Extension Study of Hetrombopag in Severe Aplastic Anemia

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04961710
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 63.4
• Patients Per Site Per Month: 2.8

Study Details

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 All subjects who have completed or withdrawn from the HR-TPO-SAA-III study will voluntarily participate in this extension study.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.

Condition or Disease	Intervention/Treatment	Phase
Treatment-naive Severe Aplastic Anemia	Drug: Hetrombopag Olamine; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 180 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Extension Study of Hetrombopag Olamine in Patients With Treatment-naive Severe Aplastic Anemia
• Actual Study Start Date: Sep 19, 2019
• Anticipated Primary Completion Date: Nov 30, 2024
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hetrombopag Olamine	Drug: Hetrombopag Olamine; Hetrombopag Olamine; once daily
Placebo Comparator: Placebo	Drug: Placebo; Placebo; once daily

Outcome Measures

Primary Outcome Measures

1. The ratio of subjects with clonal evolution at 6 months and 18 months [6 months and 18 months]

2. All SIEs, regardless of whether they are related to the investigational product [3 years]

3. All SAEs, regardless of whether they are related to the investigational product [3 years]

4. All AEs resulting in discontinuation and withdrawal from study [3 years]

Secondary Outcome Measures

1. Red blood cell count [by 1day visit]

2. Hemoglobin [by 1day visit]

3. Platelet count [by 1day visit]

4. White blood cell count [by 1day visit]

5. Neutrophil count [by 1day visit]

6. Reticulocyte count [by 1day visit]

7. The 6-month and 18-month survival rates of subjects [6 months and 18 months]

8. The recurrence rates at 6 months and 18 months [6 months and 18 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects who have completed or withdrawn from the HR-TPO-SAA-III study

2. Subjects who have signed the informed consent form

3. 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

4. Subjects who have completed the end-of-treatment evaluation in the original study

Exclusion Criteria:

1. Any unstable situation or situation that will compromise the safety of the subject

2. Evidence of clonal cytogenetic abnormalities at the end-of-treatment examination of the HR-TPO-SAA-III study

3. Subjects with uncontrollable hemorrhage and/or infection after standard treatment

4. Subjects who have experienced deep vein thrombosis, myocardial infarction, stroke, or peripheral arterial embolism within 1 year

5. Any situation that may compromise the subject and the safety or compliance thereof during the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Blood Diseases Hospital, Chinese Academy of Medical Sciences	Tianjin	Tianjin	China	300020

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04961710
• Other Study ID Numbers: HR-TPO-SAA-III-EXT
• First Posted: Jul 14, 2021
• Last Update Posted: Jul 14, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Anemia; Anemia, Aplastic

Study Results

No Results Posted as of Jul 14, 2021