rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP

• Register: ClinicalTrials.gov
• Last refreshed on: 2 May 2016
• Main ID: NCT01734044
• Date of registration: 21/11/2012
• Prospective Registration: No
• Primary sponsor: Shandong University
• Public title: rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP
• Scientific title: A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
• Date of first enrolment: July 2012
• Target sample size: 158
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01734044
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

China

Contacts

• Name: Ming Hou, Dr.
• Affiliation: Shandong University

Key inclusion & exclusion criteria

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 [2] 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Idiopathic Thrombocytopenic Purpura

Purpura

Intervention(s)

Drug: recombinant human thrombopoietin (rhTPO); dexamethasone

Drug: Dexamethasone

Primary Outcome(s)

Evaluation of platelet response [Time Frame: up to 1 year per subject]

Evaluation of platelet response (R) [Time Frame: up to 1 year per subject]

Secondary ID(s)

ITP-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Zhejiang Provincial Hospital of TCM

Anhui Medical University

China Medical University, China

Shenzhen Second People's Hospital

The First Affiliated Hospital of Dalian Medical University

Shandong Provincial Hospital

The Affiliated Hospital of the Chinese Academy of Military Medical Sciences