rituximab

Other Intervention Name(s)

Recombinant Human Thrombopoietin, Recombinant Human TPO, rhTPO combine with Rituximab, Recombinant Human Thrombopoietin combine with Rituximab, Recombinant Human TPO combine with Rituximab

Intervention Description

patients in recombination treatment group take Rituximab( intravenously ,100 mg weekly for 4 consecutive weeks); in combination with rhTPO( subcutaneously , 300U/kg for 14 consecutive days,followed by flexible treating dosage so as to keep the platelet count above 50×10^9/L until the 28th day)

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

Patients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.

Primary Outcome Measure Information:

Title

Evaluation of platelet response(Chronic ITP)

Description

Chronic ITP is defined as having platelet count less than 100×10^9/L,lasting for more than 12 months.

Time Frame

up to 1 year per subject

Title

Evaluation of platelet response (Complete Response)

Description

CR. A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L without recurrence of thrombocytopenia

Time Frame

up to 1 year per subject

Title

Evaluation of platelet response (R)

Description

R. A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia

Time Frame

up to 1 year per subject

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meet the diagnostic criteria for immune thrombocytopenia. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years. To show a platelet count < 30×10^9/L, and with bleeding manifestations. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Willing and able to sign written informed consent Exclusion Criteria: Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. Received high-dose steroids or intravenous immunoglobulin transfusion(IVIG) in the 3 weeks prior to the start of the study. Current HIV infection or hepatitis B virus or hepatitis C virus infections. Severe medical condition (lung, hepatic or renal disorder) other than 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) Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ming Hou, Dr.

Organizational Affiliation

Shandong University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Qilu Hospital, Shandong University

City

Jinan

State/Province

Shandong

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

18510702

Citation

Medeot M, Zaja F, Vianelli N, Battista M, Baccarani M, Patriarca F, Soldano F, Isola M, De Luca S, Fanin R. Rituximab therapy in adult patients with relapsed or refractory immune thrombocytopenic purpura: long-term follow-up results. Eur J Haematol. 2008 Sep;81(3):165-9. doi: 10.1111/j.1600-0609.2008.01100.x. Epub 2008 May 27.

Results Reference

result

PubMed Identifier

19846889

Citation

Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.

Results Reference

result

PubMed Identifier

19005182

Citation

Rodeghiero F, Stasi R, Gernsheimer T, Michel M, Provan D, Arnold DM, Bussel JB, Cines DB, Chong BH, Cooper N, Godeau B, Lechner K, Mazzucconi MG, McMillan R, Sanz MA, Imbach P, Blanchette V, Kuhne T, Ruggeri M, George JN. Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group. Blood. 2009 Mar 12;113(11):2386-93. doi: 10.1182/blood-2008-07-162503. Epub 2008 Nov 12.

Results Reference

result

PubMed Identifier

12944568

Citation

Cheng Y, Wong RS, Soo YO, Chui CH, Lau FY, Chan NP, Wong WS, Cheng G. Initial treatment of immune thrombocytopenic purpura with high-dose dexamethasone. N Engl J Med. 2003 Aug 28;349(9):831-6. doi: 10.1056/NEJMoa030254.

Results Reference

result

PubMed Identifier

17077333

Citation

Mazzucconi MG, Fazi P, Bernasconi S, De Rossi G, Leone G, Gugliotta L, Vianelli N, Avvisati G, Rodeghiero F, Amendola A, Baronci C, Carbone C, Quattrin S, Fioritoni G, D'Alfonso G, Mandelli F; Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) Thrombocytopenia Working Party. Therapy with high-dose dexamethasone (HD-DXM) in previously untreated patients affected by idiopathic thrombocytopenic purpura: a GIMEMA experience. Blood. 2007 Feb 15;109(4):1401-7. doi: 10.1182/blood-2005-12-015222. Epub 2006 Oct 31.

Results Reference

result

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Recombinant Human Thrombopoietin (rhTPO) Combining Rituximab Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)

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