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

Idiopathic Thrombocytopenic Purpura Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01734057
• Other study ID #: ITP-008
• Status: Withdrawn
• Phase: Phase 3
• First received: November 21, 2012
• Last updated: April 18, 2016
• Start date: July 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2012
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Meet the diagnostic criteria for immune thrombocytopenia.

2. Untreated hospitalized patients, may be male or female, between the ages of 18 ~ 80 years.

3. To show a platelet count < 30×10^9/L, and with bleeding manifestations.

4. Eastern Cooperative Oncology Group (ECOG) performance status = 2.

5. Willing and able to sign written informed consent

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.

2. Received high-dose steroids or intravenous immunoglobulin transfusion(IVIG) in the 3 weeks prior to the start of the study.

3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.

4. 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)

5. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.

6. 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.

7. Patients who are deemed unsuitable for the study by the investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• recombinant human thrombopoietin (rhTPO); rituximab
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)
• Dexamethasone
Patients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.

Locations

Country	Name	City	State
China	Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (8)

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

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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) Thr — View 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 — View 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. Internati — View 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, Kühne T, Ruggeri M, George JN. Standardization of terminology, d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 1 year per subject	Yes
Primary	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	up to 1 year per subject	Yes
Primary	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	up to 1 year per subject	Yes