NCT04021173

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
74

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

July 15, 2019

Last Update Submit

July 15, 2019

Conditions

Acquired Thrombotic Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

  • Time to response of treatment

    Time to response of treatment ,defined by a recovery of platelets ≥100\*10\^9/l

    up to 21days

Secondary Outcomes (1)

  • Remission rate

    up to 21days

Other Outcomes (7)

  • Complete remission rate

    up to 21 days

  • Number of plasma exchange

    up to 21 days

  • Volume of plasma

    up to 21 days

  • +4 more other outcomes

Study Arms (2)

Anfibatide

EXPERIMENTAL
Drug: Anfibatide

Placebo

PLACEBO COMPARATOR
Drug: Placebos

Interventions

AnfibatideDRUG

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

Also known as: Anti-platelet thrombolysin for injection
Anfibatide
PlacebosDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Subjects who have received plasmapheresis during the treatment of the onset of the disease.
  • Subject is participating in other clinical stuy or is less than 3 months away from the end of previous clinical study.
  • Subject who have participated in other clinical trials related to Anfibatide.
  • Severe or life threatening clinical condition other than TTP that would impair participation in the trial.
  • Life expectation less than 1 week.
  • Known to be allergic to the drugs or ingredients in the study.
  • Inability to follow programme requirements and procedures.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Ruijing Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Purpura, Thrombotic Thrombocytopenic

Interventions

agkisacucetin protein, Agkistrodon acutusInjections

Condition Hierarchy (Ancestors)

Purpura, ThrombocytopenicPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesThrombotic MicroangiopathiesThrombocytopeniaBlood Platelet DisordersCytopeniaThrombophiliaHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Weili Zhao, MD

    Shanghai Ruijing Hospital

    STUDY DIRECTOR

Central Study Contacts

Weili Zhao, MD

CONTACT

13512112076zhaoweili-sih@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 16, 2019

Study Start

July 1, 2019

Primary Completion

July 1, 2021

Study Completion

November 1, 2021

Last Updated

July 17, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)