A Multicenter, Randomized, Double-blind, Placebo-parallel, Phase II Clinical Trial of the Efficacy and Safety of Anfibatide in Treating Patients With Acquired Thrombotic Thrombocytopenic Purpura (TTP)

A Clinical Study of Anfibatide in Acquired Thrombotic Thrombocytopenic Purpura (TTP)

Sponsors

Lead sponsor: Lee's Pharmaceutical Limited

Source Lee's Pharmaceutical Limited
Brief Summary

This is a multicenter, randomized, double-blind, parallel, placebo-controlled phase II clinical study. It is planned to recruit 74 patients with acquired thrombotic thrombocytopenic purpura (TTP). To evaluate the efficacy and safety of Anfibatide as an adjuvant therapy for plasma exchange in patients with acquired TTP.

Detailed Description

The study will consist of 3 periods: screening(up to 7 days), treatment and follow-up(up to 3 months). Subjects are assigned in a 1:1 ratio to Anfibatide or placebo during plasma exchange with the use of a computerized randomization schedule. The administration is 5 IU/60kg intravenous infusion and 0.002 IU/kg/h continuous intravenous infusion. Plasma exchange as the main treatment method is performed daily on the 5th day of solstice and then adjusted to every other day. Fresh frozen plasma(FFP)and cryoprecipitate-reduced plasma are preferred. Subjects will receive the study drug immediately after daily plasma exchange.

Overall Status Not yet recruiting
Start Date July 2019
Completion Date November 2021
Primary Completion Date July 2021
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Time to response of treatment up to 21days
Secondary Outcome
Measure Time Frame
Remission rate up to 21days
Enrollment 74
Condition
Intervention

Intervention type: Drug

Intervention name: Anfibatide

Description: 5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion

Arm group label: Anfibatide

Other name: Anti-platelet thrombolysin for injection

Intervention type: Drug

Intervention name: Placebos

Description: 5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion

Arm group label: Placebo

Eligibility

Criteria:

Inclusion Criteria:

1. Female and male subjects with 18 years of age or older.

2. Subjects with diagnosis of TTP.

3. Necessitating plasma exchange.

4. Obtained, signed and dated informed consent.

Exclusion Criteria:

1. Platelet count greater or equal to 100*10^9/μL.

2. Severe heart, liver and kidney dysfunction, including those with glutamic-pyruvic transaminase ≥ 5xULN,glomerular filtration rate <30ml/min.

3. Uncontrolled severe active infection.

4. Known congenital TTP.

5. Subjects with malignant tumors in the past 5 years.

6. Other diseases that cause microangiopathy hemolytic anemia and thrombocytopenia, such as disseminated intravascular coagulation (DIC), antiphospholipid antibody syndrome, hemolytic uremic syndrome, malignant hypertension, and transplant-related microangiopathy.

7. Pregnant or lactating women. Subjects of reproductive age, are unable to use effective contraceptive methods during the study period.

8. Severe active bleeding or progressive aggravation of bleeding symptoms.

9. Subjects who have received plasmapheresis during the treatment of the onset of the disease.

10. Subject is participating in other clinical stuy or is less than 3 months away from the end of previous clinical study.

11. Subject who have participated in other clinical trials related to Anfibatide.

12. Severe or life threatening clinical condition other than TTP that would impair participation in the trial.

13. Life expectation less than 1 week.

14. Known to be allergic to the drugs or ingredients in the study.

15. Inability to follow programme requirements and procedures.

16. Subjects who are not eligible to participate in this clinical study as determined by the investigator.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Weili Zhao, MD Study Director Shanghai Ruijing Hospital
Overall Contact

Last name: Weili Zhao, MD

Phone: 13512112076

Email: [email protected]

Location
facility contact Shanghai Ruijing Hospital Weili Zhao, MD 13512112076 [email protected]
Location Countries

China

Verification Date

July 2019

Responsible Party

Responsible party type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Anfibatide

Arm group type: Experimental

Arm group label: Placebo

Arm group type: Placebo Comparator

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov