A Study of H3B-8800 (RVT-2001) in Participants With Lower Risk Myelodysplastic Syndromes

NCT02841540 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 127

Last updated 2024-02-14

No results posted yet for this study

Summary

A Phase 1, an Open-label, Multicenter Phase 1 Trial to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Splicing Modulator H3B-8800 (RVT-2001) for Subjects With Myelodysplastic Syndromes, Acute Myeloid Leukemia, and Chronic Myelomonocytic Leukemia

Conditions

Interventions

DRUG

H3B-8800 (RVT-2001)

H3B-8800 (RVT-2001) orally at specified doses and schedules.

Sponsors & Collaborators

  • Hemavant Sciences GmbH

    lead INDUSTRY

Principal Investigators

  • Keisuke Kuida, MD, PhD · Hemavant Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-06
Primary Completion
2024-02-13
Completion
2024-02-13
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Italy
  • South Korea
  • Spain
  • Taiwan

Study Locations

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Entities

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 NCT02841540 on ClinicalTrials.gov