An Investigation of rhTPO With Different Frequencies in the Management of ITP

NCT02139501 | Completed Phase 3 DMC

• 1 other identifier: ITP-Thrombopoietin
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The project was undertaking by Qilu Hospital of Shandong University and other well-known hospitals in China. In order to study the efficacy and safety of different dose and frequency Recombinant Human thrombopoietin in treating the primary immune thrombocytopenia (ITP)

Conditions

Immune Thrombocytopenia

Keywords

Recombinant Human Thrombopoietin; Dose and frequency; Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Early Response

  response rate (CR+R) at the 14th day and the 14th week from the initial injection of rhTPO. CR is defined as platelet count ≥ 100×10\^9/L, and R is defined as platelet count of \>30 × 10\^9/L with a least a doubling of the baseline value.

  14 days

Secondary Outcomes (1)

• Safety

  1 years

Study Arms (3)

rhTPO, 300Units/kg ,daily for 14 consecutive days

EXPERIMENTAL

10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 14 consecutive days

Drug: Recombinant Human Thrombopoietin (rhTPO)

rhTPO, 300Units/kg ,one times every other day for 7 times

EXPERIMENTAL

10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,one times every other day for 7 times.

Drug: Recombinant Human Thrombopoietin (rhTPO)

rhTPO, 300Units/kg ,daily for 7 consecutive days

EXPERIMENTAL

10 enrolled patients randomly receive rhTPO at a dose of 300Units/kg ,daily for 7consecutive days.

Drug: Recombinant Human Thrombopoietin (rhTPO)

Interventions

Recombinant Human Thrombopoietin (rhTPO) DRUG

rhTPO was given intravenously at a dose of300Units/kg ,daily for 14 consecutive days;at a dose of 300Units/kg ,one times every other day for 7 times; or at a dose of 300Units/kg ,daily for 7 consecutive days

Also known as: tpiao, Recombinant Human Thrombopoietin, Recombinant Human TPO

rhTPO, 300Units/kg ,daily for 14 consecutive days; rhTPO, 300Units/kg ,daily for 7 consecutive days; rhTPO, 300Units/kg ,one times every other day for 7 times

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Subject is ≥18 years old, may be male or female.
• Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
• Patients who have no response or relapsed after Corticosteroid.
• 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.
• Received high-dose steroids or 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 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)
• 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 .

Sponsors & Collaborators

• Shandong University: lead
• The First Affiliated Hospital of Dalian Medical University: collaborator
• Shandong Provincial Hospital: collaborator

Study Sites (1)

Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Thrombopoietin

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ming Hou, Dr

  Shandong University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: May 13, 2014
• First Posted: May 15, 2014
• Study Start: May 1, 2014
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 20, 2016

Record last verified: 2014-11

Locations

CN (1)