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To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).

NCT04253236 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2022-07-28

Study results available
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Summary

This is a Phase 2 non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 in patients with Warm Autoimmune Hemolytic Anemia.

Conditions

Interventions

DRUG

RVT-1401 680 mg/weekly

Non-randomized subjects will receive subcutaneous injection of 680 mg weekly for 12 weeks of RVT-1401

DRUG

RVT-1401 340 mg/weekly

Non-randomized subjects will receive subcutaneous injection of 340 mg weekly for 12 weeks of RVT-1401

Sponsors & Collaborators

  • Immunovant Sciences GmbH

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2021-04-01
Completion
2021-04-01
FDA Drug
Yes

Countries

  • United States
  • Israel
  • South Korea
  • Spain
  • Thailand
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04253236 on ClinicalTrials.gov