UnknownPhase 2

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

China74 participantsStarted 2019-07

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Female and male subjects with 18 years of age or older.
✓. Subjects with diagnosis of TTP.
✓. Necessitating plasma exchange.
✓. Obtained, signed and dated informed consent.

Exclusion criteria

✕. Platelet count greater or equal to 100\*10\^9/μL.
✕. Severe heart, liver and kidney dysfunction, including those with glutamic-pyruvic transaminase ≥ 5xULN，glomerular filtration rate \<30ml/min.
✕. Uncontrolled severe active infection.
✕. Known congenital TTP.
✕. Subjects with malignant tumors in the past 5 years.
✕. 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.
✕. Pregnant or lactating women. Subjects of reproductive age, are unable to use effective contraceptive methods during the study period.
✕. Severe active bleeding or progressive aggravation of bleeding symptoms.

What they're measuring

Time to response of treatment

Timeframe: up to 21days

Trial details

NCT IDNCT04021173

SponsorLee's Pharmaceutical Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07

Contact for this trial

Weili Zhao, MD

13512112076 zhaoweili-sih@163.com

View on ClinicalTrials.gov More Acquired Thrombotic Thrombocytopenic Purpura trials