A Study to Evaluate Ofirnoflast in Adults With Very Low- to Intermediate-risk Myelodysplastic Syndromes Requiring Red Blood Cell Transfusions

ClinicalTrials.gov ID: NCT07738510

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ClinicalTrials.gov public records Last synced Nov 13, 2026, 7:27 PM EST

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Official title

A Phase 2b, Multicenter, Open-Label, Dose-Escalation, and Randomized Dose-Optimization Study of Ofirnoflast (HT-6184) for the Treatment of Myelodysplastic Syndromes in Adults With Very Low- to Intermediate-Risk Myelodysplastic Syndromes Requiring Red Blood Cell Transfusions

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The primary objective of this study is to two part. First, dose selection for dose optimization based on safety of ofirnoflast. Second, to evaluate the efficacy of ofirnoflast administered in the study population. The secondary objectives of this study are to evaluate the extended hematologic response to ofirnoflast, to assess the safety and tolerability of ofirnoflast during dose optimization, and to evaluate hematologic improvement with ofirnoflast treatment.

Study identification

NCT ID: NCT07738510
Recruitment status: Not yet recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Halia Therapeutics, Inc.; Industry
Enrollment: 70 participants

Conditions and interventions

Conditions

Interventions

Ofirnoflast Drug

Drug

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 2026 (Estimated)
Primary completion: Oct 2028 (Estimated)
Completion: Dec 2028 (Estimated)
Last update posted: Nov 10, 2026

2026 – 2028

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Cleveland Clinic	Cleveland	Ohio	44195	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07738510, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 10, 2026 · Synced Nov 13, 2026