Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic Anemia

August 4, 2016 updated by: ZhongHong Shao, Tianjin Medical University General Hospital
Efficacy and Safety of Recombinant human thrombopoietin in patients with severe aplastic anemia and very severe aplastic anemia, a randomized, double-blind, placebo-controlled, II phase, multi-center clinical research.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

rhTPO

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300052

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to provide written informed consent
  • Have severe or very severe aplastic anemia

Exclusion Criteria:

  • Have diagnosis of Fanconi anemia
  • Have infection not adequately responding to appropriate therapy
  • Have Paroxysmal Nocturnal Hemoglobinuria (PNH) clone size in neutrophils of greater than or equal to 50%
  • Have creatinine and/or blood urea nitrogen (BUN) ≥2 times the upper limit of normal
  • Have serum bilirubin ≥ 1.5 times the upper limit of normal, or ≥4.0 times the upper limit of normal if the patient has been treated with Anti-Thymocytes globulin（ATG） within three weeks of screening.
  • Have glutamic-oxaloacetic transaminase （AST） and/or glutamic-pyruvic transaminase （ALT） ≥ 3 times the upper limit of normal
  • Are female and are nursing or pregnant or are unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater
  • Have had other Thrombopoietin (TPO-R) agonists medication in the previous 4 weeks.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: rhTPO
rhTPO injection
Drug: rhTPO
rhTPO
Other Names:
  • Recombinant Human Thrombopoietin
Placebo Comparator: control
without rhTPO injection
Drug: placebo
without rhTPO
Other Names:
  • without Recombinant Human Thrombopoietin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to platelet transfusion independence in patients at 6 month
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Time to patients achieve a platelet count 30×10^9/L, 50×10^9/L or100×10^9/L
Time Frame: up to 1year
up to 1year
Overall response rate up to 1 year after Immunosupressive therapy.
Time Frame: up to 1 year
up to 1 year
Megakaryocyte, granulocyte and erythrocyte recovery in bone marrow up to 1 year after IST.
Time Frame: up to 1 year
up to 1 year
Time to red blood cell/platelet transfusion independence in patients up to 1 year after IST
Time Frame: up to 1 year
up to 1 year
Percentage of patients achieve red blood cell/platelet transfusion independence at 3, 6, 9 and 12 months after IST.
Time Frame: up to 1 year
up to 1 year
Intervals of red blood cell/platelet transfusion up to 1 year after IST.
Time Frame: up to 1 year
up to 1 year
The reticulocyte count of patients up to 1 year after IST.
Time Frame: up to 1 year
up to 1 year
Hospitalization days of patients.
Time Frame: up to 1 year
up to 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: up to 1 year
up to 1 year
Median hematopoietic response rate up to 1 year after IST.
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Anticipated)

July 1, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

August 4, 2016

First Posted (Estimate)

August 5, 2016

Study Record Updates

Last Update Posted (Estimate)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 4, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB2013-066-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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