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Extension Study of Hetrombopag in Severe Aplastic Anemia

Primary Purpose

Treatment-naive Severe Aplastic Anemia

Status

Recruiting

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Hetrombopag Olamine

Placebo

About this trial

This is an interventional treatment trial for Treatment-naive Severe Aplastic Anemia

Eligibility Criteria

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

Inclusion Criteria:

Subjects who have completed or withdrawn from the HR-TPO-SAA-III study
Subjects who have signed the informed consent form
Female and male subjects of childbearing age who agree to take adequate contraceptive measures during the extension study period and within 28 days after the last dose
Subjects who have completed the end-of-treatment evaluation in the original study

Exclusion Criteria:

Any unstable situation or situation that will compromise the safety of the subject
Evidence of clonal cytogenetic abnormalities at the end-of-treatment examination of the HR-TPO-SAA-III study
Subjects with uncontrollable hemorrhage and/or infection after standard treatment
Subjects who have experienced deep vein thrombosis, myocardial infarction, stroke, or peripheral arterial embolism within 1 year
Any situation that may compromise the subject and the safety or compliance thereof during the study

Sites / Locations

Blood Diseases Hospital, Chinese Academy of Medical SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Hetrombopag Olamine

Placebo

Arm Description

Outcomes

Primary Outcome Measures

The ratio of subjects with clonal evolution at 6 months and 18 months

All SIEs, regardless of whether they are related to the investigational product

All SAEs, regardless of whether they are related to the investigational product

All AEs resulting in discontinuation and withdrawal from study

Secondary Outcome Measures

Red blood cell count

Hemoglobin

Platelet count

White blood cell count

Neutrophil count

Reticulocyte count

The 6-month and 18-month survival rates of subjects

The recurrence rates at 6 months and 18 months

Full Information

NCT ID

NCT04961710

First Posted

July 12, 2021

Last Updated

July 13, 2021

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04961710

Brief Title

Extension Study of Hetrombopag in Severe Aplastic Anemia

Official Title

Extension Study of Hetrombopag Olamine in Patients With Treatment-naive Severe Aplastic Anemia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 19, 2019 (Actual)

Primary Completion Date

November 30, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This is a multicenter, placebo-control, phase 3 study of hetrombopag in patients with treatment-naive severe aplastic anemia. All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study. Subjects will receive the same study drug (hetrombopag or placebo) as in study HR-TPO-SAA-III, with the same doses and administration schedule or with modifications based on the actual conditions. The primary objective of this extension study is to give the subjects participating in the HR-TPO-SAA-III study the continued access to the study drug (hetrombopag or placebo) after the completion of the HR-TPO-SAA-III study.

6. Conditions and Keywords

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

Treatment-naive Severe Aplastic Anemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Non-Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hetrombopag Olamine

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Hetrombopag Olamine

Intervention Description

Hetrombopag Olamine; once daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo; once daily

Primary Outcome Measure Information:

Title

The ratio of subjects with clonal evolution at 6 months and 18 months

Time Frame

6 months and 18 months

Title

All SIEs, regardless of whether they are related to the investigational product

Time Frame

3 years

Title

All SAEs, regardless of whether they are related to the investigational product

Time Frame

3 years

Title

All AEs resulting in discontinuation and withdrawal from study

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Red blood cell count

Time Frame

by 1day visit

Title

Hemoglobin

Time Frame

by 1day visit

Title

Platelet count

Time Frame

by 1day visit

Title

White blood cell count

Time Frame

by 1day visit

Title

Neutrophil count

Time Frame

by 1day visit

Title

Reticulocyte count

Time Frame

by 1day visit

Title

The 6-month and 18-month survival rates of subjects

Time Frame

6 months and 18 months

Title

The recurrence rates at 6 months and 18 months

Time Frame

6 months and 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who have completed or withdrawn from the HR-TPO-SAA-III study Subjects who have signed the informed consent form Female and male subjects of childbearing age who agree to take adequate contraceptive measures during the extension study period and within 28 days after the last dose Subjects who have completed the end-of-treatment evaluation in the original study Exclusion Criteria: Any unstable situation or situation that will compromise the safety of the subject Evidence of clonal cytogenetic abnormalities at the end-of-treatment examination of the HR-TPO-SAA-III study Subjects with uncontrollable hemorrhage and/or infection after standard treatment Subjects who have experienced deep vein thrombosis, myocardial infarction, stroke, or peripheral arterial embolism within 1 year Any situation that may compromise the subject and the safety or compliance thereof during the study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yaqi Shen

Phone

021-61053363

yaqi.shen@hengrui.com

Facility Information:

Facility Name

Blood Diseases Hospital, Chinese Academy of Medical Sciences

City

Tianjin

State/Province

Tianjin

ZIP/Postal Code

300020

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fengkui Zhang, Doctor

12. IPD Sharing Statement

Learn more about this trial

Extension Study of Hetrombopag in Severe Aplastic Anemia

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