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

Acquired Thrombotic Thrombocytopenic Purpura Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04021173
• Other study ID #: APT-ZK-201901
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2019
• Est. completion date: November 2021

Study information

• Verified date: July 2019
• Source: Lee's Pharmaceutical Limited
• Contact: Weili Zhao, MD
• Phone: 13512112076
• Email: zhaoweili-sih[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 74
• Est. completion date: November 2021
• Est. primary completion date: July 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Thrombotic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombotic Thrombocytopenic

Intervention

Drug:
• Anfibatide
5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
• Placebos
5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion

Locations

Country	Name	City	State
China	Shanghai Ruijing Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complete remission rate	Number of subjects with complete remission	up to 21 days
Other	Number of plasma exchange	The number of plasma exchange to achieved remission.	up to 21 days
Other	Volume of plasma	The volume of plasma to achieved remission.	up to 21 days
Other	Time to achieve threshold values of biological markers.	The biological markers include platelets,LDH and creatinine.	up to 3 months
Other	Total mortality	Total mortality within the plasma exchange treatment period and the ensuing 30 days.	up to 21days and the ensuing 30 days
Other	Number of exacerbations of TTP and time to first exacerbation of TTP.	Exacerbation is defined as recurrent thrombocytopenia following a response and requiring a reinitiation of daily plasma exchange treatment after = 1 day but = 30 days of no plasma exchange treatment.	up to 1 month
Other	Number of subjects relapsing of TTP for maximum of 3 months and time to first relapse of TTP.	Relapse is defined as novo event of TTP that occurs later than 30 days after the last plasma exchange.	up to 3 months
Primary	Time to response of treatment	Time to response of treatment ,defined by a recovery of platelets =100*10^9/l	up to 21days
Secondary	Remission rate	Number of subjects with remission	up to 21days