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Follow-up Study for Patients ...

Follow-up Study for Patients Who Completed Study ALX0681-C301 (Post-HERCULES)

Last Updated: 2022-03-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-06

Study Completion Date

2020-10-23

Brief Summary

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The objectives of this study were to evaluate long-term safety and efficacy of caplacizumab, to evaluate safety and efficacy of repeated use of caplacizumab and to characterize long-term impact of acquired thrombotic thrombocytopenic purpura (aTTP).

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Detailed Description

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Conditions

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Acquired Thrombotic Thrombocytopenic Purpura

Study Design

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Allocation Method

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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caplacizumab

Participants who completed study ALX0681-C301 (NCT02553317) with standard of care (plasma exchange \[PE\], corticosteroid and other immunosuppressive agents) or caplacizumab with PE and immunosuppressive agents were enrolled in study LTS16371. Participants upon each recurrence of aTTP in LTS16371 and not meeting any criteria (namely: pregnancy, history of severe and/or serious hypersensitivity reaction to investigational medicinal product \[IMP\], withdrawal before receiving IMP, received more than 1 PE) were treated with caplacizumab initial 10 milligrams (mg) intravenous dose followed by a daily 10 mg subcutaneous injections during the period of PE and for 30 days after stop of PE (and eventually 28-day extension period, if needed). Participants with or without recurrence were followed up twice yearly up to maximum of 36 months in LTS16371.

Group Type EXPERIMENTAL

Caplacizumab

Intervention Type BIOLOGICAL

Standard of Care

Intervention Type OTHER

• PE with plasma (e.g., fresh frozen plasma, solvent detergent/viral-inactivated plasma, cryosupernatant), • Corticosteroid treatment and • Use of other immunosuppressive agents (e.g., rituximab).

Interventions

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Caplacizumab

Intervention Type BIOLOGICAL

Standard of Care

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Completed the Final (28 day) follow-up visit in Study ALX0681-C301.
2. \>= 18 years of age at the time of signing the informed consent form.
3. Provided informed consent prior to initiation of any study specific activity/procedure.

Exclusion Criteria

1. Not being able/willing to comply with the study protocol procedures.
2. Currently enrolled in a clinical study with another investigational drug or device.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers