Trials Sponsors Conditions Drugs Pricing

Conditions

β Thalassemia

Keywords

TransfusionTDTNTDT

Outcome Measures

Primary Outcomes (1)

IMR-687 Safety and Tolerability
Incidence and severity of Adverse Events Incidence and severity of Serious Adverse Events
Baseline to Week 40

Secondary Outcomes (8)

TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 12 to Week 24
Baseline to Week 24
NTDT Patients: Proportion of Subjects With an Increase From Baseline of Hb at Week 12 to Week 24 in the Absence of Transfusions.
Baseline to Week 24
NTDT Patients: Proportion of Subjects With an Increase From Baseline of ≥3% in Mean HbF Values at Week 12 to Week 24 in Absence of Transfusions
Baseline to Week 24
TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥33% Hematological Improvement From Week 24 to Week 36
Baseline to Week 36
TDT Patients: Reduction in Red Blood Cell (RBC) Transfusion Burden With ≥50 % Hematological Improvement From Week 12 to Week 24
Baseline to Week 24
+3 more secondary outcomes

Study Arms (3)

Lower Dose IMR-687

EXPERIMENTAL

Oral administration of once daily IMR-687

Drug: IMR-687

Higher dose IMR-687

EXPERIMENTAL

Oral administration of once daily IMR-687

Drug: IMR-687

Placebo

PLACEBO COMPARATOR

Oral administration of once daily placebo

Drug: Placebo

Interventions

IMR-687Drug

Oral administration of once daily IMR-687

Higher dose IMR-687Lower Dose IMR-687

PlaceboDrug

Oral administration of once daily Placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Documented diagnosis of β-thalassemia or HbE/ β-thalassemia in their medical history. Concomitant alpha gene deletion, duplication, or triplication is allowed.
Documentation of the dates of transfusion events and the number of all pRBC units per event within the 12 weeks prior to the Baseline (Day 1) visit. .

Sponsors & Collaborators

Imara, Inc.
Industrycollaborator
Cardurion Pharmaceuticals, Inc.
Industrylead

Study Sites (36)

Herlev Hospital

Herlev, Capital Region, 2730, Denmark

Institut Universitaire du Cancer de Toulouse Oncopole

Toulouse, Haute-Garonn, 31059, France

Hôpital Edouard Herriot

Lyon, Rhone, 69437, France

Hôpital Necker-Enfants Malades

Paris, 75015, France

M. Zodelava Hematology Centre

Tbilisi, Borjomi, 0112, Georgia

National Center of Surgery

Tbilisi, 0159, Georgia

Medinvest - Institute of Hematology and Transfusiology

Tbilisi, 0186, Georgia

Related Publications (1)

Foong WC, Loh CK, Ho JJ, Lau DS. Foetal haemoglobin inducers for reducing blood transfusion in non-transfusion-dependent beta-thalassaemias. Cochrane Database Syst Rev. 2023 Jan 13;1(1):CD013767. doi: 10.1002/14651858.CD013767.pub2.
PMID: 36637054DERIVED

Results Point of Contact

Title: Rahul Ballal
Organization: Imara, Inc.

Study Officials

Steve Luperchio
Cardurion Pharmaceuticals
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: Yes

Enrollment

122 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: NONE
Masking Details: Double-Blind
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 15, 2020

First Posted

June 2, 2020

Study Start

October 16, 2020

Actual (reported)

Study Stopped

A Study of IMR-687 in Subjects With Beta Thalassemia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (3)

Lower Dose IMR-687

Higher dose IMR-687

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (36)

Related Publications (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations

Study Stopped

A Study of IMR-687 in Subjects With Beta Thalassemia

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (3)

Lower Dose IMR-687

Higher dose IMR-687

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (36)

Related Publications (1)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Documents

Locations